Trial Outcomes & Findings for Treatment and Natural History Study of Lymphomatoid Granulomatosis (NCT NCT00001379)

Last Updated: 2025-06-19

Results Overview

Overall response rate will be classified as the following: complete remission (CR), partial remission (PR), disease progression or disease stabilization measured by the Response Criteria. CR is no evidence of active disease on restaging for at least 2 months duration. All lesions must have decreased by \> 75%, be gallium or positron emission tomography (PET) negative (if obtained) and be stable for \> 3 months without new lesions appearing. PR is 50% or greater decrease in the sum of the products of the diameters of all measurable lesions for at least one month. Disease progression is 25% or greater progression in the sum of the products of the diameter of any measurable lesion over one month or the appearance or any new lesion consistent with metastatic disease. Disease stabilization is no change in the sum of the products of the diameters of all measurable lesions over two months and no new lesions consistent with disease.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

94 participants

Primary outcome timeframe

From study enrollment and throughout treatment, up to a maximum of 40 months for the 2 interferon groups and 8 months for the 2 EPOCH-R groups.

Results posted on

2025-06-19

Participant Flow

Participant milestones

Participant milestones
Measure	Participants Treated With Initial Interferon Therapy Interferon starting at 7.5 million Units subcutaneous (subQ) 3 times a week and increasing on the designated schedule, as tolerated. Participants continue taking interferon for 1 year beyond complete remission (CR). Patients who progress may crossover to receive etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R). Interferon: For lymphomatoid granulomatosis (LYG) Grade 1 and 2: Interferon starting at 7.5 million Units subcutaneous (subQ) 3 times a week and increasing on the following schedule: 10 million U; 15 million U; 20 million U; 25 million U; and increased in 5 million U increments, as tolerated. Participants continue taking interferon for 1 year beyond complete remission (CR).	Treated With Initial Etoposide,Prednisone,Vincristine,Cyclophosphamide,Doxorubicin,Rituximab Therapy Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R) every 3 weeks for up to 6 cycles, based on response. Rituxan and EPOCH: For lymphomatoid granulomatosis (LYG) Grade 3: EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, rituximab) every 3 weeks for 6 cycles. Participants who relapse or progress may crossover to receive interferon.	Participants Enrolled But Not Treated Participants were enrolled and not treated with initial interferon or etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R) therapy.	Participant Treated With Rituximab and Radiation Only Participant treated with rituximab and radiation only. Did not receive either interferon or etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) therapy.
Initial Treatment STARTED	60	28	5	1
Initial Treatment Participants Eligible for Cross-over to EPOCH-R	24	0	0	0
Initial Treatment Participants Eligible for Cross-over to Interferon	0	10	0	0
Initial Treatment Participants Did Not Cross Over to Interferon or EPOCH Therapy After Initial Treatment	36	18	0	0
Initial Treatment COMPLETED	29	23	0	0
Initial Treatment NOT COMPLETED	31	5	5	1
Cross-Over After Initial Treatment STARTED	24	10	0	0
Cross-Over After Initial Treatment Participants Eligible for Cross-over Treated With EPOCH-R	24	0	0	0
Cross-Over After Initial Treatment Participants Eligible for Cross-over Treated With Interferon	0	10	0	0
Cross-Over After Initial Treatment COMPLETED	14	7	0	0
Cross-Over After Initial Treatment NOT COMPLETED	10	3	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Participants Treated With Initial Interferon Therapy Interferon starting at 7.5 million Units subcutaneous (subQ) 3 times a week and increasing on the designated schedule, as tolerated. Participants continue taking interferon for 1 year beyond complete remission (CR). Patients who progress may crossover to receive etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R). Interferon: For lymphomatoid granulomatosis (LYG) Grade 1 and 2: Interferon starting at 7.5 million Units subcutaneous (subQ) 3 times a week and increasing on the following schedule: 10 million U; 15 million U; 20 million U; 25 million U; and increased in 5 million U increments, as tolerated. Participants continue taking interferon for 1 year beyond complete remission (CR).	Treated With Initial Etoposide,Prednisone,Vincristine,Cyclophosphamide,Doxorubicin,Rituximab Therapy Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R) every 3 weeks for up to 6 cycles, based on response. Rituxan and EPOCH: For lymphomatoid granulomatosis (LYG) Grade 3: EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, rituximab) every 3 weeks for 6 cycles. Participants who relapse or progress may crossover to receive interferon.	Participants Enrolled But Not Treated Participants were enrolled and not treated with initial interferon or etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R) therapy.	Participant Treated With Rituximab and Radiation Only Participant treated with rituximab and radiation only. Did not receive either interferon or etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) therapy.
Initial Treatment Disease progression	21	3	0	0
Initial Treatment Complicating disease/intercurrent illness	6	1	0	0
Initial Treatment Received alternative treatment	2	1	0	0
Initial Treatment Refused further treatment	2	0	0	0
Initial Treatment Did not receive protocol treatment	0	0	5	0
Initial Treatment Received treatment with whole brain radiation therapy (WBRT) + Rituximab	0	0	0	1
Cross-Over After Initial Treatment Disease progression	4	2	0	0
Cross-Over After Initial Treatment Complicating disease/intercurrent illness	1	1	0	0
Cross-Over After Initial Treatment Received alternative treatment	4	0	0	0
Cross-Over After Initial Treatment Refused further treatment	1	0	0	0

Baseline Characteristics

Treatment and Natural History Study of Lymphomatoid Granulomatosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants Treated With Initial Interferon Therapy n=60 Participants Interferon starting at 7.5 million Units subcutaneous (subQ) 3 times a week and increasing on the designated schedule, as tolerated. Participants continue taking interferon for 1 year beyond complete remission (CR). Patients who progress may crossover to receive etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R). Interferon: For lymphomatoid granulomatosis (LYG) Grade 1 and 2: Interferon starting at 7.5 million Units subcutaneous (subQ) 3 times a week and increasing on the following schedule: 10 million U; 15 million U; 20 million U; 25 million U; and increased in 5 million U increments, as tolerated. Participants continue taking interferon for 1 year beyond complete remission (CR).	Treated With Initial Etoposide,Prednisone,Vincristine,Cyclophosphamide,Doxorubicin,Rituximab Therapy n=28 Participants Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R) every 3 weeks for up to 6 cycles, based on response. Rituxan and EPOCH: For lymphomatoid granulomatosis (LYG) Grade 3: EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, rituximab) every 3 weeks for 6 cycles. Participants who relapse or progress may crossover to receive interferon.	Participants Enrolled But Not Treated n=5 Participants Participants were enrolled and not treated with initial interferon or etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R) therapy.	Participant Treated With Rituximab and Radiation Only n=1 Participants Participant treated with rituximab and radiation only. Did not receive either interferon or etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) therapy.	Total n=94 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	2 Participants n=36 Participants
Age, Categorical Between 18 and 65 years	54 Participants n=93 Participants	27 Participants n=4 Participants	5 Participants n=27 Participants	1 Participants n=483 Participants	87 Participants n=36 Participants
Age, Categorical >=65 years	5 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	5 Participants n=36 Participants
Age, Continuous	46.6 years STANDARD_DEVIATION 13.88 • n=93 Participants	47.42 years STANDARD_DEVIATION 12.76 • n=4 Participants	42.64 years STANDARD_DEVIATION 12.47 • n=27 Participants	18 years STANDARD_DEVIATION 0 • n=483 Participants	46.33 years STANDARD_DEVIATION 13.64 • n=36 Participants
Sex: Female, Male Female	21 Participants n=93 Participants	14 Participants n=4 Participants	2 Participants n=27 Participants	1 Participants n=483 Participants	38 Participants n=36 Participants
Sex: Female, Male Male	39 Participants n=93 Participants	14 Participants n=4 Participants	3 Participants n=27 Participants	0 Participants n=483 Participants	56 Participants n=36 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	60 Participants n=93 Participants	28 Participants n=4 Participants	5 Participants n=27 Participants	1 Participants n=483 Participants	94 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	3 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	4 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	2 Participants n=36 Participants
Race (NIH/OMB) White	53 Participants n=93 Participants	25 Participants n=4 Participants	5 Participants n=27 Participants	1 Participants n=483 Participants	84 Participants n=36 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	4 Participants n=36 Participants
Region of Enrollment United States	60 participants n=93 Participants	28 participants n=4 Participants	5 participants n=27 Participants	1 participants n=483 Participants	94 participants n=36 Participants
Baseline Histologic Grade of Lymphomatoid Granulomatosis (LYG) Grade 1	22 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	23 Participants n=36 Participants
Baseline Histologic Grade of Lymphomatoid Granulomatosis (LYG) Grade 2	19 Participants n=93 Participants	2 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	22 Participants n=36 Participants
Baseline Histologic Grade of Lymphomatoid Granulomatosis (LYG) Grade 3	13 Participants n=93 Participants	22 Participants n=4 Participants	2 Participants n=27 Participants	0 Participants n=483 Participants	37 Participants n=36 Participants
Baseline Histologic Grade of Lymphomatoid Granulomatosis (LYG) NA	6 Participants n=93 Participants	3 Participants n=4 Participants	2 Participants n=27 Participants	1 Participants n=483 Participants	12 Participants n=36 Participants
Prior Therapy None	16 Participants n=93 Participants	13 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	30 Participants n=36 Participants
Prior Therapy Corticosteroids	42 Participants n=93 Participants	14 Participants n=4 Participants	3 Participants n=27 Participants	1 Participants n=483 Participants	60 Participants n=36 Participants
Prior Therapy Chemotherapy	22 Participants n=93 Participants	4 Participants n=4 Participants	2 Participants n=27 Participants	1 Participants n=483 Participants	29 Participants n=36 Participants
Prior Therapy Rituximab	13 Participants n=93 Participants	3 Participants n=4 Participants	3 Participants n=27 Participants	0 Participants n=483 Participants	19 Participants n=36 Participants
Disease Sites Lung	60 Participants n=93 Participants	28 Participants n=4 Participants	5 Participants n=27 Participants	0 Participants n=483 Participants	93 Participants n=36 Participants
Disease Sites Central nervous system (CNS)	21 Participants n=93 Participants	8 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	30 Participants n=36 Participants
Disease Sites Skin	20 Participants n=93 Participants	11 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	32 Participants n=36 Participants
Disease Sites Kidney	11 Participants n=93 Participants	4 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	15 Participants n=36 Participants
Disease Sites Liver	10 Participants n=93 Participants	6 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	17 Participants n=36 Participants
Disease Sites Spleen	6 Participants n=93 Participants	3 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	10 Participants n=36 Participants
Disease Sites Lymph node	4 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	5 Participants n=36 Participants
Disease Sites Other	9 Participants n=93 Participants	9 Participants n=4 Participants	2 Participants n=27 Participants	0 Participants n=483 Participants	20 Participants n=36 Participants
Elevated lactate hydrogenase (LDH)	31 Participants n=93 Participants	12 Participants n=4 Participants	2 Participants n=27 Participants	0 Participants n=483 Participants	45 Participants n=36 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1	47 Participants n=93 Participants	24 Participants n=4 Participants	5 Participants n=27 Participants	1 Participants n=483 Participants	77 Participants n=36 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ≥2	13 Participants n=93 Participants	4 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	17 Participants n=36 Participants

PRIMARY outcome

Timeframe: From study enrollment and throughout treatment, up to a maximum of 40 months for the 2 interferon groups and 8 months for the 2 EPOCH-R groups.

Population: 9/94 participants were not analyzed because 5 were enrolled and not treated,3 participants died prior to restaging scans, and 1 was treated with rituximab and radiation only.

Outcome measures

Outcome measures
Measure	Participants Treated With Initial Interferon Therapy n=58 Participants Interferon starting at 7.5 million Units subcutaneous (subQ) 3 times a week and increasing on the designated schedule, as tolerated. Participants continue taking interferon for 1 year beyond complete remission (CR). Patients who progress may crossover to receive etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R). Interferon: For lymphomatoid granulomatosis (LYG) Grade 1 and 2: Interferon starting at 7.5 million Units subcutaneous (subQ) 3 times a week and increasing on the following schedule: 10 million U; 15 million U; 20 million U; 25 million U; and increased in 5 million U increments, as tolerated. Participants continue taking interferon for 1 year beyond complete remission (CR).	Treated With Initial Etoposide,Prednisone,Vincristine,Cyclophosphamide,Doxorubicin,Rituximab Therapy n=27 Participants Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R) every 3 weeks for up to 6 cycles, based on response. Rituxan and EPOCH: For lymphomatoid granulomatosis (LYG) Grade 3: EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, rituximab) every 3 weeks for 6 cycles. Participants who relapse or progress may crossover to receive interferon.	Treated With Interferon&Crossed Over - Prednisone,Vincristine,Cyclophosphamide,Doxorubicin,Rituximab n=21 Participants All participants who were treated with initial interferon and crossed over to receive etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R).	Treated With Pednisone,Vincristine,Cyclophosphamide,Doxorubicin,Rituximab&Crossed Over to Interferon n=10 Participants All participants who were treated with initial prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) and crossed over to receive interferon.	Participants Treated With Cross-over Interferon Participants initially treated with etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) who relapse, or progress may crossover to receive interferon.	Participants Treated With Cross-over EPOCH-R Participants initially treated with Interferon who progress may crossover to receive etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R).
Overall Response Rate (ORR) Complete Remission	53.45 percentage of participants Interval 40.8 to 65.67	51.85 percentage of participants Interval 33.99 to 69.26	57.14 percentage of participants Interval 36.55 to 75.53	50.00 percentage of participants Interval 23.66 to 76.34	—	—
Overall Response Rate (ORR) Partial Remission	5.17 percentage of participants Interval 1.14 to 14.14	25.93 percentage of participants Interval 13.17 to 44.68	14.29 percentage of participants Interval 4.98 to 34.64	10.00 percentage of participants Interval 0.51 to 40.12	—	—
Overall Response Rate (ORR) Disease Progression	32.76 percentage of participants Interval 22.08 to 45.58	11.11 percentage of participants Interval 3.85 to 28.06	14.29 percentage of participants Interval 4.98 to 34.64	20.00 percentage of participants Interval 3.55 to 50.98	—	—
Overall Response Rate (ORR) Disease Stabilization	8.62 percentage of participants Interval 3.74 to 18.64	11.11 percentage of participants Interval 3.85 to 28.06	14.29 percentage of participants Interval 4.98 to 34.64	20.00 percentage of participants Interval 3.55 to 50.98	—	—

PRIMARY outcome

Timeframe: Assessed from date of study enrollment until time of disease relapse, disease progression, death, or last follow-up, whichever comes first, up to a maximum of 27 years for the 2 interferon groups and 20 years for the 2 EPOCH-R groups.

Population: 6/94 participants were not analyzed because 5 were enrolled and not treated, and 1 was treated with rituximab and radiation only.

PFS is defined as the duration of time from the date of study enrollment until the date of disease relapse, disease progression, death, or last follow-up, whichever occurs first, using the Kaplan-Meier method. Response was assessed by the Lugano Classification Response Criteria for Non-Hodgkin lymphoma (NHL). Disease progression is defined as an increase of ≥ 50% from the product of the perpendicular diameter (PPD) nadir and an increase in longest transverse diameter of a lesion (LDi) or shortest axis perpendicular diameter (SDi) from nadir of \>0.5 cm for lesions \<2 cm or \>1.0 cm for lesions \>2 cm.

Outcome measures

Outcome measures
Measure	Participants Treated With Initial Interferon Therapy n=60 Participants Interferon starting at 7.5 million Units subcutaneous (subQ) 3 times a week and increasing on the designated schedule, as tolerated. Participants continue taking interferon for 1 year beyond complete remission (CR). Patients who progress may crossover to receive etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R). Interferon: For lymphomatoid granulomatosis (LYG) Grade 1 and 2: Interferon starting at 7.5 million Units subcutaneous (subQ) 3 times a week and increasing on the following schedule: 10 million U; 15 million U; 20 million U; 25 million U; and increased in 5 million U increments, as tolerated. Participants continue taking interferon for 1 year beyond complete remission (CR).	Treated With Initial Etoposide,Prednisone,Vincristine,Cyclophosphamide,Doxorubicin,Rituximab Therapy n=28 Participants Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R) every 3 weeks for up to 6 cycles, based on response. Rituxan and EPOCH: For lymphomatoid granulomatosis (LYG) Grade 3: EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, rituximab) every 3 weeks for 6 cycles. Participants who relapse or progress may crossover to receive interferon.	Treated With Interferon&Crossed Over - Prednisone,Vincristine,Cyclophosphamide,Doxorubicin,Rituximab n=24 Participants All participants who were treated with initial interferon and crossed over to receive etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R).	Treated With Pednisone,Vincristine,Cyclophosphamide,Doxorubicin,Rituximab&Crossed Over to Interferon n=10 Participants All participants who were treated with initial prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) and crossed over to receive interferon.	Participants Treated With Cross-over Interferon Participants initially treated with etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) who relapse, or progress may crossover to receive interferon.	Participants Treated With Cross-over EPOCH-R Participants initially treated with Interferon who progress may crossover to receive etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R).
Progression Free Survival (PFS)	1.01 years Interval 0.61 to 6.54	0.69 years Interval 0.45 to 8.43	0.23 years Interval 0.14 to 0.49	0.53 years Interval 0.33 to Confidence intervals are generated via the Brookmeyer-Crowley method (if a limit of the confidence interval does not intersect the median, then it is recorded as not estimable (i.e., NA).	—	—

SECONDARY outcome

Timeframe: Assessed from date of study enrollment until time of death or last follow-up, whichever comes first, up to a maximum of 27 years.

Population: 6/94 participants were not analyzed because 5 were enrolled and not treated and 1 was treated with rituximab and radiation only.

OS is defined as the time from treatment start date until date of death or date last known alive. The median OS will be determined and reported along with a 95% confidence interval.

Outcome measures

Outcome measures
Measure	Participants Treated With Initial Interferon Therapy n=60 Participants Interferon starting at 7.5 million Units subcutaneous (subQ) 3 times a week and increasing on the designated schedule, as tolerated. Participants continue taking interferon for 1 year beyond complete remission (CR). Patients who progress may crossover to receive etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R). Interferon: For lymphomatoid granulomatosis (LYG) Grade 1 and 2: Interferon starting at 7.5 million Units subcutaneous (subQ) 3 times a week and increasing on the following schedule: 10 million U; 15 million U; 20 million U; 25 million U; and increased in 5 million U increments, as tolerated. Participants continue taking interferon for 1 year beyond complete remission (CR).	Treated With Initial Etoposide,Prednisone,Vincristine,Cyclophosphamide,Doxorubicin,Rituximab Therapy n=28 Participants Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R) every 3 weeks for up to 6 cycles, based on response. Rituxan and EPOCH: For lymphomatoid granulomatosis (LYG) Grade 3: EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, rituximab) every 3 weeks for 6 cycles. Participants who relapse or progress may crossover to receive interferon.	Treated With Interferon&Crossed Over - Prednisone,Vincristine,Cyclophosphamide,Doxorubicin,Rituximab n=24 Participants All participants who were treated with initial interferon and crossed over to receive etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R).	Treated With Pednisone,Vincristine,Cyclophosphamide,Doxorubicin,Rituximab&Crossed Over to Interferon n=10 Participants All participants who were treated with initial prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) and crossed over to receive interferon.	Participants Treated With Cross-over Interferon Participants initially treated with etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) who relapse, or progress may crossover to receive interferon.	Participants Treated With Cross-over EPOCH-R Participants initially treated with Interferon who progress may crossover to receive etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R).
Overall Survival (OS)	12.22 years Interval 7.29 to Confidence intervals are generated via the Brookmeyer-Crowley method (if a limit of the confidence interval does not intersect the median, then it is recorded as not estimable (i.e., NA).	9.84 years Interval 3.35 to Confidence intervals are generated via the Brookmeyer-Crowley method (if a limit of the confidence interval does not intersect the median, then it is recorded as not estimable (i.e., NA).	8.43 years Interval 2.66 to Confidence intervals are generated via the Brookmeyer-Crowley method (if a limit of the confidence interval does not intersect the median, then it is recorded as not estimable (i.e., NA).	12.13 years Interval 2.89 to Confidence intervals are generated via the Brookmeyer-Crowley method (if a limit of the confidence interval does not intersect the median, then it is recorded as not estimable (i.e., NA).	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months.

Population: 5 participants who were followed and not treated on study were followed for survival and mortality.

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Toxicity Criteria (CTC v2.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	Participants Treated With Initial Interferon Therapy n=60 Participants Interferon starting at 7.5 million Units subcutaneous (subQ) 3 times a week and increasing on the designated schedule, as tolerated. Participants continue taking interferon for 1 year beyond complete remission (CR). Patients who progress may crossover to receive etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R). Interferon: For lymphomatoid granulomatosis (LYG) Grade 1 and 2: Interferon starting at 7.5 million Units subcutaneous (subQ) 3 times a week and increasing on the following schedule: 10 million U; 15 million U; 20 million U; 25 million U; and increased in 5 million U increments, as tolerated. Participants continue taking interferon for 1 year beyond complete remission (CR).	Treated With Initial Etoposide,Prednisone,Vincristine,Cyclophosphamide,Doxorubicin,Rituximab Therapy n=28 Participants Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R) every 3 weeks for up to 6 cycles, based on response. Rituxan and EPOCH: For lymphomatoid granulomatosis (LYG) Grade 3: EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, rituximab) every 3 weeks for 6 cycles. Participants who relapse or progress may crossover to receive interferon.	Treated With Interferon&Crossed Over - Prednisone,Vincristine,Cyclophosphamide,Doxorubicin,Rituximab n=5 Participants All participants who were treated with initial interferon and crossed over to receive etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R).	Treated With Pednisone,Vincristine,Cyclophosphamide,Doxorubicin,Rituximab&Crossed Over to Interferon n=1 Participants All participants who were treated with initial prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) and crossed over to receive interferon.	Participants Treated With Cross-over Interferon n=10 Participants Participants initially treated with etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) who relapse, or progress may crossover to receive interferon.	Participants Treated With Cross-over EPOCH-R n=24 Participants Participants initially treated with Interferon who progress may crossover to receive etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R).
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Toxicity Criteria (CTC v2.0)	57 Participants	28 Participants	0 Participants	1 Participants	10 Participants	24 Participants

Adverse Events

Participants Treated With Initial Interferon Therapy

Serious events: 21 serious events

Other events: 57 other events

Deaths: 29 deaths

Treated With Initial Etoposide,Prednisone,Vincristine,Cyclophosphamide,Doxorubicin,Rituximab Therapy

Serious events: 20 serious events

Other events: 28 other events

Deaths: 15 deaths

Participants Enrolled But Not Treated

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Participant Treated With Rituximab and Radiation Only

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Participants Treated With Cross-over EPOCH-R

Serious events: 15 serious events

Other events: 24 other events

Deaths: 14 deaths

Participants Treated With Cross-over Interferon

Serious events: 6 serious events

Other events: 10 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Participants Treated With Initial Interferon Therapy n=60 participants at risk Interferon starting at 7.5 million Units subcutaneous (subQ) 3 times a week and increasing on the designated schedule, as tolerated. Participants continue taking interferon for 1 year beyond complete remission (CR). Patients who progress may crossover to receive etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R). Interferon: For lymphomatoid granulomatosis (LYG) Grade 1 and 2: Interferon starting at 7.5 million Units subcutaneous (subQ) 3 times a week and increasing on the following schedule: 10 million U; 15 million U; 20 million U; 25 million U; and increased in 5 million U increments, as tolerated. Participants continue taking interferon for 1 year beyond complete remission (CR).	Treated With Initial Etoposide,Prednisone,Vincristine,Cyclophosphamide,Doxorubicin,Rituximab Therapy n=28 participants at risk Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R) every 3 weeks for up to 6 cycles, based on response. Rituxan and EPOCH: For lymphomatoid granulomatosis (LYG) Grade 3: EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, rituximab) every 3 weeks for 6 cycles. Participants who relapse or progress may crossover to receive interferon.	Participants Enrolled But Not Treated n=5 participants at risk Participants were enrolled and not treated with initial interferon or etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R) therapy. 5 participants were followed and not treated on study were followed for survival and mortality.	Participant Treated With Rituximab and Radiation Only n=1 participants at risk Participant treated with rituximab and radiation only. Did not receive either interferon or etoposide/prednisone/vincristine/cyclophosphamide/doxorubicin/rituximab therapy.	Participants Treated With Cross-over EPOCH-R n=24 participants at risk Participants initially treated with Interferon who progress may crossover to receive etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R).	Participants Treated With Cross-over Interferon n=10 participants at risk Participants initially treated with etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) who relapse, or progress may crossover to receive interferon.
Gastrointestinal disorders Diarrhea	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Hepatobiliary disorders ALT, SGPT (serum glutamic pyruvic transaminase)	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Respiratory, thoracic and mediastinal disorders Adult Respiratory Distress Syndrome (ARDS)	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Nervous system disorders CNS cerebrovascular ischemia	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Cardiac disorders Cardiac Arrhythmia - Other (Specify, __): sinus bradycardia	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Blood and lymphatic system disorders Coagulation - Other (Specify, __): HPS	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Gastrointestinal disorders Colitis	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Nervous system disorders Confusion	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
General disorders Death not associated with CTCAE term::Death NOS	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
General disorders Death not associated with CTCAE term::Disease progression NOS	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Febrile neutropenia	16.7% 10/60 • Number of events 18 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	50.0% 14/28 • Number of events 34 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	41.7% 10/24 • Number of events 18 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	40.0% 4/10 • Number of events 8 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	3.3% 2/60 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Gastrointestinal disorders Gastrointestinal - Other (Specify, __): Worsening GERD	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection - Other (Specify, __): Thyroid	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Bladder (urinary)	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Blood	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Bronchus	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)	3.3% 2/60 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection with unknown ANC::Lung (pneumonia)	3.3% 2/60 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection with unknown ANC::Rectum	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Blood and lymphatic system disorders Leukocytes (total WBC)	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	7.1% 2/28 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Gastrointestinal disorders Nausea	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Nervous system disorders Neuropathy: motor	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	7.1% 2/28 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Musculoskeletal and connective tissue disorders Pain::Bone	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Musculoskeletal and connective tissue disorders Pain::Chest wall	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Nervous system disorders Seizure	5.0% 3/60 • Number of events 4 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Nervous system disorders Somnolence/depressed level of consciousness	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Nervous system disorders Syncope (fainting)	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Cardiac disorders Thrombosis/thrombus/embolism	6.7% 4/60 • Number of events 4 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	12.5% 3/24 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Cardiac disorders Thrombotic microangiopathy	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Gastrointestinal disorders Vomiting	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.

Other adverse events

Other adverse events
Measure	Participants Treated With Initial Interferon Therapy n=60 participants at risk Interferon starting at 7.5 million Units subcutaneous (subQ) 3 times a week and increasing on the designated schedule, as tolerated. Participants continue taking interferon for 1 year beyond complete remission (CR). Patients who progress may crossover to receive etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R). Interferon: For lymphomatoid granulomatosis (LYG) Grade 1 and 2: Interferon starting at 7.5 million Units subcutaneous (subQ) 3 times a week and increasing on the following schedule: 10 million U; 15 million U; 20 million U; 25 million U; and increased in 5 million U increments, as tolerated. Participants continue taking interferon for 1 year beyond complete remission (CR).	Treated With Initial Etoposide,Prednisone,Vincristine,Cyclophosphamide,Doxorubicin,Rituximab Therapy n=28 participants at risk Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R) every 3 weeks for up to 6 cycles, based on response. Rituxan and EPOCH: For lymphomatoid granulomatosis (LYG) Grade 3: EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, rituximab) every 3 weeks for 6 cycles. Participants who relapse or progress may crossover to receive interferon.	Participants Enrolled But Not Treated n=5 participants at risk Participants were enrolled and not treated with initial interferon or etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R) therapy. 5 participants were followed and not treated on study were followed for survival and mortality.	Participant Treated With Rituximab and Radiation Only n=1 participants at risk Participant treated with rituximab and radiation only. Did not receive either interferon or etoposide/prednisone/vincristine/cyclophosphamide/doxorubicin/rituximab therapy.	Participants Treated With Cross-over EPOCH-R n=24 participants at risk Participants initially treated with Interferon who progress may crossover to receive etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R).	Participants Treated With Cross-over Interferon n=10 participants at risk Participants initially treated with etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R) who relapse, or progress may crossover to receive interferon.
Hepatobiliary disorders ALT, SGPT (serum glutamic pyruvic transaminase)	58.3% 35/60 • Number of events 64 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	57.1% 16/28 • Number of events 32 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	70.8% 17/24 • Number of events 44 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	90.0% 9/10 • Number of events 23 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Hepatobiliary disorders AST, SGOT(serum glutamic oxaloacetic transaminase)	56.7% 34/60 • Number of events 55 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	39.3% 11/28 • Number of events 21 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	75.0% 18/24 • Number of events 36 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	70.0% 7/10 • Number of events 15 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Hepatobiliary disorders Albumin, serum-low (hypoalbuminemia)	53.3% 32/60 • Number of events 46 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	57.1% 16/28 • Number of events 31 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	70.8% 17/24 • Number of events 31 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	60.0% 6/10 • Number of events 12 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Hepatobiliary disorders Alkaline phosphatase	45.0% 27/60 • Number of events 40 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	32.1% 9/28 • Number of events 11 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	62.5% 15/24 • Number of events 28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	50.0% 5/10 • Number of events 6 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Immune system disorders Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)	10.0% 6/60 • Number of events 6 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	46.4% 13/28 • Number of events 16 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	12.5% 3/24 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	40.0% 4/10 • Number of events 6 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Immune system disorders Allergy/Immunology - Other (Specify, __): perioral/ nasal fullness	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Gastrointestinal disorders Anorexia	40.0% 24/60 • Number of events 30 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	50.0% 14/28 • Number of events 19 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	70.8% 17/24 • Number of events 22 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	70.0% 7/10 • Number of events 12 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Nervous system disorders Ataxia (incoordination)	3.3% 2/60 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Ear and labyrinth disorders Auditory/Ear - Other (Specify, __): Vertigo	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Metabolism and nutrition disorders Bicarbonate, serum-low	3.3% 2/60 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.7% 3/28 • Number of events 4 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Hepatobiliary disorders Bilirubin (hyperbilirubinemia)	13.3% 8/60 • Number of events 14 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	21.4% 6/28 • Number of events 11 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	20.8% 5/24 • Number of events 10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	30.0% 3/10 • Number of events 7 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Nervous system disorders CNS cerebrovascular ischemia	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Metabolism and nutrition disorders CPK (creatine phosphokinase)	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Metabolism and nutrition disorders Calcium, serum-high (hypercalcemia)	10.0% 6/60 • Number of events 6 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	14.3% 4/28 • Number of events 4 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	16.7% 4/24 • Number of events 4 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	20.0% 2/10 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	31.7% 19/60 • Number of events 31 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	35.7% 10/28 • Number of events 14 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	45.8% 11/24 • Number of events 21 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	50.0% 5/10 • Number of events 8 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Skin and subcutaneous tissue disorders Cheilitis	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Blood and lymphatic system disorders Coagulation - Other (Specify, __): HPS	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Cardiac disorders Conduction abnormality/atrioventricular heart block::AV Block-Second degree Mobitz Type II	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Nervous system disorders Confusion	3.3% 2/60 • Number of events 5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	7.1% 2/28 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 4 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Gastrointestinal disorders Constipation	25.0% 15/60 • Number of events 19 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	57.1% 16/28 • Number of events 24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	37.5% 9/24 • Number of events 11 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	70.0% 7/10 • Number of events 9 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Respiratory, thoracic and mediastinal disorders Cough	35.0% 21/60 • Number of events 22 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	39.3% 11/28 • Number of events 14 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	45.8% 11/24 • Number of events 12 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	60.0% 6/10 • Number of events 8 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Renal and urinary disorders Creatinine	5.0% 3/60 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Endocrine disorders Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity, cutaneous striae)	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Gastrointestinal disorders Dehydration	1.7% 1/60 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	7.1% 2/28 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Gastrointestinal disorders Diarrhea	26.7% 16/60 • Number of events 30 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	50.0% 14/28 • Number of events 22 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	50.0% 12/24 • Number of events 26 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	60.0% 6/10 • Number of events 10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Gastrointestinal disorders Distension/bloating, abdominal	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Nervous system disorders Dizziness	20.0% 12/60 • Number of events 13 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	42.9% 12/28 • Number of events 14 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	25.0% 6/24 • Number of events 7 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	60.0% 6/10 • Number of events 7 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Eye disorders Dry eye syndrome	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Gastrointestinal disorders Dry mouth/salivary gland (xerostomia)	3.3% 2/60 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.7% 3/28 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Skin and subcutaneous tissue disorders Dry skin	6.7% 4/60 • Number of events 5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	14.3% 4/28 • Number of events 4 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	8.3% 2/24 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	30.0% 3/10 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Gastrointestinal disorders Dysphagia (difficulty swallowing)	3.3% 2/60 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	25.0% 15/60 • Number of events 18 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	50.0% 14/28 • Number of events 24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	33.3% 8/24 • Number of events 11 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	80.0% 8/10 • Number of events 16 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Blood and lymphatic system disorders Edema: limb	13.3% 8/60 • Number of events 13 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	32.1% 9/28 • Number of events 12 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	20.8% 5/24 • Number of events 10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	40.0% 4/10 • Number of events 6 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Reproductive system and breast disorders Erectile dysfunction	11.7% 7/60 • Number of events 7 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	7.1% 2/28 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	12.5% 3/24 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Gastrointestinal disorders Esophagitis	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Nervous system disorders Extrapyramidal/involuntary movement/restlessness	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
General disorders Fatigue (asthenia, lethargy, malaise)	80.0% 48/60 • Number of events 75 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	89.3% 25/28 • Number of events 62 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	91.7% 22/24 • Number of events 44 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	100.0% 10/10 • Number of events 32 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Febrile neutropenia	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	14.3% 4/28 • Number of events 5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	56.7% 34/60 • Number of events 45 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	53.6% 15/28 • Number of events 28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	66.7% 16/24 • Number of events 27 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	70.0% 7/10 • Number of events 17 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Gastrointestinal disorders Flatulence	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Skin and subcutaneous tissue disorders Flushing	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	14.3% 4/28 • Number of events 5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	30.0% 3/10 • Number of events 4 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Hepatobiliary disorders GGT (gamma-Glutamyl transpeptidase)	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	33.3% 20/60 • Number of events 40 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	64.3% 18/28 • Number of events 41 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	50.0% 12/24 • Number of events 30 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	60.0% 6/10 • Number of events 16 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Metabolism and nutrition disorders Glucose, serum-low (hypoglycemia)	5.0% 3/60 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	7.1% 2/28 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Skin and subcutaneous tissue disorders Hair loss/alopecia (scalp or body)	23.3% 14/60 • Number of events 21 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	53.6% 15/28 • Number of events 18 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	54.2% 13/24 • Number of events 20 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	60.0% 6/10 • Number of events 7 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Ear and labyrinth disorders Hearing: patients without baseline audiogram and not enrolled in a monitoring program	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	7.1% 2/28 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Gastrointestinal disorders Heartburn/dyspepsia	10.0% 6/60 • Number of events 6 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	17.9% 5/28 • Number of events 5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	12.5% 3/24 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	20.0% 2/10 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Renal and urinary disorders Hemoglobin	63.3% 38/60 • Number of events 92 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	89.3% 25/28 • Number of events 86 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	75.0% 18/24 • Number of events 70 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	90.0% 9/10 • Number of events 29 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Nervous system disorders Hemorrhage, CNS	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Gastrointestinal disorders Hemorrhage, GI::Rectum	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	14.3% 4/28 • Number of events 5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Renal and urinary disorders Hemorrhage, GU::Urinary NOS	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	7.1% 2/28 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	20.0% 2/10 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory::Bronchopulmonary NOS	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory::Nose	3.3% 2/60 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.7% 3/28 • Number of events 5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	20.0% 2/10 • Number of events 4 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory::Respiratory tract NOS	1.7% 1/60 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Endocrine disorders Hot flashes/flushes	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Skin and subcutaneous tissue disorders Hyperpigmentation	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Cardiac disorders Hypertension	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Cardiac disorders Hypotension	10.0% 6/60 • Number of events 7 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.7% 3/28 • Number of events 7 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	20.8% 5/24 • Number of events 6 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Respiratory, thoracic and mediastinal disorders Hypoxia	8.3% 5/60 • Number of events 5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	20.8% 5/24 • Number of events 5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Gastrointestinal disorders Ileus, GI (functional obstruction of bowel, i.e., neuro-constipation)	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Gastrointestinal disorders Incontinence, anal	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Renal and urinary disorders Incontinence, urinary	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection	5.0% 3/60 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	12.5% 3/24 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection - Other (Specify, __): Fingernail	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection - Other (Specify, __): Giardia	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection - Other (Specify, __): Shingles	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection - Other (Specify, __): ingrown nail	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection - Other (Specify, __): r/t PICC	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection - Other (Specify, __): thrush, URI, inner ear	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Bladder (urinary)	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Blood	5.0% 3/60 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	7.1% 2/28 • Number of events 4 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	12.5% 3/24 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Bronchus	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Colon	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Dental-tooth	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::External ear (otitis externa)	3.3% 2/60 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Eye NOS	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Lip/perioral	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)	6.7% 4/60 • Number of events 6 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.7% 3/28 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	12.5% 3/24 • Number of events 4 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Mucosa	5.0% 3/60 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	12.5% 3/24 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Neck NOS	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Nerve-peripheral	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Peritoneal cavity	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Rectum	8.3% 5/60 • Number of events 5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	20.8% 5/24 • Number of events 5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.7% 3/28 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Upper aerodigestive NOS	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS	11.7% 7/60 • Number of events 8 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	20.8% 5/24 • Number of events 6 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS	6.7% 4/60 • Number of events 5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	12.5% 3/24 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Vagina	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Vein	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection with unknown ANC::Anal/perianal	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection with unknown ANC::Bronchus	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Infections and infestations Infection with unknown ANC::Mucosa	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Skin and subcutaneous tissue disorders Injection site reaction/extravasation changes	6.7% 4/60 • Number of events 4 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	7.1% 2/28 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	20.0% 2/10 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Nervous system disorders Insomnia	30.0% 18/60 • Number of events 22 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	25.0% 7/28 • Number of events 7 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	41.7% 10/24 • Number of events 14 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	20.0% 2/10 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Reproductive system and breast disorders Irregular menses (change from baseline)	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.7% 3/28 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Blood and lymphatic system disorders Leukocytes (total WBC)	66.7% 40/60 • Number of events 131 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	89.3% 25/28 • Number of events 106 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	79.2% 19/24 • Number of events 105 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	80.0% 8/10 • Number of events 36 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Nervous system disorders Leukoencephalopathy (radiographic findings)	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Blood and lymphatic system disorders Lymphopenia	63.3% 38/60 • Number of events 70 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	75.0% 21/28 • Number of events 64 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	70.8% 17/24 • Number of events 49 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	80.0% 8/10 • Number of events 20 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Metabolism and nutrition disorders Magnesium, serum-high (hypermagnesemia)	21.7% 13/60 • Number of events 26 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	25.0% 7/28 • Number of events 11 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	37.5% 9/24 • Number of events 22 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	40.0% 4/10 • Number of events 7 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Metabolism and nutrition disorders Magnesium, serum-low (hypomagnesemia)	18.3% 11/60 • Number of events 17 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	39.3% 11/28 • Number of events 22 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	29.2% 7/24 • Number of events 13 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	30.0% 3/10 • Number of events 5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Nervous system disorders Memory impairment	11.7% 7/60 • Number of events 7 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	7.1% 2/28 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	16.7% 4/24 • Number of events 4 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	20.0% 2/10 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Nervous system disorders Mood alteration::Agitation	6.7% 4/60 • Number of events 4 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Nervous system disorders Mood alteration::Anxiety	10.0% 6/60 • Number of events 7 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	16.7% 4/24 • Number of events 4 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Nervous system disorders Mood alteration::Depression	33.3% 20/60 • Number of events 22 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	21.4% 6/28 • Number of events 8 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	33.3% 8/24 • Number of events 8 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	50.0% 5/10 • Number of events 7 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Gastrointestinal disorders Mucositis/stomatitis (clinical exam)::Oral cavity	26.7% 16/60 • Number of events 40 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	67.9% 19/28 • Number of events 42 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	66.7% 16/24 • Number of events 40 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	80.0% 8/10 • Number of events 24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Gastrointestinal disorders Mucositis/stomatitis (functional/symptomatic)::Oral cavity	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	7.1% 2/28 • Number of events 7 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Gastrointestinal disorders Mucositis/stomatitis (functional/symptomatic)::Pharynx	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy)::Extremity-lower	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy)::Whole body/generalized	8.3% 5/60 • Number of events 7 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	42.9% 12/28 • Number of events 12 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	16.7% 4/24 • Number of events 6 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	50.0% 5/10 • Number of events 5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Musculoskeletal and connective tissue disorders Musculoskeletal/Soft Tissue - Other (Specify, __): Fracture-L humerus	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Skin and subcutaneous tissue disorders Nail changes	3.3% 2/60 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	14.3% 4/28 • Number of events 4 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Gastrointestinal disorders Nausea	43.3% 26/60 • Number of events 33 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	60.7% 17/28 • Number of events 29 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	50.0% 12/24 • Number of events 16 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	80.0% 8/10 • Number of events 15 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Nervous system disorders Neurology - Other (Specify, __): Increased peripheral motor neuropathy	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Nervous system disorders Neurology - Other (Specify, __): Increased peripheral sensory neuropathy	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Nervous system disorders Neurology - Other (Specify, __): Peripheral sensory neuropathy	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Nervous system disorders Neuropathy: cranial::CN II Vision	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Nervous system disorders Neuropathy: motor	15.0% 9/60 • Number of events 10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.7% 3/28 • Number of events 4 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	29.2% 7/24 • Number of events 8 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Nervous system disorders Neuropathy: sensory	36.7% 22/60 • Number of events 30 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	67.9% 19/28 • Number of events 33 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	58.3% 14/24 • Number of events 22 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	80.0% 8/10 • Number of events 18 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	60.0% 36/60 • Number of events 119 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	89.3% 25/28 • Number of events 91 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	83.3% 20/24 • Number of events 102 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	80.0% 8/10 • Number of events 32 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Eye disorders Ocular/Visual - Other (Specify, __): b/l optic neuritis	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Ear and labyrinth disorders Otitis, middle ear (non-infectious)	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Blood and lymphatic system disorders PTT (Partial Thromboplastin Time)	10.0% 6/60 • Number of events 6 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.7% 3/28 • Number of events 5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	16.7% 4/24 • Number of events 4 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Skin and subcutaneous tissue disorders Pain - Other (Specify, __): Injection Site	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Skin and subcutaneous tissue disorders Pain - Other (Specify, __): Injection site	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Skin and subcutaneous tissue disorders Pain - Other (Specify, __): PICC site	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Gastrointestinal disorders Pain::Abdomen NOS	15.0% 9/60 • Number of events 10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	7.1% 2/28 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	20.8% 5/24 • Number of events 6 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	20.0% 2/10 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Gastrointestinal disorders Pain::Anus	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Musculoskeletal and connective tissue disorders Pain::Back	5.0% 3/60 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.7% 3/28 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	20.0% 2/10 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Musculoskeletal and connective tissue disorders Pain::Bone	15.0% 9/60 • Number of events 16 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	50.0% 14/28 • Number of events 27 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	33.3% 8/24 • Number of events 15 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	50.0% 5/10 • Number of events 10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Cardiac disorders Pain::Cardiac/heart	3.3% 2/60 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Musculoskeletal and connective tissue disorders Pain::Chest wall	5.0% 3/60 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Musculoskeletal and connective tissue disorders Pain::Chest/thorax NOS	6.7% 4/60 • Number of events 4 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.7% 3/28 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	12.5% 3/24 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	20.0% 2/10 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Gastrointestinal disorders Pain::Dental/teeth/periodontal	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Ear and labyrinth disorders Pain::External ear	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
General disorders Pain::Extremity-limb	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Eye disorders Pain::Eye	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
General disorders Pain::Face	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	7.1% 2/28 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Nervous system disorders Pain::Head/headache	36.7% 22/60 • Number of events 28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	46.4% 13/28 • Number of events 19 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	33.3% 8/24 • Number of events 13 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	70.0% 7/10 • Number of events 11 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Musculoskeletal and connective tissue disorders Pain::Joint	21.7% 13/60 • Number of events 16 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	7.1% 2/28 • Number of events 6 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	33.3% 8/24 • Number of events 10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	20.0% 2/10 • Number of events 6 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Renal and urinary disorders Pain::Kidney	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Ear and labyrinth disorders Pain::Middle ear	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	7.1% 2/28 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	20.0% 2/10 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Musculoskeletal and connective tissue disorders Pain::Muscle	38.3% 23/60 • Number of events 32 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	28.6% 8/28 • Number of events 14 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	45.8% 11/24 • Number of events 16 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	50.0% 5/10 • Number of events 11 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Musculoskeletal and connective tissue disorders Pain::Neck	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Nervous system disorders Pain::Neuralgia/peripheral nerve	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Reproductive system and breast disorders Pain::Pelvis	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Reproductive system and breast disorders Pain::Testicle	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Gastrointestinal disorders Pain::Throat/pharynx/larynx	5.0% 3/60 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.7% 3/28 • Number of events 4 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Renal and urinary disorders Pain::Urethra	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Cardiac disorders Palpitations	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Nervous system disorders Personality/behavioral	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Blood and lymphatic system disorders Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Metabolism and nutrition disorders Phosphate, serum-low (hypophosphatemia)	10.0% 6/60 • Number of events 8 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	17.9% 5/28 • Number of events 7 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	8.3% 2/24 • Number of events 4 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	20.0% 2/10 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Skin and subcutaneous tissue disorders Photosensitivity	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Blood and lymphatic system disorders Platelets	63.3% 38/60 • Number of events 95 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	92.9% 26/28 • Number of events 106 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	83.3% 20/24 • Number of events 76 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	90.0% 9/10 • Number of events 38 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Metabolism and nutrition disorders Potassium, serum-high (hyperkalemia)	8.3% 5/60 • Number of events 5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.7% 3/28 • Number of events 5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	16.7% 4/24 • Number of events 4 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	20.0% 12/60 • Number of events 17 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	21.4% 6/28 • Number of events 14 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	29.2% 7/24 • Number of events 12 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	40.0% 4/10 • Number of events 8 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Gastrointestinal disorders Proctitis	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Skin and subcutaneous tissue disorders Pruritus/itching	13.3% 8/60 • Number of events 8 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	7.1% 2/28 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	20.8% 5/24 • Number of events 5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	20.0% 2/10 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Nervous system disorders Psychosis (hallucinations/delusions)	3.3% 2/60 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other (Specify, __): INFECTION	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other (Specify, __): Respiratory Failure	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Skin and subcutaneous tissue disorders Rash/desquamation	16.7% 10/60 • Number of events 13 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	28.6% 8/28 • Number of events 13 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	29.2% 7/24 • Number of events 8 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	50.0% 5/10 • Number of events 8 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Skin and subcutaneous tissue disorders Rash: acne/acneiform	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Skin and subcutaneous tissue disorders Rash: dermatitis associated with radiation::Radiation	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Skin and subcutaneous tissue disorders Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Renal and urinary disorders Renal failure	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Renal and urinary disorders Renal/Genitourinary - Other (Specify, __): Urinary tract infection	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
General disorders Rigors/chills	36.7% 22/60 • Number of events 26 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	35.7% 10/28 • Number of events 12 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	45.8% 11/24 • Number of events 14 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	80.0% 8/10 • Number of events 10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Secondary Malignancy - possibly related to cancer treatment (Specify, __)	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Nervous system disorders Seizure	3.3% 2/60 • Number of events 4 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	8.3% 2/24 • Number of events 4 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Metabolism and nutrition disorders Sodium, serum-high (hypernatremia)	21.7% 13/60 • Number of events 19 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.7% 3/28 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	29.2% 7/24 • Number of events 12 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	25.0% 15/60 • Number of events 20 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	57.1% 16/28 • Number of events 33 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	45.8% 11/24 • Number of events 15 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	60.0% 6/10 • Number of events 19 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Nervous system disorders Somnolence/depressed level of consciousness	3.3% 2/60 • Number of events 4 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Cardiac disorders Supraventricular and nodal arrhythmia::Atrial fibrillation	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Cardiac disorders Supraventricular and nodal arrhythmia::Sinus arrhythmia	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Cardiac disorders Supraventricular and nodal arrhythmia::Sinus tachycardia	8.3% 5/60 • Number of events 5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	14.3% 4/28 • Number of events 4 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	12.5% 3/24 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Cardiac disorders Supraventricular and nodal arrhythmia::Supraventricular arrhythmia NOS	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
General disorders Sweating (diaphoresis)	13.3% 8/60 • Number of events 9 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	25.0% 7/28 • Number of events 7 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	16.7% 4/24 • Number of events 4 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	50.0% 5/10 • Number of events 5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Nervous system disorders Syncope (fainting)	5.0% 3/60 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	12.5% 3/24 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Gastrointestinal disorders Taste alteration (dysgeusia)	18.3% 11/60 • Number of events 13 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	32.1% 9/28 • Number of events 11 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	33.3% 8/24 • Number of events 10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	50.0% 5/10 • Number of events 6 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Cardiac disorders Thrombosis/embolism (vascular access-related)	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Cardiac disorders Thrombosis/thrombus/embolism	8.3% 5/60 • Number of events 5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.7% 3/28 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	16.7% 4/24 • Number of events 4 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Endocrine disorders Thyroid function, high (hyperthyroidism, thyrotoxicosis)	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Endocrine disorders Thyroid function, low (hypothyroidism)	5.0% 3/60 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Nervous system disorders Tremor	6.7% 4/60 • Number of events 6 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	8.3% 2/24 • Number of events 4 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Skin and subcutaneous tissue disorders Ulceration	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Metabolism and nutrition disorders Uric acid, serum-high (hyperuricemia)	3.3% 2/60 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Renal and urinary disorders Urinary frequency/urgency	3.3% 2/60 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	8.3% 2/24 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Renal and urinary disorders Urinary retention (including neurogenic bladder)	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Cardiac disorders Vascular - Other (Specify, __): Thromboembolic event	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Cardiac disorders Ventricular arrhythmia::Ventricular arrhythmia NOS	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Eye disorders Vision-blurred vision	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.7% 3/28 • Number of events 3 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Eye disorders Vision-photophobia	1.7% 1/60 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Respiratory, thoracic and mediastinal disorders Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)	1.7% 1/60 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	3.6% 1/28 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	4.2% 1/24 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	10.0% 1/10 • Number of events 1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Gastrointestinal disorders Vomiting	21.7% 13/60 • Number of events 22 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	46.4% 13/28 • Number of events 20 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	33.3% 8/24 • Number of events 14 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	60.0% 6/10 • Number of events 11 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
Eye disorders Watery eye (epiphora, tearing)	0.00% 0/60 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	7.1% 2/28 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
General disorders Weight gain	3.3% 2/60 • Number of events 2 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/28 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/24 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/10 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.
General disorders Weight loss	31.7% 19/60 • Number of events 21 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	17.9% 5/28 • Number of events 6 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/5 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	0.00% 0/1 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	45.8% 11/24 • Number of events 13 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.	30.0% 3/10 • Number of events 4 • All-Cause Mortality was monitored/assessed, up to a maximum of 27 years. Adverse Events were monitored/assessed from the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to a maximum of 49 months. All the deaths may not be accounted for in the serious and/or other adverse event tables since these were only collected during therapy and for 30 days following completion of therapy (as pre-specified in the protocol) whereas mortality data was collected up to a maximum of 27 years.

Additional Information

Dr. Christopher J. Melani

National Cancer Institute

Phone: 240-760-6057

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place