Trial Outcomes & Findings for Rituximab, Bendamustine Hydrochloride, and Bortezomib Followed by Rituximab and Lenalidomide in Treating Older Patients With Previously Untreated Mantle Cell Lymphoma (NCT NCT01415752)

NCT ID: NCT01415752

Last Updated: 2025-04-08

Results Overview

PFS is defined as time from randomization to lymphoma progression or death. Progression is defined as: * Appearance of any new lesion \>1.5 cm in any axis during or at the end of therapy * \>=50% increase from nadir in the sum of products of the diameters (SPD) of any previously involved nodes or extranodal masses, or in a single involved node or extranodal mass, or the size of other lesions. * \>=50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis. * Lesions should be PET positive if observed in a typical FDG-avid lymphoma or the lesion was PET positive before therapy unless the lesion is too small to be detected with current PET systems

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 373 participants
• Primary outcome timeframe: Assessed at baseline, every 3 months for 2.5 years, every 6 months up to 10 years from end of treatment, and then annually up to 10 years and 6 months
• Results posted on: 2025-04-08

Participant Flow

From 2012 to 2016, 373 patients were enrolled in this trial.

Participant milestones

Measure	Induction: Bendamustine + Rituximab Then Maintenance: Rituximab Patients receive induction therapy comprising rituximab IV on day 1 and bendamustine hydrochloride IV over 60 minutes on days 1-2. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment. Patients receive maintenance therapy comprising rituximab IV on day 1. Courses repeat every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.	Induction: Bendamustine + Rituximab + Bortezomib Then Maintenance: Rituximab Patients receive induction therapy comprising rituximab IV on day 1, bendamustine hydrochloride IV over 60 minutes on days 1-2 and bortezomib IV subcutaneously (SC) on days 1 and 8. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment. Patients receive maintenance therapy comprising rituximab IV on day 1. Courses repeat every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.	Induction: Bendamustine + Rituximab Then Maintenance: Lenalidomide + Rituximab Patients receive induction therapy comprising rituximab IV on day 1 and bendamustine hydrochloride IV over 60 minutes on days 1-2. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment. Patients then proceed to maintenance treatment. Patients receive maintenance therapy comprising lenalidomide orally (PO) daily on days 1-21 every 4 weeks and rituximab IV every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.	Induction: Bendamustine + Rituximab + Bortezomib Then Maintenance: Lenalidomide + Rituximab Patients receive induction therapy comprising rituximab IV on day 1, bendamustine hydrochloride IV over 60 minutes on days 1-2 and bortezomib IV subcutaneously (SC) on days 1 and 8. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment. Patients receive maintenance therapy comprising lenalidomide orally (PO) daily on days 1-21 every 4 weeks and rituximab IV every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Induction (Step 1) STARTED	94	93	93	93
Induction (Step 1) Included in the Analysis of Adverse Events	93	92	93	92
Induction (Step 1) Included in the Efficacy Analysis	90	90	89	89
Induction (Step 1) COMPLETED	90	90	89	89
Induction (Step 1) NOT COMPLETED	4	3	4	4
Maintenance (Step 2) STARTED	75	68	76	74
Maintenance (Step 2) Included in the Analysis of Adverse Events	74	68	73	73
Maintenance (Step 2) Included in the Efficacy Analysis	70	66	69	71
Maintenance (Step 2) COMPLETED	48	43	43	52
Maintenance (Step 2) NOT COMPLETED	27	25	33	22

Reasons for withdrawal

Measure	Induction: Bendamustine + Rituximab Then Maintenance: Rituximab Patients receive induction therapy comprising rituximab IV on day 1 and bendamustine hydrochloride IV over 60 minutes on days 1-2. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment. Patients receive maintenance therapy comprising rituximab IV on day 1. Courses repeat every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.	Induction: Bendamustine + Rituximab + Bortezomib Then Maintenance: Rituximab Patients receive induction therapy comprising rituximab IV on day 1, bendamustine hydrochloride IV over 60 minutes on days 1-2 and bortezomib IV subcutaneously (SC) on days 1 and 8. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment. Patients receive maintenance therapy comprising rituximab IV on day 1. Courses repeat every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.	Induction: Bendamustine + Rituximab Then Maintenance: Lenalidomide + Rituximab Patients receive induction therapy comprising rituximab IV on day 1 and bendamustine hydrochloride IV over 60 minutes on days 1-2. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment. Patients then proceed to maintenance treatment. Patients receive maintenance therapy comprising lenalidomide orally (PO) daily on days 1-21 every 4 weeks and rituximab IV every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.	Induction: Bendamustine + Rituximab + Bortezomib Then Maintenance: Lenalidomide + Rituximab Patients receive induction therapy comprising rituximab IV on day 1, bendamustine hydrochloride IV over 60 minutes on days 1-2 and bortezomib IV subcutaneously (SC) on days 1 and 8. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment. Patients receive maintenance therapy comprising lenalidomide orally (PO) daily on days 1-21 every 4 weeks and rituximab IV every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Induction (Step 1) Ineligible	4	3	4	4
Maintenance (Step 2) Lack of Efficacy	12	10	8	3
Maintenance (Step 2) Adverse Event	3	4	9	6
Maintenance (Step 2) Death	1	1	2	0
Maintenance (Step 2) Withdrawal by Subject	2	1	3	3
Maintenance (Step 2) Alternative therapy	0	1	0	0
Maintenance (Step 2) Other reasons	3	6	4	6
Maintenance (Step 2) Did not receive treatment	1	0	2	1
Maintenance (Step 2) ineligible	1	1	1	0
Maintenance (Step 2) Missing	4	1	4	3

Baseline Characteristics

Rituximab, Bendamustine Hydrochloride, and Bortezomib Followed by Rituximab and Lenalidomide in Treating Older Patients With Previously Untreated Mantle Cell Lymphoma

Baseline characteristics by cohort

Measure	Induction: Bendamustine + Rituximab Then Maintenance: Rituximab n=94 Participants Patients receive induction therapy comprising rituximab IV on day 1 and bendamustine hydrochloride IV over 60 minutes on days 1-2. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment. Patients receive maintenance therapy comprising rituximab IV on day 1. Courses repeat every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.	Induction: Bendamustine + Rituximab + Bortezomib Then Maintenance: Rituximab n=93 Participants Patients receive induction therapy comprising rituximab IV on day 1, bendamustine hydrochloride IV over 60 minutes on days 1-2 and bortezomib IV subcutaneously (SC) on days 1 and 8. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment. Patients receive maintenance therapy comprising rituximab IV on day 1. Courses repeat every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.	Induction: Bendamustine + Rituximab Then Maintenance: Lenalidomide + Rituximab n=93 Participants Patients receive induction therapy comprising rituximab IV on day 1 and bendamustine hydrochloride IV over 60 minutes on days 1-2. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment. Patients then proceed to maintenance treatment. Patients receive maintenance therapy comprising lenalidomide orally (PO) daily on days 1-21 every 4 weeks and rituximab IV every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.	Induction: Bendamustine + Rituximab + Bortezomib Then Maintenance: Lenalidomide + Rituximab n=93 Participants Patients receive induction therapy comprising rituximab IV on day 1, bendamustine hydrochloride IV over 60 minutes on days 1-2 and bortezomib IV subcutaneously (SC) on days 1 and 8. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment. Patients receive maintenance therapy comprising lenalidomide orally (PO) daily on days 1-21 every 4 weeks and rituximab IV every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.	Total n=373 Participants Total of all reporting groups
Age, Continuous	67 years n=93 Participants	69 years n=4 Participants	68 years n=27 Participants	66 years n=483 Participants	67 years n=36 Participants
Sex: Female, Male Female	26 Participants n=93 Participants	26 Participants n=4 Participants	25 Participants n=27 Participants	21 Participants n=483 Participants	98 Participants n=36 Participants
Sex: Female, Male Male	68 Participants n=93 Participants	67 Participants n=4 Participants	68 Participants n=27 Participants	72 Participants n=483 Participants	275 Participants n=36 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants	1 Participants n=483 Participants	7 Participants n=36 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	89 Participants n=93 Participants	90 Participants n=4 Participants	88 Participants n=27 Participants	91 Participants n=483 Participants	358 Participants n=36 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants	1 Participants n=483 Participants	8 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	1 Participants n=36 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants	1 Participants n=483 Participants	8 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	1 Participants n=36 Participants
Race (NIH/OMB) Black or African American	3 Participants n=93 Participants	2 Participants n=4 Participants	0 Participants n=27 Participants	4 Participants n=483 Participants	9 Participants n=36 Participants
Race (NIH/OMB) White	86 Participants n=93 Participants	88 Participants n=4 Participants	85 Participants n=27 Participants	84 Participants n=483 Participants	343 Participants n=36 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=93 Participants	0 Participants n=4 Participants	4 Participants n=27 Participants	2 Participants n=483 Participants	10 Participants n=36 Participants

PRIMARY outcome

Timeframe: Assessed at baseline, every 3 months for 2.5 years, every 6 months up to 10 years from end of treatment, and then annually up to 10 years and 6 months

Population: Eligible and treated patients at Step 1 (induction)

PFS is defined as time from randomization to lymphoma progression or death. Progression is defined as:

• Appearance of any new lesion >1.5 cm in any axis during or at the end of therapy
• >=50% increase from nadir in the sum of products of the diameters (SPD) of any previously involved nodes or extranodal masses, or in a single involved node or extranodal mass, or the size of other lesions.
• >=50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis.
• Lesions should be PET positive if observed in a typical FDG-avid lymphoma or the lesion was PET positive before therapy unless the lesion is too small to be detected with current PET systems

Outcome measures

Measure	Induction: Bendamustine + Rituximab (RB; Arms A + C) n=179 Participants Patients receive induction therapy comprising rituximab IV on day 1 and bendamustine hydrochloride IV over 60 minutes on days 1-2. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment.	Induction: Bendamustine + Rituximab + Bortezomib (RBV; Arms B + D) n=179 Participants Patients receive induction therapy comprising rituximab IV on day 1, bendamustine hydrochloride IV over 60 minutes on days 1-2 and bortezomib IV subcutaneously (SC) on days 1 and 8. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment.	Induction: (C) Bendamustine + Rituximab Then Maintenance: (G) Lenalidomide + Rituximab Patients receive induction therapy comprising rituximab IV on day 1 and bendamustine hydrochloride IV over 60 minutes on days 1-2. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment. Patients then proceed to maintenance treatment. Patients receive maintenance therapy comprising lenalidomide orally (PO) daily on days 1-21 every 4 weeks and rituximab IV every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity. rituximab: Given IV Bendamustine: Given IV lenalidomide: Given PO	Induction: (D) Bendamustine + Rituximab + Bortezomib Then Maintenance: (H) Lenalidomide + Rituximab Patients receive induction therapy comprising rituximab IV on day 1, bendamustine hydrochloride IV over 60 minutes on days 1-2 and bortezomib IV subcutaneously (SC) on days 1 and 8. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment. Patients receive maintenance therapy comprising lenalidomide orally (PO) daily on days 1-21 every 4 weeks and rituximab IV every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity. rituximab: Given IV Bendamustine: Given IV bortezomib: Given IV or SC lenalidomide: Given PO
Progression-free Survival (PFS) for Induction Phase	5.5 years Interval 4.5 to 6.6	6.4 years Interval 4.8 to 7.7	—	—

PRIMARY outcome

Timeframe: Assessed at registration to step 2, cycles 6, 12, 18, treatment completion, then every 3 months for 2.5 years, every 6 months up to 10 years from end of treatment, and then annually up to 10 years and 6 months

Population: Eligible and treated patients at Step 2 (maintenance)

PFS is defined as time from Step 2 registration to lymphoma progression or death. Progression is defined as:

• Appearance of any new lesion >1.5 cm in any axis during or at the end of therapy
• >=50% increase from nadir in the sum of products of the diameters (SPD) of any previously involved nodes or extranodal masses, or in a single involved node or extranodal mass, or the size of other lesions.
• >=50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis.
• Lesions should be PET positive if observed in a typical FDG-avid lymphoma or the lesion was PET positive before therapy unless the lesion is too small to be detected with current PET systems

Outcome measures

Measure	Induction: Bendamustine + Rituximab (RB; Arms A + C) n=136 Participants Patients receive induction therapy comprising rituximab IV on day 1 and bendamustine hydrochloride IV over 60 minutes on days 1-2. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment.	Induction: Bendamustine + Rituximab + Bortezomib (RBV; Arms B + D) n=140 Participants Patients receive induction therapy comprising rituximab IV on day 1, bendamustine hydrochloride IV over 60 minutes on days 1-2 and bortezomib IV subcutaneously (SC) on days 1 and 8. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment.	Induction: (C) Bendamustine + Rituximab Then Maintenance: (G) Lenalidomide + Rituximab Patients receive induction therapy comprising rituximab IV on day 1 and bendamustine hydrochloride IV over 60 minutes on days 1-2. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment. Patients then proceed to maintenance treatment. Patients receive maintenance therapy comprising lenalidomide orally (PO) daily on days 1-21 every 4 weeks and rituximab IV every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity. rituximab: Given IV Bendamustine: Given IV lenalidomide: Given PO	Induction: (D) Bendamustine + Rituximab + Bortezomib Then Maintenance: (H) Lenalidomide + Rituximab Patients receive induction therapy comprising rituximab IV on day 1, bendamustine hydrochloride IV over 60 minutes on days 1-2 and bortezomib IV subcutaneously (SC) on days 1 and 8. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment. Patients receive maintenance therapy comprising lenalidomide orally (PO) daily on days 1-21 every 4 weeks and rituximab IV every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity. rituximab: Given IV Bendamustine: Given IV bortezomib: Given IV or SC lenalidomide: Given PO
Progression-free Survival (PFS) for Maintenance Phase (Step 2)	5.9 years Interval 5.0 to 8.2	7.2 years Interval 5.5 to 7.8	—	—

SECONDARY outcome

Timeframe: Assessed at baseline and 24 weeks (end of cycle 6)

Population: Eligible and treated patients at Step 1 (induction)

Objective response is defined as either complete response (CR) or partial response (PR).

CR is defined as disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy.

PR is defined as:

• ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or extranodal masses
• No increase in the size of other nodes, liver or spleen.
• Bone marrow assessment is irrelevant for determination of a PR if the sample was positive prior to treatment. However, if positive, the cell type should be specified, e.g. large-cell lymphoma or small cleaved cell lymphoma.
• No new sites of disease.
• Patients who achieve a CR but have persistent morphologic bone marrow involvement will be considered partial responders.
• When the bone marrow was involved before therapy and a clinical CR was achieved, but with no bone marrow assessment after treatment, patients are considered partial responders.

Outcome measures

Measure	Induction: Bendamustine + Rituximab (RB; Arms A + C) n=179 Participants Patients receive induction therapy comprising rituximab IV on day 1 and bendamustine hydrochloride IV over 60 minutes on days 1-2. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment.	Induction: Bendamustine + Rituximab + Bortezomib (RBV; Arms B + D) n=179 Participants Patients receive induction therapy comprising rituximab IV on day 1, bendamustine hydrochloride IV over 60 minutes on days 1-2 and bortezomib IV subcutaneously (SC) on days 1 and 8. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment.	Induction: (C) Bendamustine + Rituximab Then Maintenance: (G) Lenalidomide + Rituximab Patients receive induction therapy comprising rituximab IV on day 1 and bendamustine hydrochloride IV over 60 minutes on days 1-2. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment. Patients then proceed to maintenance treatment. Patients receive maintenance therapy comprising lenalidomide orally (PO) daily on days 1-21 every 4 weeks and rituximab IV every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity. rituximab: Given IV Bendamustine: Given IV lenalidomide: Given PO	Induction: (D) Bendamustine + Rituximab + Bortezomib Then Maintenance: (H) Lenalidomide + Rituximab Patients receive induction therapy comprising rituximab IV on day 1, bendamustine hydrochloride IV over 60 minutes on days 1-2 and bortezomib IV subcutaneously (SC) on days 1 and 8. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment. Patients receive maintenance therapy comprising lenalidomide orally (PO) daily on days 1-21 every 4 weeks and rituximab IV every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity. rituximab: Given IV Bendamustine: Given IV bortezomib: Given IV or SC lenalidomide: Given PO
Objective Response for Induction Phase (Step 1) Objective response	158 Participants	158 Participants	—	—
Objective Response for Induction Phase (Step 1) No objective response	21 Participants	21 Participants	—	—

SECONDARY outcome

Timeframe: Assessed at baseline and 24 weeks (end of cycle 6)

Complete response is defined as disappearance of all detectable clinical evidence of disease.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Assessed every 3 months for 2.5 years, every 6 months for years 2.5-5

Population: Eligible and treated patients for the maintenance phase (Step 2)

OS is defined as the time from registration of Step 2 (maintenance) until death from any cause or last know alive. The Kaplan-Meier estimate of 5-year OS rate is reported.

Outcome measures

Measure	Induction: Bendamustine + Rituximab (RB; Arms A + C) n=70 Participants Patients receive induction therapy comprising rituximab IV on day 1 and bendamustine hydrochloride IV over 60 minutes on days 1-2. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment.	Induction: Bendamustine + Rituximab + Bortezomib (RBV; Arms B + D) n=66 Participants Patients receive induction therapy comprising rituximab IV on day 1, bendamustine hydrochloride IV over 60 minutes on days 1-2 and bortezomib IV subcutaneously (SC) on days 1 and 8. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment.	Induction: (C) Bendamustine + Rituximab Then Maintenance: (G) Lenalidomide + Rituximab n=69 Participants Patients receive induction therapy comprising rituximab IV on day 1 and bendamustine hydrochloride IV over 60 minutes on days 1-2. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment. Patients then proceed to maintenance treatment. Patients receive maintenance therapy comprising lenalidomide orally (PO) daily on days 1-21 every 4 weeks and rituximab IV every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity. rituximab: Given IV Bendamustine: Given IV lenalidomide: Given PO	Induction: (D) Bendamustine + Rituximab + Bortezomib Then Maintenance: (H) Lenalidomide + Rituximab n=71 Participants Patients receive induction therapy comprising rituximab IV on day 1, bendamustine hydrochloride IV over 60 minutes on days 1-2 and bortezomib IV subcutaneously (SC) on days 1 and 8. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment. Patients receive maintenance therapy comprising lenalidomide orally (PO) daily on days 1-21 every 4 weeks and rituximab IV every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity. rituximab: Given IV Bendamustine: Given IV bortezomib: Given IV or SC lenalidomide: Given PO
Overall Survival (OS) Rate at 5 Years Since Maintenance (Step 2)	0.866 Proportion of participants Interval 0.758 to 0.928	0.828 Proportion of participants Interval 0.711 to 0.901	0.727 Proportion of participants Interval 0.602 to 0.819	0.853 Proportion of participants Interval 0.743 to 0.918

SECONDARY outcome

Timeframe: Assessed at baseline and every 4 months for 2 years

Objective response is defined as either complete response (CR) or partial response (PR).

CR is defined as disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy.

PR is defined as:

• ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or extranodal masses
• No increase in the size of other nodes, liver or spleen.
• Bone marrow assessment is irrelevant for determination of a PR if the sample was positive prior to treatment. However, if positive, the cell type should be specified, e.g. large-cell lymphoma or small cleaved cell lymphoma.
• No new sites of disease.
• Patients who achieve a CR but have persistent morphologic bone marrow involvement will be considered partial responders.
• When the bone marrow was involved before therapy and a clinical CR was achieved, but with no bone marrow assessment after treatment, patients are considered partial responders.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed at baseline

Collection of paraffin embedded tissue for creation of tissue microarray

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed at baseline, end of cycle 3, end of cycle 6, every 4 months during first year of maintenance, every 6 months during 2nd year of maintenance, and 12 months after completion of maintenance

Collecting and banking serum and blood mononuclear cells for future studies

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed at baseline

Collection of formalin fixed paraffin embedded (FFPE) tissue for future analysis of potential prognostic factors

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed at baseline, 6, 12, 30, 36, 48 and 60 months

FACT/GOG-Ntx subscale has 11 items and the score ranges from 0 to 44. The higher the score, the better the quality of life.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed at baseline, 6, 12, 30, 36, 48 and 60 months

FACIT-Fatigue scale has 14 items and the score ranges from 0 to 56. The higher the score, the better the quality of life.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed at baseline, 6, 12, 30, 36, 48 and 60 months

FACT-G subscale has 27 items and the score ranges from 0 to 108. The higher the score, the better the quality of life.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed at baseline, 6, 12, 30, 36, 48 and 60 months

FACT/GOG-Ntx subscale has 11 items and the score ranges from 0 to 44. FACT-G has 27 items and the score ranges from 0 to 108. The higher the score, the better the quality of life for both scales.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed at baseline, 6, 12, 30, 36, 48 and 60 months

FACT-Lymphoma has 15 items and the score ranges from 0 to 60. The higher the score, the better the quality of life.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed at baseline, 6, 12, 30, 36, 48 and 60 months

FACT-Lymphoma has 15 items and the score ranges from 0 to 60. The higher the score, the better the quality of life.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed at baseline, 6, 12, 30, 36, 48 and 60 months

The overall health-related quality of life is evaluated using FACT-G. FACT-G subscale has 27 items and the score ranges from 0 to 108. The higher the score, the better the quality of life.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed at baseline and every 4 months for 2 years and every 6 months for years 3-10 and then annually up to 15 years

Assessment of the proportion of patients up and down staging when FDGPET/CT is added to standard Ann Arbor staging will be performed.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed at baseline and every 4 months for 2 years and every 6 months for years 3-10 and then annually up to 15 years

To assess the ability of pre-treatment FDG-PET/CT semi quantitative parameters including SUVmax and metabolic measurements to predict response rate and PFS.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed at baseline and every 4 months for 2 years and every 6 months for years 3-10 and then annually up to 15 years

Among patients with interim FDG-PET/CT imaging, to assess the correlation of interim FDG-PET/CT imaging with response rate and PFS both during induction and consolidation therapy.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed at baseline and every 4 months for 2 years and every 6 months for years 3-10 and then annually up to 15 years

To assess standard FDG-PET/CT metrics including SUVmax, tumor metabolic burden, total tumor burden, and association with pathology features (blastoid variant vs. other, and Ki67) in the setting of MCL.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed at baseline and every 4 months for 2 years

To assess differences in overall and complete response rates when using Deauville vs. International Harmonization Project FDG-PET/CT interpretation criteria.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed at baseline and every 4 months for 2 years and every 6 months for years 3-10 and then annually up to 15 years

To determine whether there is a correlation between FDG-PET/CT response and residual disease assessment by molecular and/or flow cytometric techniques

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed at baseline and end of cycle 6

To determine whether the number of malignant cells in circulation predict the number of cells in marrow

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed at baseline and every 4 months for 2 years

To determine whether the number of malignant cells in circulation/in marrow at the end of induction correlate with CR and 2 year PFS

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed at baseline, end of cycles 3 and 6, every 4 months during 1st year of maintenance, every 6 months during 2nd year of maintenance and 12 months after completion of maintenance

Minimal residual disease (MRD) will be evaluated using blood samples and bone marrow samples collected on this study.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed at baseline, end of cycles 3 and 6, every 4 months during 1st year of maintenance, every 6 months during 2nd year of maintenance and 12 months after completion of maintenance

MRD levels will be evaluated using two different methods, molecular techniques and flow cytometry. The difference in MRD levels between the two methods will be assessed.

Outcome measures

Outcome data not reported

Adverse Events

Induction: Bendamustine + Rituximab (Arm A)

Serious events: 75 serious events

Other events: 92 other events

Deaths: 11 deaths

Induction: Bendamustine + Rituximab + Bortezomib (Arm B)

Serious events: 80 serious events

Other events: 88 other events

Deaths: 16 deaths

Induction: Bendamustine + Rituximab (Arm C)

Serious events: 70 serious events

Other events: 93 other events

Deaths: 11 deaths

Induction: Bendamustine + Rituximab + Bortezomib (Arm D)

Serious events: 83 serious events

Other events: 92 other events

Deaths: 11 deaths

Maintenance: Rituximab (Arm E)

Serious events: 50 serious events

Other events: 71 other events

Deaths: 22 deaths

Maintenance: Rituximab (Arm F)

Serious events: 41 serious events

Other events: 64 other events

Deaths: 20 deaths

Maintenance: Lenalidomide + Rituximab (Arm G)

Serious events: 62 serious events

Other events: 73 other events

Deaths: 26 deaths

Maintenance: Lenalidomide + Rituximab (Arm H)

Serious events: 65 serious events

Other events: 73 other events

Deaths: 17 deaths

Serious adverse events

Measure	Induction: Bendamustine + Rituximab (Arm A) n=93 participants at risk Patients receive induction therapy comprising rituximab IV on day 1 and bendamustine hydrochloride IV over 60 minutes on days 1-2. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment.	Induction: Bendamustine + Rituximab + Bortezomib (Arm B) n=92 participants at risk Patients receive induction therapy comprising rituximab IV on day 1, bendamustine hydrochloride IV over 60 minutes on days 1-2 and bortezomib IV subcutaneously (SC) on days 1 and 8. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment.	Induction: Bendamustine + Rituximab (Arm C) n=93 participants at risk Patients receive induction therapy comprising rituximab IV on day 1 and bendamustine hydrochloride IV over 60 minutes on days 1-2. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment.	Induction: Bendamustine + Rituximab + Bortezomib (Arm D) n=92 participants at risk Patients receive induction therapy comprising rituximab IV on day 1, bendamustine hydrochloride IV over 60 minutes on days 1-2 and bortezomib IV subcutaneously (SC) on days 1 and 8. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment.	Maintenance: Rituximab (Arm E) n=74 participants at risk Patients receive maintenance therapy comprising rituximab IV on day 1. Courses repeat every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.	Maintenance: Rituximab (Arm F) n=68 participants at risk Patients receive maintenance therapy comprising rituximab IV on day 1. Courses repeat every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.	Maintenance: Lenalidomide + Rituximab (Arm G) n=73 participants at risk Patients receive maintenance therapy comprising lenalidomide orally (PO) daily on days 1-21 every 4 weeks and rituximab IV every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.	Maintenance: Lenalidomide + Rituximab (Arm H) n=73 participants at risk Patients receive maintenance therapy comprising lenalidomide orally (PO) daily on days 1-21 every 4 weeks and rituximab IV every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Nervous system disorders Syncope	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.7% 2/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Immune system disorders Immune system disorders - Other, specify	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Infections and infestations Appendicitis perforated	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Blood and lymphatic system disorders Anemia	4.3% 4/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.2% 2/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	4.3% 4/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	5.4% 5/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.5% 1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Blood and lymphatic system disorders Febrile neutropenia	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.2% 2/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	4.3% 4/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	4.3% 4/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	5.9% 4/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	6.8% 5/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	6.8% 5/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Cardiac disorders Atrial fibrillation	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.2% 2/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Cardiac disorders Atrial flutter	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Cardiac disorders Cardiac arrest	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Cardiac disorders Left ventricular systolic dysfunction	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Cardiac disorders Myocardial infarction	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
General disorders Edema limbs	3.2% 3/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.2% 2/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
General disorders Fatigue	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.2% 2/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	3.3% 3/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.5% 1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	4.1% 3/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	6.8% 5/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
General disorders Fever	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.2% 2/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
General disorders Infusion related reaction	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	3.3% 3/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.2% 2/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
General disorders Pain	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
General disorders General disorders and administration site conditions - Other, specify	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Skin and subcutaneous tissue disorders Pruritus	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.2% 2/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Skin and subcutaneous tissue disorders Rash acneiform	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Skin and subcutaneous tissue disorders Rash maculo-papular	5.4% 5/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	6.5% 6/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.2% 2/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	5.4% 5/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	4.1% 3/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Gastrointestinal disorders Abdominal distension	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Gastrointestinal disorders Abdominal pain	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Gastrointestinal disorders Colitis	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.5% 1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Gastrointestinal disorders Dental caries	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Gastrointestinal disorders Diarrhea	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	3.3% 3/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.2% 2/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.5% 1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	5.5% 4/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Gastrointestinal disorders Mucositis oral	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Gastrointestinal disorders Nausea	2.2% 2/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Gastrointestinal disorders Vomiting	2.2% 2/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.2% 2/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Hepatobiliary disorders Portal hypertension	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.5% 1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Immune system disorders Allergic reaction	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	4.3% 4/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.2% 2/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Immune system disorders Anaphylaxis	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Immune system disorders Cytokine release syndrome	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Infections and infestations Eye infection	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Infections and infestations Lung infection	2.2% 2/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.2% 2/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.2% 2/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	4.1% 3/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.5% 1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	6.8% 5/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	9.6% 7/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Infections and infestations Sepsis	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.2% 2/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	4.1% 3/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Infections and infestations Sinusitis	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Infections and infestations Skin infection	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.7% 2/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Infections and infestations Tooth infection	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Infections and infestations Upper respiratory infection	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.7% 2/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Infections and infestations Urinary tract infection	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.5% 1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Infections and infestations Infections and infestations - Other, specify	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	3.3% 3/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.2% 2/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.7% 2/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.9% 2/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Investigations Alanine aminotransferase increased	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Investigations Aspartate aminotransferase increased	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Investigations CD4 lymphocytes decreased	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Investigations CPK increased	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.5% 1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Investigations Creatinine increased	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.5% 1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Investigations GGT increased	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.5% 1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Investigations INR increased	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Investigations Lymphocyte count decreased	59.1% 55/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	63.0% 58/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	63.4% 59/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	75.0% 69/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	51.4% 38/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	51.5% 35/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	49.3% 36/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	65.8% 48/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Investigations Lymphocyte count increased	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Investigations Neutrophil count decreased	22.6% 21/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	26.1% 24/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	19.4% 18/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	30.4% 28/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	21.6% 16/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	17.6% 12/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	60.3% 44/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	57.5% 42/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Investigations Platelet count decreased	6.5% 6/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	10.9% 10/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	10.8% 10/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	8.7% 8/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.5% 1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.7% 2/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.7% 2/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Investigations Weight gain	2.2% 2/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Investigations Weight loss	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.7% 2/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Investigations White blood cell decreased	15.1% 14/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	20.7% 19/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	15.1% 14/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	25.0% 23/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	14.9% 11/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	13.2% 9/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	42.5% 31/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	39.7% 29/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Metabolism and nutrition disorders Anorexia	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.5% 1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Metabolism and nutrition disorders Dehydration	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.5% 1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.5% 1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.7% 2/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Metabolism and nutrition disorders Hyperuricemia	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.2% 2/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Metabolism and nutrition disorders Hypokalemia	3.2% 3/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.5% 1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Metabolism and nutrition disorders Hyponatremia	2.2% 2/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.2% 2/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.5% 1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Metabolism and nutrition disorders Tumor lysis syndrome	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.2% 2/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	3.3% 3/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.5% 1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Musculoskeletal and connective tissue disorders Myalgia	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Nervous system disorders Dizziness	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Nervous system disorders Headache	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Nervous system disorders Neuralgia	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Nervous system disorders Paresthesia	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.7% 2/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	3.3% 3/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	3.3% 3/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.5% 1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.7% 2/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Nervous system disorders Vasovagal reaction	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukemia secondary to oncology chemotherapy	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Treatment related secondary malignancy	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	4.1% 3/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) -	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Eye disorders Cataract	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Psychiatric disorders Confusion	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Psychiatric disorders Insomnia	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.2% 2/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.7% 2/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Renal and urinary disorders Acute kidney injury	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Renal and urinary disorders Chronic kidney disease	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.5% 1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Vascular disorders Flushing	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Vascular disorders Hypertension	3.2% 3/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	7.6% 7/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	3.2% 3/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	3.3% 3/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	4.1% 3/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	4.4% 3/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.7% 2/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	4.1% 3/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Vascular disorders Hypotension	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.2% 2/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.2% 2/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.2% 2/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.5% 1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Vascular disorders Thromboembolic event	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	4.1% 3/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Vascular disorders Vascular disorders - Other, specify	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.

Other adverse events

Measure	Induction: Bendamustine + Rituximab (Arm A) n=93 participants at risk Patients receive induction therapy comprising rituximab IV on day 1 and bendamustine hydrochloride IV over 60 minutes on days 1-2. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment.	Induction: Bendamustine + Rituximab + Bortezomib (Arm B) n=92 participants at risk Patients receive induction therapy comprising rituximab IV on day 1, bendamustine hydrochloride IV over 60 minutes on days 1-2 and bortezomib IV subcutaneously (SC) on days 1 and 8. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment.	Induction: Bendamustine + Rituximab (Arm C) n=93 participants at risk Patients receive induction therapy comprising rituximab IV on day 1 and bendamustine hydrochloride IV over 60 minutes on days 1-2. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment.	Induction: Bendamustine + Rituximab + Bortezomib (Arm D) n=92 participants at risk Patients receive induction therapy comprising rituximab IV on day 1, bendamustine hydrochloride IV over 60 minutes on days 1-2 and bortezomib IV subcutaneously (SC) on days 1 and 8. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment.	Maintenance: Rituximab (Arm E) n=74 participants at risk Patients receive maintenance therapy comprising rituximab IV on day 1. Courses repeat every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.	Maintenance: Rituximab (Arm F) n=68 participants at risk Patients receive maintenance therapy comprising rituximab IV on day 1. Courses repeat every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.	Maintenance: Lenalidomide + Rituximab (Arm G) n=73 participants at risk Patients receive maintenance therapy comprising lenalidomide orally (PO) daily on days 1-21 every 4 weeks and rituximab IV every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.	Maintenance: Lenalidomide + Rituximab (Arm H) n=73 participants at risk Patients receive maintenance therapy comprising lenalidomide orally (PO) daily on days 1-21 every 4 weeks and rituximab IV every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Infections and infestations Infections and infestations - Other, specify	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.7% 2/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.5% 1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	5.5% 4/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.7% 2/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Investigations Aspartate aminotransferase increased	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.5% 1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	5.5% 4/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	6.8% 5/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Blood and lymphatic system disorders Anemia	65.6% 61/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	58.7% 54/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	65.6% 61/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	62.0% 57/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	54.1% 40/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	54.4% 37/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	72.6% 53/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	78.1% 57/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
General disorders Edema limbs	11.8% 11/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	15.2% 14/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	16.1% 15/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	15.2% 14/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	6.8% 5/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	14.7% 10/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	15.1% 11/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	16.4% 12/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
General disorders Fatigue	72.0% 67/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	68.5% 63/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	75.3% 70/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	78.3% 72/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	63.5% 47/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	52.9% 36/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	76.7% 56/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	72.6% 53/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
General disorders Fever	14.0% 13/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	25.0% 23/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	16.1% 15/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	13.0% 12/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	9.5% 7/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	8.8% 6/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	12.3% 9/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	8.2% 6/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
General disorders Infusion related reaction	14.0% 13/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	15.2% 14/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	12.9% 12/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	5.4% 5/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Skin and subcutaneous tissue disorders Dry skin	5.4% 5/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	9.8% 9/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	6.5% 6/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	7.6% 7/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	6.8% 5/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	4.4% 3/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	21.9% 16/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	20.5% 15/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Skin and subcutaneous tissue disorders Pruritus	3.2% 3/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	3.3% 3/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	6.5% 6/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.5% 1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	6.8% 5/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	4.1% 3/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Skin and subcutaneous tissue disorders Rash maculo-papular	18.3% 17/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	28.3% 26/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	25.8% 24/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	23.9% 22/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	6.8% 5/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	4.4% 3/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	38.4% 28/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	34.2% 25/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.9% 2/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	5.5% 4/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.7% 2/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Gastrointestinal disorders Constipation	32.3% 30/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	39.1% 36/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	37.6% 35/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	43.5% 40/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	6.8% 5/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	8.8% 6/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	39.7% 29/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	27.4% 20/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Gastrointestinal disorders Diarrhea	17.2% 16/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	37.0% 34/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	20.4% 19/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	28.3% 26/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	9.5% 7/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	13.2% 9/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	47.9% 35/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	42.5% 31/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Gastrointestinal disorders Dyspepsia	9.7% 9/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	9.8% 9/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	9.7% 9/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	7.6% 7/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	5.4% 4/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.5% 1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	6.8% 5/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	5.5% 4/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Gastrointestinal disorders Mucositis oral	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	4.1% 3/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.9% 2/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	5.5% 4/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Gastrointestinal disorders Nausea	44.1% 41/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	52.2% 48/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	43.0% 40/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	55.4% 51/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	13.5% 10/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	11.8% 8/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	27.4% 20/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	19.2% 14/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Gastrointestinal disorders Vomiting	4.3% 4/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	18.5% 17/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	7.5% 7/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	17.4% 16/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.7% 2/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.9% 2/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	6.8% 5/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	5.5% 4/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Immune system disorders Allergic reaction	10.8% 10/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	16.3% 15/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	17.2% 16/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	12.0% 11/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.7% 2/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	6.8% 5/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	6.8% 5/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Infections and infestations Bronchial infection	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.7% 2/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	8.2% 6/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	4.1% 3/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Infections and infestations Sinusitis	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	4.1% 3/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.9% 2/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	8.2% 6/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	8.2% 6/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Infections and infestations Upper respiratory infection	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	9.5% 7/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	7.4% 5/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	16.4% 12/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	9.6% 7/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Investigations Creatinine increased	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.5% 1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	5.5% 4/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	5.5% 4/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Investigations Lymphocyte count decreased	54.8% 51/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	55.4% 51/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	63.4% 59/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	68.5% 63/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	75.7% 56/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	66.2% 45/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	75.3% 55/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	84.9% 62/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Investigations Neutrophil count decreased	43.0% 40/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	46.7% 43/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	46.2% 43/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	42.4% 39/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	37.8% 28/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	41.2% 28/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	79.5% 58/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	74.0% 54/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Investigations Platelet count decreased	59.1% 55/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	58.7% 54/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	54.8% 51/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	56.5% 52/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	37.8% 28/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	41.2% 28/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	52.1% 38/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	56.2% 41/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Investigations Weight loss	10.8% 10/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	15.2% 14/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	15.1% 14/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	18.5% 17/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.7% 2/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	10.3% 7/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	8.2% 6/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	12.3% 9/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Investigations White blood cell decreased	73.1% 68/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	65.2% 60/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	72.0% 67/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	68.5% 63/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	67.6% 50/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	64.7% 44/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	84.9% 62/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	83.6% 61/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Metabolism and nutrition disorders Anorexia	20.4% 19/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	27.2% 25/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	23.7% 22/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	27.2% 25/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	4.1% 3/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	8.8% 6/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	15.1% 11/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	19.2% 14/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Metabolism and nutrition disorders Hyponatremia	5.4% 5/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.1% 1/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.2% 2/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.2% 2/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	4.1% 3/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	5.5% 4/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Musculoskeletal and connective tissue disorders Myalgia	2.2% 2/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	5.4% 5/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.2% 2/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.2% 2/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Nervous system disorders Dizziness	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.7% 2/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	6.8% 5/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	4.1% 3/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Nervous system disorders Headache	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	5.5% 4/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	5.9% 4/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	4.1% 3/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.7% 2/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Nervous system disorders Peripheral sensory neuropathy	4.3% 4/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	19.6% 18/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	11.8% 11/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	18.5% 17/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	9.5% 7/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	23.5% 16/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	21.9% 16/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	32.9% 24/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Respiratory, thoracic and mediastinal disorders Cough	4.3% 4/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	5.4% 5/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.2% 2/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	4.3% 4/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	4.1% 3/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	4.4% 3/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	9.6% 7/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	11.0% 8/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.5% 1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	5.5% 4/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	6.8% 5/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.4% 1/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	0.00% 0/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	4.1% 3/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	5.5% 4/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Vascular disorders Hypertension	7.5% 7/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	5.4% 5/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	6.5% 6/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	6.5% 6/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	16.2% 12/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	5.9% 4/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	8.2% 6/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	8.2% 6/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.
Vascular disorders Hypotension	5.4% 5/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	6.5% 6/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	9.7% 9/93 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	8.7% 8/92 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	2.7% 2/74 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	1.5% 1/68 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	5.5% 4/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.	6.8% 5/73 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years and 6 months for Arms A, B, C and D, and up to 10 years for Arms E, F, G and H. Patients who received treatment were included in the analysis of adverse events. All patients enrolled on this study were included in the analysis of all-cause mortality.

Additional Information

Study Statistician

ECOG-ACRIN Statistical Office

Phone: 617-632-3012

Email: eatrials@jimmy.harvard.edu

Results disclosure agreements

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

Restriction type: LTE60