Trial Outcomes & Findings for Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Previously Untreated Aggressive Non-Hodgkin's Lymphoma (NCT NCT00001337)

NCT ID: NCT00001337

Last Updated: 2025-06-22

Results Overview

Overall response defined as a Complete Response + Partial Response was measured by the Response Criteria. Complete Response is disappearance of all signs and symptoms of lymphoma for a period of at least one month. Partial Response is 50% or greater decrease in the sum of the products of the longest perpendicular diameters of all measured lesions lasting for a period of at least one month.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 348 participants
• Primary outcome timeframe: Time frame was from beginning of therapy until the end of therapy, an average of 6 months
• Results posted on: 2025-06-22

Participant Flow

Participant milestones

Measure	With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) Subgroup 1 (SG1) - All participants who received combination Rituximab (EPOCH-R). Rituximab 375 mg/m\^2 intravenous (IV) on day 1, every 21 days, prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.	EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide) Subgroup 2 (SG2) - EPOCH alone: All participants who received Prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.	Enrolled But Not Treated One participant was enrolled and not treated.
Overall Study STARTED	235	112	1
Overall Study Follow-up Period Completed	148	43	0
Overall Study COMPLETED	148	43	0
Overall Study NOT COMPLETED	87	69	1

Reasons for withdrawal

Measure	With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) Subgroup 1 (SG1) - All participants who received combination Rituximab (EPOCH-R). Rituximab 375 mg/m\^2 intravenous (IV) on day 1, every 21 days, prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.	EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide) Subgroup 2 (SG2) - EPOCH alone: All participants who received Prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.	Enrolled But Not Treated One participant was enrolled and not treated.
Overall Study Switched to alternate treatment	2	2	0
Overall Study Refused further treatment	2	1	0
Overall Study Began other Tx	1	0	0
Overall Study Physician Decision	3	1	0
Overall Study Doesn't have NHL	0	1	0
Overall Study Non protocol tx needed	3	1	0
Overall Study Protocol change	1	0	0
Overall Study 2nd primary disease	0	0	1
Overall Study Death during follow up period	9	4	0
Overall Study Death on study	19	9	0
Overall Study Disease progression during follow-up period	3	1	0
Overall Study Disease progression on study	33	41	0
Overall Study Lost to further follow-up	10	6	0
Overall Study 2nd malignancy	1	0	0
Overall Study Treatment for second lymphoma	0	1	0
Overall Study Transfer to transplant	0	1	0

Baseline Characteristics

Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Previously Untreated Aggressive Non-Hodgkin's Lymphoma

Baseline characteristics by cohort

Measure	With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) n=235 Participants Subgroup 1 (SG1) - All participants who received combination Rituximab (EPOCH-R). Rituximab 375 mg/m\^2 intravenous (IV) on day 1, every 21 days, prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.	EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide) n=112 Participants Subgroup 2 (SG2) - EPOCH alone: All participants who received Prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.	Enrolled But Not Treated n=1 Participants Participant was enrolled but not treated.	Total n=348 Participants Total of all reporting groups
Age, Categorical <=18 years	5 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	5 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	200 Participants n=93 Participants	102 Participants n=4 Participants	1 Participants n=27 Participants	303 Participants n=483 Participants
Age, Categorical >=65 years	30 Participants n=93 Participants	10 Participants n=4 Participants	0 Participants n=27 Participants	40 Participants n=483 Participants
Age, Continuous	43.97 years STANDARD_DEVIATION 17.7 • n=93 Participants	47.2 years STANDARD_DEVIATION 15.29 • n=4 Participants	62.6 years STANDARD_DEVIATION 0 • n=27 Participants	45.06 years STANDARD_DEVIATION 17 • n=483 Participants
Sex: Female, Male Female	103 Participants n=93 Participants	50 Participants n=4 Participants	0 Participants n=27 Participants	153 Participants n=483 Participants
Sex: Female, Male Male	132 Participants n=93 Participants	62 Participants n=4 Participants	1 Participants n=27 Participants	195 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	18 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	211 Participants n=93 Participants	108 Participants n=4 Participants	1 Participants n=27 Participants	320 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=93 Participants	3 Participants n=4 Participants	0 Participants n=27 Participants	10 Participants n=483 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
Race (NIH/OMB) Asian	12 Participants n=93 Participants	6 Participants n=4 Participants	0 Participants n=27 Participants	18 Participants n=483 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
Race (NIH/OMB) Black or African American	37 Participants n=93 Participants	13 Participants n=4 Participants	1 Participants n=27 Participants	51 Participants n=483 Participants
Race (NIH/OMB) White	169 Participants n=93 Participants	91 Participants n=4 Participants	0 Participants n=27 Participants	260 Participants n=483 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
Race (NIH/OMB) Unknown or Not Reported	17 Participants n=93 Participants	2 Participants n=4 Participants	0 Participants n=27 Participants	19 Participants n=483 Participants
Region of Enrollment United States	235 participants n=93 Participants	112 participants n=4 Participants	1 participants n=27 Participants	348 participants n=483 Participants

PRIMARY outcome

Timeframe: Time frame was from beginning of therapy until the end of therapy, an average of 6 months

Population: 347/348 participants were analyzed because 1 was inevaluable for response.

Overall response defined as a Complete Response + Partial Response was measured by the Response Criteria. Complete Response is disappearance of all signs and symptoms of lymphoma for a period of at least one month. Partial Response is 50% or greater decrease in the sum of the products of the longest perpendicular diameters of all measured lesions lasting for a period of at least one month.

Outcome measures

Measure	With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) n=235 Participants Subgroup 1 (SG1) - All participants who received combination Rituximab (EPOCH-R). Rituximab 375 mg/m\^2 intravenous (IV) on day 1, every 21 days, prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.	EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide) n=112 Participants Subgroup 2 (SG2) - EPOCH alone: All participants who received Prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.
Overall Response (Complete Response + Partial Response)	216 Participants	94 Participants

PRIMARY outcome

Timeframe: Progression free survival was calculated from study entry until progression or death from any cause. Median follow up of evaluable participants was 5 years (range 2-7 years)

Population: 347/348 participants were analyzed because 1 was inevaluable for response.

The Dixon-Simon method will be used to determine whether large B-cell lymphomas expressing BCL-2 (+) participants may experience an improved progression free survival with Etoposide, VP-16, and Doxorubicin with Prednisone, Cyclophosphamide, and Rituximab (EPOCH-R) compared to EPOCH alone, and to obtain a concurrent, precisely determined measure of progression free survival. PFS is the time from start of treatment to documented evidence of disease progression. Progression is an increase of 25% or more in the sum of the products of the longest perpendicular diameters of all measured lesions, or the appearance of any new lesions measured by the Response Criteria.

Outcome measures

Measure	With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) n=235 Participants Subgroup 1 (SG1) - All participants who received combination Rituximab (EPOCH-R). Rituximab 375 mg/m\^2 intravenous (IV) on day 1, every 21 days, prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.	EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide) n=112 Participants Subgroup 2 (SG2) - EPOCH alone: All participants who received Prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.
Progression Free Survival (PFS)	73 Participants	41 Participants

SECONDARY outcome

Timeframe: Initiation of study drug until 30 days after treatment, an average of 6 months

Population: 347/348 participants were analyzed because one participant was enrolled and not treated.

Here is the proportion of participants with adverse events leading to discontinuation of therapy. 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 participant and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Measure	With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) n=235 Participants Subgroup 1 (SG1) - All participants who received combination Rituximab (EPOCH-R). Rituximab 375 mg/m\^2 intravenous (IV) on day 1, every 21 days, prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.	EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide) n=112 Participants Subgroup 2 (SG2) - EPOCH alone: All participants who received Prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.
Proportion of Participants With Serious and/or Non-serious Adverse Events Leading to Discontinuation of Therapy	0.03 proportion of participants	0.04 proportion of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Time frame is from study entry until 30 days after completing study therapy, approximately 5 years.

Population: 347/348 participants were analyzed because one participant was enrolled and not treated.

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). 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

Measure	With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) n=235 Participants Subgroup 1 (SG1) - All participants who received combination Rituximab (EPOCH-R). Rituximab 375 mg/m\^2 intravenous (IV) on day 1, every 21 days, prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.	EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide) n=112 Participants Subgroup 2 (SG2) - EPOCH alone: All participants who received Prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)	235 Participants	112 Participants

Adverse Events

With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab)

Serious events: 146 serious events

Other events: 235 other events

Deaths: 28 deaths

EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide)

Serious events: 44 serious events

Other events: 112 other events

Deaths: 13 deaths

Serious adverse events

Measure	With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) n=235 participants at risk Subgroup 1 (SG1) - All participants who received combination Rituximab (EPOCH-R). Rituximab 375 mg/m\^2 intravenous (IV) on day 1, every 21 days, prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.	EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide) n=112 participants at risk Subgroup 2 (SG2) - EPOCH alone: All participants who received Prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.
Metabolism and nutrition disorders Acidosis (metabolic or respiratory)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Immune system disorders Allergic reaction/hypersensitivity (including drug fever)	0.85% 2/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Anorexia	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Nervous system disorders CNS cerebrovascular ischemia	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Cardiac disorders Cardiac ischemia/infarction	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Nervous system disorders Confusion	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Constipation	3.0% 7/235 • Number of events 7 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Respiratory, thoracic and mediastinal disorders Cough	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
General disorders Cytokine release syndrome/acute infusion reaction	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Dehydration	1.3% 3/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Diarrhea	2.6% 6/235 • Number of events 9 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Nervous system disorders Dizziness	1.3% 3/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	0.85% 2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Febrile neutropenia	44.3% 104/235 • Number of events 170 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	31.2% 35/112 • Number of events 53 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	4.7% 11/235 • Number of events 12 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	2.7% 3/112 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Gastrointestinal - Other (Esophageal Obstruction)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Gastrointestinal - Other (Hernia)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Blood and lymphatic system disorders Hemoglobin	1.7% 4/235 • Number of events 5 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Nervous system disorders Hemorrhage, CNS	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Hemorrhage, GI::Upper GI NOS	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory::Nose	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory::Respiratory tract NOS	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Cardiac disorders Hypotension	3.4% 8/235 • Number of events 10 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	1.8% 2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)	3.0% 7/235 • Number of events 7 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils	0.85% 2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Blood	0.00% 0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)	0.00% 0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Rectum	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection with unknown ANC::Urinary tract NOS	0.00% 0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Blood and lymphatic system disorders Leukocytes (total WBC)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Hepatobiliary disorders Liver dysfunction/failure (clinical)	0.00% 0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Metabolism and nutrition disorders Magnesium, serum-low (hypomagnesemia)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Mucositis/stomatitis (clinical exam)::Oral cavity	2.1% 5/235 • Number of events 6 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy)::Whole body/generalized	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Musculoskeletal and connective tissue disorders Musculoskeletal/Soft Tissue - Other (Hip fracture)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Nausea	2.1% 5/235 • Number of events 8 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Nervous system disorders Neurology - Other (subdural hygroma)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Nervous system disorders Neuropathy: cranial::CN VII Motor-face; Sensory-taste	0.00% 0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Nervous system disorders Neuropathy: motor	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Nervous system disorders Neuropathy: sensory	0.00% 0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Investigations Neutrophils/granulocytes (ANC/AGC)	2.1% 5/235 • Number of events 6 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	1.8% 2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Blood and lymphatic system disorders PTT (Partial Thromboplastin Time)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Skin and subcutaneous tissue disorders Pain - Other (Incision)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Pain::Abdomen NOS	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	3.6% 4/112 • Number of events 5 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Musculoskeletal and connective tissue disorders Pain::Bone	1.3% 3/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Musculoskeletal and connective tissue disorders Pain::Chest/thorax NOS	1.3% 3/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Nervous system disorders Pain::Head/headache	0.85% 2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Musculoskeletal and connective tissue disorders Pain::Muscle	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Hepatobiliary disorders Pancreatitis	0.00% 0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Perforation, GI::Duodenum	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Perforation, GI::Esophagus	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Perforation, GI::Small bowel NOS	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Perforation, GI::Stomach	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Blood and lymphatic system disorders Platelets	0.85% 2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	0.85% 2/235 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Skin and subcutaneous tissue disorders Rash: dermatitis associated with radiation::Radiation	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Renal and urinary disorders Renal failure	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
General disorders Rigors/chills	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Secondary Malignancy - possibly related to cancer treatment (Specify, __)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Cardiac disorders Supraventricular and nodal arrhythmia::Sinus arrhythmia	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Cardiac disorders Supraventricular and nodal arrhythmia::Sinus tachycardia	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Nervous system disorders Syncope (fainting)	0.85% 2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Vascular disorders Thrombosis/thrombus/embolism	2.1% 5/235 • Number of events 5 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	3.6% 4/112 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Vomiting	1.7% 4/235 • Number of events 5 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.

Other adverse events

Measure	With EPOCH-R (Etoposide, Doxorubicin, Prednisone, Cyclophosphamide and Rituximab) n=235 participants at risk Subgroup 1 (SG1) - All participants who received combination Rituximab (EPOCH-R). Rituximab 375 mg/m\^2 intravenous (IV) on day 1, every 21 days, prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.	EPOCH Alone (Etoposide, Doxorubicin, Prednisone, and Cyclophosphamide) n=112 participants at risk Subgroup 2 (SG2) - EPOCH alone: All participants who received Prednisone 100mg by mouth (PO) twice a day (bid) on days 1 through 5 every 21 days, and cyclophosphamide 750mg/m\^2 on day 5 every 21 days. Doxorubicin 10mg/m\^2/day, vincristine 0.4mg/m\^2/day, and etoposide 50mg/m\^2/day were delivered as continuous intravenous (CIV) infusions over 96 hours starting on day 1 every 21 days. Dose levels were adjusted on doxorubicin, etoposide, and cyclophosphamide each cycle based on neutrophil nadir.
Infections and infestations Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils	0.85% 2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Metabolism and nutrition disorders ALT, SGPT (serum glutamic pyruvic transaminase)	52.8% 124/235 • Number of events 210 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	17.0% 19/112 • Number of events 27 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Metabolism and nutrition disorders AST, SGOT(serum glutamic oxaloacetic transaminase)	35.3% 83/235 • Number of events 121 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	10.7% 12/112 • Number of events 17 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	54.0% 127/235 • Number of events 231 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	13.4% 15/112 • Number of events 29 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Metabolism and nutrition disorders Alkaline phosphatase	21.3% 50/235 • Number of events 72 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	12.5% 14/112 • Number of events 16 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Immune system disorders Allergic reaction/hypersensitivity (including drug fever)	8.5% 20/235 • Number of events 24 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Immune system disorders Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)	26.4% 62/235 • Number of events 74 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	10.7% 12/112 • Number of events 14 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Metabolism and nutrition disorders Amylase	1.7% 4/235 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Anorexia	31.9% 75/235 • Number of events 122 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	16.1% 18/112 • Number of events 22 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Musculoskeletal and connective tissue disorders Arthritis (non-septic)	0.85% 2/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Ear and labyrinth disorders Auditory/Ear - Other (decreased hearing)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Metabolism and nutrition disorders Bicarbonate, serum-low	6.8% 16/235 • Number of events 34 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	1.8% 2/112 • Number of events 5 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Metabolism and nutrition disorders Bilirubin (hyperbilirubinemia)	17.4% 41/235 • Number of events 62 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	6.2% 7/112 • Number of events 13 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Respiratory, thoracic and mediastinal disorders Bronchospasm, wheezing	1.3% 3/235 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Skin and subcutaneous tissue disorders Bruising (in absence of Grade 3 or 4 thrombocytopenia)	1.3% 3/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	1.8% 2/112 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Nervous system disorders CNS cerebrovascular ischemia	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Metabolism and nutrition disorders CPK (creatine phosphokinase)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Metabolism and nutrition disorders Calcium, serum-high (hypercalcemia)	4.3% 10/235 • Number of events 17 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	1.8% 2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	25.5% 60/235 • Number of events 88 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	7.1% 8/112 • Number of events 8 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Cardiac disorders Cardiac General - Other (Fluid overload)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Cardiac disorders Cardiac ischemia/infarction	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Nervous system disorders Cognitive disturbance	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Colitis, infectious (e.g., Clostridium difficile)	0.85% 2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Nervous system disorders Confusion	2.6% 6/235 • Number of events 6 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Constipation	62.1% 146/235 • Number of events 267 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	40.2% 45/112 • Number of events 65 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
General disorders Constitutional Symptoms - Other (Intolerance to cold)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Respiratory, thoracic and mediastinal disorders Cough	28.1% 66/235 • Number of events 81 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	8.9% 10/112 • Number of events 12 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Metabolism and nutrition disorders Creatinine	11.1% 26/235 • Number of events 40 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	1.8% 2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Renal and urinary disorders Cystitis	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Blood and lymphatic system disorders DIC (disseminated intravascular coagulation)	0.00% 0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Dehydration	10.2% 24/235 • Number of events 28 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	5.4% 6/112 • Number of events 6 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other (Blisters-toes)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other (Cold sore)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Diarrhea	46.0% 108/235 • Number of events 184 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	38.4% 43/112 • Number of events 71 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Distension/bloating, abdominal	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Nervous system disorders Dizziness	25.5% 60/235 • Number of events 84 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	10.7% 12/112 • Number of events 19 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Eye disorders Dry eye syndrome	5.5% 13/235 • Number of events 13 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	4.5% 5/112 • Number of events 6 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Dry mouth/salivary gland (xerostomia)	1.7% 4/235 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	1.8% 2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Skin and subcutaneous tissue disorders Dry skin	3.4% 8/235 • Number of events 8 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	1.8% 2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Dysphagia (difficulty swallowing)	4.7% 11/235 • Number of events 12 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	3.6% 4/112 • Number of events 6 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	28.9% 68/235 • Number of events 94 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	14.3% 16/112 • Number of events 24 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Blood and lymphatic system disorders Edema: limb	17.9% 42/235 • Number of events 52 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	9.8% 11/112 • Number of events 16 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Reproductive system and breast disorders Erectile dysfunction	4.3% 10/235 • Number of events 17 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	1.8% 2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Esophagitis	4.7% 11/235 • Number of events 12 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	2.7% 3/112 • Number of events 5 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Nervous system disorders Extrapyramidal/involuntary movement/restlessness	0.85% 2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
General disorders Fatigue (asthenia, lethargy, malaise)	83.0% 195/235 • Number of events 417 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	69.6% 78/112 • Number of events 179 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Febrile neutropenia	17.4% 41/235 • Number of events 52 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	9.8% 11/112 • Number of events 11 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	32.8% 77/235 • Number of events 99 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	25.9% 29/112 • Number of events 45 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Fistula, GI::Rectum	0.00% 0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Flatulence	5.1% 12/235 • Number of events 16 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Skin and subcutaneous tissue disorders Flushing	4.3% 10/235 • Number of events 11 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	1.8% 2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Metabolism and nutrition disorders GGT (gamma-Glutamyl transpeptidase)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Gastritis (including bile reflux gastritis)	1.3% 3/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Gastrointestinal - Other (Bloating)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Gastrointestinal - Other (Early satiety)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Gastrointestinal - Other (Esophageal Stenosis)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Gastrointestinal - Other (Hernia)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	43.8% 103/235 • Number of events 194 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	17.0% 19/112 • Number of events 37 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Metabolism and nutrition disorders Glucose, serum-low (hypoglycemia)	6.0% 14/235 • Number of events 17 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	3.6% 4/112 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Skin and subcutaneous tissue disorders Hair loss/alopecia (scalp or body)	59.1% 139/235 • Number of events 154 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	71.4% 80/112 • Number of events 98 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Ear and labyrinth disorders Hearing: patients with/without baseline audiogram and enrolled in a monitoring program	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Ear and labyrinth disorders Hearing: patients without baseline audiogram and not enrolled in a monitoring program	2.6% 6/235 • Number of events 7 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Heartburn/dyspepsia	23.4% 55/235 • Number of events 66 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	7.1% 8/112 • Number of events 9 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Blood and lymphatic system disorders Hemoglobin	86.0% 202/235 • Number of events 580 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	32.1% 36/112 • Number of events 107 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Hemorrhage, GI::Anus	0.85% 2/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Hemorrhage, GI::Oral cavity	0.00% 0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Hemorrhage, GI::Rectum	6.0% 14/235 • Number of events 15 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	3.6% 4/112 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Hemorrhage, GI::Upper GI NOS	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Hemorrhage, GI::Varices (rectal)	0.85% 2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Renal and urinary disorders Hemorrhage, GU::Urethra	0.43% 1/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Renal and urinary disorders Hemorrhage, GU::Urinary NOS	3.0% 7/235 • Number of events 7 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	1.8% 2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Reproductive system and breast disorders Hemorrhage, GU::Vagina	0.00% 0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	1.8% 2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory::Bronchopulmonary NOS	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory::Nose	5.5% 13/235 • Number of events 14 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	2.7% 3/112 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory::Respiratory tract NOS	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Skin and subcutaneous tissue disorders Hemorrhage/Bleeding - Other (Ecchymosis)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Musculoskeletal and connective tissue disorders Hemorrhage/Bleeding - Other (Gluteal muscle;Compartment syndrome)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Blood and lymphatic system disorders Hemorrhoids	3.0% 7/235 • Number of events 12 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Respiratory, thoracic and mediastinal disorders Hiccoughs (hiccups, singultus)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Endocrine disorders Hot flashes/flushes	2.1% 5/235 • Number of events 5 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Skin and subcutaneous tissue disorders Hyperpigmentation	4.7% 11/235 • Number of events 12 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	1.8% 2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Cardiac disorders Hypertension	2.1% 5/235 • Number of events 5 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	4.5% 5/112 • Number of events 5 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Skin and subcutaneous tissue disorders Hypopigmentation	0.00% 0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Cardiac disorders Hypotension	13.6% 32/235 • Number of events 40 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	8.0% 9/112 • Number of events 11 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.85% 2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	1.8% 2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)	2.1% 5/235 • Number of events 5 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	8.0% 9/112 • Number of events 10 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Renal and urinary disorders Incontinence, urinary	3.4% 8/235 • Number of events 8 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection - Other (PAC; blood-yeast)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection - Other (R axilla)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection - Other (foot - tinea pedis)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection - Other (fungal, tinea pedis)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Abdomen NOS	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Blood	3.0% 7/235 • Number of events 7 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Catheter-related	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	1.8% 2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Colon	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Conjunctiva	0.85% 2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::External ear (otitis externa)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Eye NOS	0.85% 2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Lip/perioral	0.85% 2/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Liver	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)	3.0% 7/235 • Number of events 8 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Middle ear (otitis media)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Mucosa	5.5% 13/235 • Number of events 15 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Nerve-peripheral	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Nose	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Rectum	3.0% 7/235 • Number of events 7 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Salivary gland	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Scrotum	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Sinus	1.7% 4/235 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	1.8% 2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)	1.3% 3/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Small bowel NOS	0.00% 0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Ungual (nails)	0.85% 2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Upper aerodigestive NOS	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS	7.7% 18/235 • Number of events 19 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	2.7% 3/112 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS	3.4% 8/235 • Number of events 8 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Vagina	0.85% 2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Wound	0.85% 2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection with unknown ANC::Blood	0.00% 0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection with unknown ANC::Conjunctiva	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection with unknown ANC::Rectum	0.00% 0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Infections and infestations Infection with unknown ANC::Urinary tract NOS	0.00% 0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Skin and subcutaneous tissue disorders Injection site reaction/extravasation changes	1.7% 4/235 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Insomnia	22.6% 53/235 • Number of events 75 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	12.5% 14/112 • Number of events 17 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Reproductive system and breast disorders Irregular menses (change from baseline)	3.0% 7/235 • Number of events 7 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Blood and lymphatic system disorders Leukocytes (total WBC)	87.2% 205/235 • Number of events 1002 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	30.4% 34/112 • Number of events 142 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Metabolism and nutrition disorders Lipase	0.85% 2/235 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Blood and lymphatic system disorders Lymphopenia	78.7% 185/235 • Number of events 676 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	26.8% 30/112 • Number of events 100 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Metabolism and nutrition disorders Magnesium, serum-high (hypermagnesemia)	23.0% 54/235 • Number of events 72 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	6.2% 7/112 • Number of events 12 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Metabolism and nutrition disorders Magnesium, serum-low (hypomagnesemia)	24.3% 57/235 • Number of events 98 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	8.0% 9/112 • Number of events 16 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Nervous system disorders Memory impairment	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	2.7% 3/112 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Nervous system disorders Mood alteration::Agitation	1.7% 4/235 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	2.7% 3/112 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Nervous system disorders Mood alteration::Anxiety	8.5% 20/235 • Number of events 31 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	5.4% 6/112 • Number of events 9 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Nervous system disorders Mood alteration::Depression	7.7% 18/235 • Number of events 32 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	4.5% 5/112 • Number of events 5 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Mucositis/stomatitis (clinical exam)::Large bowel	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Mucositis/stomatitis (clinical exam)::Larynx	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Mucositis/stomatitis (clinical exam)::Oral cavity	80.0% 188/235 • Number of events 520 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	78.6% 88/112 • Number of events 222 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Mucositis/stomatitis (clinical exam)::Stomach	1.3% 3/235 • Number of events 6 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Mucositis/stomatitis (functional/symptomatic)::Oral cavity	0.85% 2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy)::Extremity-lower	1.7% 4/235 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy)::Whole body/generalized	16.2% 38/235 • Number of events 45 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	8.9% 10/112 • Number of events 12 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Musculoskeletal and connective tissue disorders Musculoskeletal/Soft Tissue - Other (Finger injury)	0.00% 0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Musculoskeletal and connective tissue disorders Musculoskeletal/Soft Tissue - Other (Hand cramps)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Musculoskeletal and connective tissue disorders Musculoskeletal/Soft Tissue - Other (Hip fracture)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Musculoskeletal and connective tissue disorders Musculoskeletal/Soft Tissue - Other (Spasms)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Musculoskeletal and connective tissue disorders Musculoskeletal/Soft Tissue - Other (Sprain)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Skin and subcutaneous tissue disorders Nail changes	10.2% 24/235 • Number of events 27 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	2.7% 3/112 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Nausea	66.0% 155/235 • Number of events 382 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	52.7% 59/112 • Number of events 123 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Nervous system disorders Neurology - Other (antonomic neuropathy)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Nervous system disorders Neuropathy: motor	12.3% 29/235 • Number of events 34 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	16.1% 18/112 • Number of events 23 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Nervous system disorders Neuropathy: sensory	87.7% 206/235 • Number of events 301 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	78.6% 88/112 • Number of events 125 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	88.1% 207/235 • Number of events 917 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	34.8% 39/112 • Number of events 148 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Obstruction, GI::Small bowel NOS	0.00% 0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Eye disorders Ocular/Visual - Other (Red eye)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Eye disorders Ocular/Visual - Other (Uveitis)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Eye disorders Ophthalmoplegia/diplopia (double vision)	1.3% 3/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Blood and lymphatic system disorders PTT (Partial Thromboplastin Time)	18.3% 43/235 • Number of events 61 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	7.1% 8/112 • Number of events 9 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
General disorders Pain - Other (Biopsy site)	0.00% 0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Pain - Other (Epigastric)	0.00% 0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	1.8% 2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Musculoskeletal and connective tissue disorders Pain - Other (Flank)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Reproductive system and breast disorders Pain - Other (Groin)	0.00% 0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Respiratory, thoracic and mediastinal disorders Pain - Other (Lung)	0.00% 0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Musculoskeletal and connective tissue disorders Pain - Other (Ribs)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
General disorders Pain - Other (VAD site)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Pain::Abdomen NOS	26.4% 62/235 • Number of events 79 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	19.6% 22/112 • Number of events 32 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Musculoskeletal and connective tissue disorders Pain::Back	9.8% 23/235 • Number of events 34 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	7.1% 8/112 • Number of events 8 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Renal and urinary disorders Pain::Bladder	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Musculoskeletal and connective tissue disorders Pain::Bone	65.1% 153/235 • Number of events 373 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	21.4% 24/112 • Number of events 46 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Reproductive system and breast disorders Pain::Breast	0.00% 0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Musculoskeletal and connective tissue disorders Pain::Buttock	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Musculoskeletal and connective tissue disorders Pain::Chest wall	3.8% 9/235 • Number of events 11 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	1.8% 2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Musculoskeletal and connective tissue disorders Pain::Chest/thorax NOS	7.2% 17/235 • Number of events 19 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	1.8% 2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Pain::Dental/teeth/peridontal	0.85% 2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	1.8% 2/112 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Ear and labyrinth disorders Pain::External ear	1.3% 3/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Musculoskeletal and connective tissue disorders Pain::Extremity-limb	8.1% 19/235 • Number of events 21 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	6.2% 7/112 • Number of events 7 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Eye disorders Pain::Eye	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Skin and subcutaneous tissue disorders Pain::Face	4.3% 10/235 • Number of events 12 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	4.5% 5/112 • Number of events 6 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Nervous system disorders Pain::Head/headache	42.1% 99/235 • Number of events 179 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	26.8% 30/112 • Number of events 45 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Musculoskeletal and connective tissue disorders Pain::Joint	23.0% 54/235 • Number of events 105 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	25.9% 29/112 • Number of events 41 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Respiratory, thoracic and mediastinal disorders Pain::Larynx	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Ear and labyrinth disorders Pain::Middle ear	1.3% 3/235 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Musculoskeletal and connective tissue disorders Pain::Muscle	34.0% 80/235 • Number of events 125 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	25.9% 29/112 • Number of events 50 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Musculoskeletal and connective tissue disorders Pain::Neck	1.7% 4/235 • Number of events 6 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Nervous system disorders Pain::Neuralgia/peripheral nerve	2.6% 6/235 • Number of events 6 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Pain::Oral cavity	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
General disorders Pain::Pain NOS	0.85% 2/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Reproductive system and breast disorders Pain::Pelvis	1.7% 4/235 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Pain::Rectum	1.7% 4/235 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Respiratory, thoracic and mediastinal disorders Pain::Throat/pharynx/larynx	3.4% 8/235 • Number of events 9 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	5.4% 6/112 • Number of events 6 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Renal and urinary disorders Pain::Urethra	3.4% 8/235 • Number of events 8 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	2.7% 3/112 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Reproductive system and breast disorders Pain::Vagina	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Cardiac disorders Palpitations	7.2% 17/235 • Number of events 21 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	2.7% 3/112 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Cardiac disorders Pericardial effusion (non-malignant)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Blood and lymphatic system disorders Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)	0.85% 2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Vascular disorders Phlebitis (including superficial thrombosis)	3.8% 9/235 • Number of events 10 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Metabolism and nutrition disorders Phosphate, serum-low (hypophosphatemia)	16.6% 39/235 • Number of events 64 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	4.5% 5/112 • Number of events 10 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Blood and lymphatic system disorders Platelets	86.4% 203/235 • Number of events 841 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	32.1% 36/112 • Number of events 134 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	1.7% 4/235 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	0.85% 2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Metabolism and nutrition disorders Potassium, serum-high (hyperkalemia)	6.0% 14/235 • Number of events 19 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	6.2% 7/112 • Number of events 7 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	28.9% 68/235 • Number of events 130 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	8.0% 9/112 • Number of events 14 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Proctitis	2.6% 6/235 • Number of events 7 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Metabolism and nutrition disorders Proteinuria	0.85% 2/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Skin and subcutaneous tissue disorders Pruritus/itching	4.3% 10/235 • Number of events 14 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Nervous system disorders Psychosis (hallucinations/delusions)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Skin and subcutaneous tissue disorders Rash/desquamation	20.0% 47/235 • Number of events 56 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	15.2% 17/112 • Number of events 18 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Skin and subcutaneous tissue disorders Rash: acne/acneiform	0.00% 0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	1.8% 2/112 • Number of events 5 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Skin and subcutaneous tissue disorders Rash: hand-foot skin reaction	3.0% 7/235 • Number of events 9 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Renal and urinary disorders Renal failure	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Renal and urinary disorders Renal/Genitourinary - Other (Nocturia)	0.00% 0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Renal and urinary disorders Renal/Genitourinary - Other (dysuria)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
General disorders Rigors/chills	9.4% 22/235 • Number of events 23 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	4.5% 5/112 • Number of events 10 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Secondary Malignancy - possibly related to cancer treatment (Specify, __)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Nervous system disorders Seizure	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Skin and subcutaneous tissue disorders Skin breakdown/decubitus ulcer	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Metabolism and nutrition disorders Sodium, serum-high (hypernatremia)	8.1% 19/235 • Number of events 25 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	6.2% 7/112 • Number of events 12 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	37.0% 87/235 • Number of events 143 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	8.9% 10/112 • Number of events 13 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Nervous system disorders Somnolence/depressed level of consciousness	0.85% 2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Nervous system disorders Speech impairment (e.g., dysphasia or aphasia)	0.00% 0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Cardiac disorders Supraventricular and nodal arrhythmia::Atrial fibrillation	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Cardiac disorders Supraventricular and nodal arrhythmia::Sinus arrhythmia	0.85% 2/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Cardiac disorders Supraventricular and nodal arrhythmia::Sinus bradycardia	1.3% 3/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Cardiac disorders Supraventricular and nodal arrhythmia::Sinus tachycardia	10.6% 25/235 • Number of events 32 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	3.6% 4/112 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Cardiac disorders Supraventricular and nodal arrhythmia::Supraventricular arrhythmia NOS	0.85% 2/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
General disorders Sweating (diaphoresis)	6.4% 15/235 • Number of events 17 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	4.5% 5/112 • Number of events 7 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Nervous system disorders Syncope (fainting)	5.1% 12/235 • Number of events 12 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Nervous system disorders Syndromes - Other (Akathisia)	0.00% 0/235 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Taste alteration (dysgeusia)	32.3% 76/235 • Number of events 127 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	8.0% 9/112 • Number of events 12 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Vascular disorders Thrombosis/embolism (vascular access-related)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Vascular disorders Thrombosis/thrombus/embolism	10.2% 24/235 • Number of events 26 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	7.1% 8/112 • Number of events 9 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Ear and labyrinth disorders Tinnitus	2.1% 5/235 • Number of events 6 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
General disorders Tumor lysis syndrome	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Metabolism and nutrition disorders Uric acid, serum-high (hyperuricemia)	2.6% 6/235 • Number of events 7 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Renal and urinary disorders Urinary frequency/urgency	5.1% 12/235 • Number of events 15 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	2.7% 3/112 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Renal and urinary disorders Urinary retention (including neurogenic bladder)	1.3% 3/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Renal and urinary disorders Urine color change	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Skin and subcutaneous tissue disorders Urticaria (hives, welts, wheals)	0.43% 1/235 • Number of events 2 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Reproductive system and breast disorders Vaginal discharge (non-infectious)	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Cardiac disorders Vasovagal episode	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Cardiac disorders Ventricular arrhythmia::Ventricular arrhythmia NOS	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Eye disorders Vision-blurred vision	9.4% 22/235 • Number of events 28 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	4.5% 5/112 • Number of events 6 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Eye disorders Vision-flashing lights/floaters	0.43% 1/235 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Eye disorders Vision-photophobia	1.7% 4/235 • Number of events 4 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Respiratory, thoracic and mediastinal disorders Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)	6.0% 14/235 • Number of events 14 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.89% 1/112 • Number of events 1 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Gastrointestinal disorders Vomiting	39.1% 92/235 • Number of events 147 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	27.7% 31/112 • Number of events 54 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
Eye disorders Watery eye (epiphora, tearing)	11.1% 26/235 • Number of events 27 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	2.7% 3/112 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
General disorders Weight gain	1.3% 3/235 • Number of events 3 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	0.00% 0/112 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.
General disorders Weight loss	8.9% 21/235 • Number of events 22 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.	9.8% 11/112 • Number of events 13 • All-cause mortality and adverse events were monitored/assessed from the first study intervention, Study Day 1, through 30 days after the last study intervention was administered, approximately 5 years. 347/348 participants were analyzed because one participant was enrolled and not treated.

Additional Information

Dr. Mark J. Roschewski

National Cancer Institute

Phone: 240-760-6183

Email: mark.roschewski@nih.gov

Results disclosure agreements

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