Trial Outcomes & Findings for Brentuximab Vedotin or Crizotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II-IV Anaplastic Large Cell Lymphoma (NCT NCT01979536)

NCT ID: NCT01979536

Last Updated: 2024-04-30

Results Overview

Will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Toxicities will be summarized by individual toxicity counts separated by arm.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

137 participants

Primary outcome timeframe

Up to 60 months

Results posted on

2024-04-30

Participant Flow

Participant milestones

Participant milestones
Measure	Arm BV (Brentuximab Vedotin, Combination Chemotherapy) COURSE A (CYCLES 1, 3, AND 5): Patients receive brentuximab vedotin IV over 30 minutes on day 1, dexamethasone PO BID or IV on days 1-5, ifosfamide IV over 60 minutes on days 1-5, methotrexate IV over 3 hours on day 1, cytarabine IV over 1-30 minutes every 12 hours for 4 doses on days 4 and 5, and etoposide IV over 2 hours on days 4 and 5. COURSE B (CYCLES 2, 4, AND 6): Patients receive brentuximab vedotin, dexamethasone, and methotrexate as in Arm BV, Course A. Patients also receive cyclophosphamide IV over 15-30 minutes on days 1-5 and doxorubicin hydrochloride IV over 1-15 minutes on days 4 and 5. Brentuximab Vedotin: Given IV Cyclophosphamide: Given IV Cytarabine: Given IT and IV Dexamethasone: Given PO or IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ifosfamide: Given IV Methotrexate: Given IT and IV	Arm CZ (Crizotinib, Combination Chemotherapy) COURSE A (CYCLES 1, 3, AND 5): Patients receive crizotinib PO BID on days 1-21 and dexamethasone, ifosfamide, methotrexate, cytarabine, and etoposide as in Arm BV, Course A. COURSE B (CYCLES 2, 4, AND 6): Patients receive crizotinib as in Arm CZ, Course A and dexamethasone, cyclophosphamide, methotrexate, and doxorubicin hydrochloride as in Arm BV, Course B. Crizotinib: Given PO Cyclophosphamide: Given IV Cytarabine: Given IT and IV Dexamethasone: Given PO or IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ifosfamide: Given IV Methotrexate: Given IT and IV
Overall Study STARTED	68	69
Overall Study COMPLETED	66	61
Overall Study NOT COMPLETED	2	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm BV (Brentuximab Vedotin, Combination Chemotherapy) COURSE A (CYCLES 1, 3, AND 5): Patients receive brentuximab vedotin IV over 30 minutes on day 1, dexamethasone PO BID or IV on days 1-5, ifosfamide IV over 60 minutes on days 1-5, methotrexate IV over 3 hours on day 1, cytarabine IV over 1-30 minutes every 12 hours for 4 doses on days 4 and 5, and etoposide IV over 2 hours on days 4 and 5. COURSE B (CYCLES 2, 4, AND 6): Patients receive brentuximab vedotin, dexamethasone, and methotrexate as in Arm BV, Course A. Patients also receive cyclophosphamide IV over 15-30 minutes on days 1-5 and doxorubicin hydrochloride IV over 1-15 minutes on days 4 and 5. Brentuximab Vedotin: Given IV Cyclophosphamide: Given IV Cytarabine: Given IT and IV Dexamethasone: Given PO or IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ifosfamide: Given IV Methotrexate: Given IT and IV	Arm CZ (Crizotinib, Combination Chemotherapy) COURSE A (CYCLES 1, 3, AND 5): Patients receive crizotinib PO BID on days 1-21 and dexamethasone, ifosfamide, methotrexate, cytarabine, and etoposide as in Arm BV, Course A. COURSE B (CYCLES 2, 4, AND 6): Patients receive crizotinib as in Arm CZ, Course A and dexamethasone, cyclophosphamide, methotrexate, and doxorubicin hydrochloride as in Arm BV, Course B. Crizotinib: Given PO Cyclophosphamide: Given IV Cytarabine: Given IT and IV Dexamethasone: Given PO or IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ifosfamide: Given IV Methotrexate: Given IT and IV
Overall Study Physician Decision	2	3
Overall Study Withdrawal by Subject	0	1
Overall Study Refusal	0	1
Overall Study Relapse	0	1
Overall Study Study terminated by Sponsor	0	1
Overall Study Did not start treatment	0	1

Baseline Characteristics

Brentuximab Vedotin or Crizotinib and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II-IV Anaplastic Large Cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm BV (Brentuximab Vedotin, Combination Chemotherapy) n=68 Participants COURSE A (CYCLES 1, 3, AND 5): Patients receive brentuximab vedotin IV over 30 minutes on day 1, dexamethasone PO BID or IV on days 1-5, ifosfamide IV over 60 minutes on days 1-5, methotrexate IV over 3 hours on day 1, cytarabine IV over 1-30 minutes every 12 hours for 4 doses on days 4 and 5, and etoposide IV over 2 hours on days 4 and 5. COURSE B (CYCLES 2, 4, AND 6): Patients receive brentuximab vedotin, dexamethasone, and methotrexate as in Arm BV, Course A. Patients also receive cyclophosphamide IV over 15-30 minutes on days 1-5 and doxorubicin hydrochloride IV over 1-15 minutes on days 4 and 5. Brentuximab Vedotin: Given IV Cyclophosphamide: Given IV Cytarabine: Given IT and IV Dexamethasone: Given PO or IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ifosfamide: Given IV Methotrexate: Given IT and IV	Arm CZ (Crizotinib, Combination Chemotherapy) n=69 Participants COURSE A (CYCLES 1, 3, AND 5): Patients receive crizotinib PO BID on days 1-21 and dexamethasone, ifosfamide, methotrexate, cytarabine, and etoposide as in Arm BV, Course A. COURSE B (CYCLES 2, 4, AND 6): Patients receive crizotinib as in Arm CZ, Course A and dexamethasone, cyclophosphamide, methotrexate, and doxorubicin hydrochloride as in Arm BV, Course B. Crizotinib: Given PO Cyclophosphamide: Given IV Cytarabine: Given IT and IV Dexamethasone: Given PO or IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ifosfamide: Given IV Methotrexate: Given IT and IV	Total n=137 Participants Total of all reporting groups
Age, Categorical <=18 years	64 Participants n=93 Participants	65 Participants n=4 Participants	129 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=93 Participants	4 Participants n=4 Participants	8 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	10.8 years STANDARD_DEVIATION 4.9 • n=93 Participants	13.6 years STANDARD_DEVIATION 3.3 • n=4 Participants	12.2 years STANDARD_DEVIATION 4.4 • n=27 Participants
Sex: Female, Male Female	25 Participants n=93 Participants	22 Participants n=4 Participants	47 Participants n=27 Participants
Sex: Female, Male Male	43 Participants n=93 Participants	47 Participants n=4 Participants	90 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=93 Participants	10 Participants n=4 Participants	15 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	60 Participants n=93 Participants	56 Participants n=4 Participants	116 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	5 Participants n=93 Participants	4 Participants n=4 Participants	9 Participants n=27 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
Race (NIH/OMB) Black or African American	8 Participants n=93 Participants	14 Participants n=4 Participants	22 Participants n=27 Participants
Race (NIH/OMB) White	48 Participants n=93 Participants	46 Participants n=4 Participants	94 Participants n=27 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=93 Participants	5 Participants n=4 Participants	10 Participants n=27 Participants
Region of Enrollment United States	68 participants n=93 Participants	69 participants n=4 Participants	137 participants n=27 Participants

PRIMARY outcome

Timeframe: Up to 60 months

Population: 1 Arm BV patient who did not receive at least one dose of brentuximab vedotin and 3 Arm CZ patients who did not receive at least one dose of crizotinib are excluded from these analyses.

Will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Toxicities will be summarized by individual toxicity counts separated by arm.

Outcome measures

Outcome measures
Measure	Arm BV (Brentuximab Vedotin, Combination Chemotherapy) n=67 Participants COURSE A (CYCLES 1, 3, AND 5): Patients receive brentuximab vedotin IV over 30 minutes on day 1, dexamethasone PO BID or IV on days 1-5, ifosfamide IV over 60 minutes on days 1-5, methotrexate IV over 3 hours on day 1, cytarabine IV over 1-30 minutes every 12 hours for 4 doses on days 4 and 5, and etoposide IV over 2 hours on days 4 and 5. COURSE B (CYCLES 2, 4, AND 6): Patients receive brentuximab vedotin, dexamethasone, and methotrexate as in Arm BV, Course A. Patients also receive cyclophosphamide IV over 15-30 minutes on days 1-5 and doxorubicin hydrochloride IV over 1-15 minutes on days 4 and 5. Brentuximab Vedotin: Given IV Cyclophosphamide: Given IV Cytarabine: Given IT and IV Dexamethasone: Given PO or IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ifosfamide: Given IV Methotrexate: Given IT and IV	Arm CZ (Crizotinib, Combination Chemotherapy) n=66 Participants COURSE A (CYCLES 1, 3, AND 5): Patients receive crizotinib PO BID on days 1-21 and dexamethasone, ifosfamide, methotrexate, cytarabine, and etoposide as in Arm BV, Course A. COURSE B (CYCLES 2, 4, AND 6): Patients receive crizotinib as in Arm CZ, Course A and dexamethasone, cyclophosphamide, methotrexate, and doxorubicin hydrochloride as in Arm BV, Course B. Crizotinib: Given PO Cyclophosphamide: Given IV Cytarabine: Given IT and IV Dexamethasone: Given PO or IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ifosfamide: Given IV Methotrexate: Given IT and IV	MRD Negative Arm CZ (Crizotinib, Combination Chemotherapy) COURSE A (CYCLES 1, 3, AND 5): Patients receive crizotinib PO BID on days 1-21 and dexamethasone, ifosfamide, methotrexate, cytarabine, and etoposide as in Arm BV, Course A. COURSE B (CYCLES 2, 4, AND 6): Patients receive crizotinib as in Arm CZ, Course A and dexamethasone, cyclophosphamide, methotrexate, and doxorubicin hydrochloride as in Arm BV, Course B.	MRD Positive Arm CZ (Crizotinib, Combination Chemotherapy) COURSE A (CYCLES 1, 3, AND 5): Patients receive crizotinib PO BID on days 1-21 and dexamethasone, ifosfamide, methotrexate, cytarabine, and etoposide as in Arm BV, Course A. COURSE B (CYCLES 2, 4, AND 6): Patients receive crizotinib as in Arm CZ, Course A and dexamethasone, cyclophosphamide, methotrexate, and doxorubicin hydrochloride as in Arm BV, Course B.
Occurrence of Grade 3+ Non-hematologic Adverse Events	80.6 Percentage of patients Interval 69.1 to 89.2	87.9 Percentage of patients Interval 77.5 to 94.6	—	—

PRIMARY outcome

Timeframe: Time from study entry until progressive disease, relapse, or death, assessed up to 2 years

Population: 1 Arm CZ patient who did not start treatment is excluded from analyses of EFS.

The Kaplan-Meier method will be used to estimate the 2-year EFS for each of the treatment regimens.

Outcome measures

Outcome measures
Measure	Arm BV (Brentuximab Vedotin, Combination Chemotherapy) n=68 Participants COURSE A (CYCLES 1, 3, AND 5): Patients receive brentuximab vedotin IV over 30 minutes on day 1, dexamethasone PO BID or IV on days 1-5, ifosfamide IV over 60 minutes on days 1-5, methotrexate IV over 3 hours on day 1, cytarabine IV over 1-30 minutes every 12 hours for 4 doses on days 4 and 5, and etoposide IV over 2 hours on days 4 and 5. COURSE B (CYCLES 2, 4, AND 6): Patients receive brentuximab vedotin, dexamethasone, and methotrexate as in Arm BV, Course A. Patients also receive cyclophosphamide IV over 15-30 minutes on days 1-5 and doxorubicin hydrochloride IV over 1-15 minutes on days 4 and 5. Brentuximab Vedotin: Given IV Cyclophosphamide: Given IV Cytarabine: Given IT and IV Dexamethasone: Given PO or IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ifosfamide: Given IV Methotrexate: Given IT and IV	Arm CZ (Crizotinib, Combination Chemotherapy) n=68 Participants COURSE A (CYCLES 1, 3, AND 5): Patients receive crizotinib PO BID on days 1-21 and dexamethasone, ifosfamide, methotrexate, cytarabine, and etoposide as in Arm BV, Course A. COURSE B (CYCLES 2, 4, AND 6): Patients receive crizotinib as in Arm CZ, Course A and dexamethasone, cyclophosphamide, methotrexate, and doxorubicin hydrochloride as in Arm BV, Course B. Crizotinib: Given PO Cyclophosphamide: Given IV Cytarabine: Given IT and IV Dexamethasone: Given PO or IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ifosfamide: Given IV Methotrexate: Given IT and IV	MRD Negative Arm CZ (Crizotinib, Combination Chemotherapy) COURSE A (CYCLES 1, 3, AND 5): Patients receive crizotinib PO BID on days 1-21 and dexamethasone, ifosfamide, methotrexate, cytarabine, and etoposide as in Arm BV, Course A. COURSE B (CYCLES 2, 4, AND 6): Patients receive crizotinib as in Arm CZ, Course A and dexamethasone, cyclophosphamide, methotrexate, and doxorubicin hydrochloride as in Arm BV, Course B.	MRD Positive Arm CZ (Crizotinib, Combination Chemotherapy) COURSE A (CYCLES 1, 3, AND 5): Patients receive crizotinib PO BID on days 1-21 and dexamethasone, ifosfamide, methotrexate, cytarabine, and etoposide as in Arm BV, Course A. COURSE B (CYCLES 2, 4, AND 6): Patients receive crizotinib as in Arm CZ, Course A and dexamethasone, cyclophosphamide, methotrexate, and doxorubicin hydrochloride as in Arm BV, Course B.
Event Free Survival (EFS)	78.8 Percentage of patients Interval 67.2 to 87.1	76.8 Percentage of patients Interval 68.5 to 88.1	—	—

SECONDARY outcome

Timeframe: Baseline up to progressive disease, relapse, or death, assessed up to 2 years

Population: 11 Arm BV patients without adequate MDD baseline data, 1 Arm CZ patient who did not start treatment, and 11 Arm CZ patients without adequate MDD baseline data are excluded from these analyses.

Analyzed by estimating the 2-year EFS of negative MRD and positive MRD by arm. Minimal disease was performed using serial assessments of the t(2;5)(p23;q35) NPM-ALK fusion transcript using quantitative RT-PCR. Quantitative RT-PCR was performed by extracting total RNA from peripheral blood specimens. Peripheral blood samples were obtained at baseline, on day 1 of cycle 1, and on day 1 of cycle 2. The normalized copy numbers (NCN) were expressed as copy numbers of NPM-ALK per 104 copies of ABL. Minimal disease (MDD) was defined as \>10 NCN at baseline.

Outcome measures

Outcome measures
Measure	Arm BV (Brentuximab Vedotin, Combination Chemotherapy) n=38 Participants COURSE A (CYCLES 1, 3, AND 5): Patients receive brentuximab vedotin IV over 30 minutes on day 1, dexamethasone PO BID or IV on days 1-5, ifosfamide IV over 60 minutes on days 1-5, methotrexate IV over 3 hours on day 1, cytarabine IV over 1-30 minutes every 12 hours for 4 doses on days 4 and 5, and etoposide IV over 2 hours on days 4 and 5. COURSE B (CYCLES 2, 4, AND 6): Patients receive brentuximab vedotin, dexamethasone, and methotrexate as in Arm BV, Course A. Patients also receive cyclophosphamide IV over 15-30 minutes on days 1-5 and doxorubicin hydrochloride IV over 1-15 minutes on days 4 and 5. Brentuximab Vedotin: Given IV Cyclophosphamide: Given IV Cytarabine: Given IT and IV Dexamethasone: Given PO or IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ifosfamide: Given IV Methotrexate: Given IT and IV	Arm CZ (Crizotinib, Combination Chemotherapy) n=19 Participants COURSE A (CYCLES 1, 3, AND 5): Patients receive crizotinib PO BID on days 1-21 and dexamethasone, ifosfamide, methotrexate, cytarabine, and etoposide as in Arm BV, Course A. COURSE B (CYCLES 2, 4, AND 6): Patients receive crizotinib as in Arm CZ, Course A and dexamethasone, cyclophosphamide, methotrexate, and doxorubicin hydrochloride as in Arm BV, Course B. Crizotinib: Given PO Cyclophosphamide: Given IV Cytarabine: Given IT and IV Dexamethasone: Given PO or IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ifosfamide: Given IV Methotrexate: Given IT and IV	MRD Negative Arm CZ (Crizotinib, Combination Chemotherapy) n=37 Participants COURSE A (CYCLES 1, 3, AND 5): Patients receive crizotinib PO BID on days 1-21 and dexamethasone, ifosfamide, methotrexate, cytarabine, and etoposide as in Arm BV, Course A. COURSE B (CYCLES 2, 4, AND 6): Patients receive crizotinib as in Arm CZ, Course A and dexamethasone, cyclophosphamide, methotrexate, and doxorubicin hydrochloride as in Arm BV, Course B.	MRD Positive Arm CZ (Crizotinib, Combination Chemotherapy) n=20 Participants COURSE A (CYCLES 1, 3, AND 5): Patients receive crizotinib PO BID on days 1-21 and dexamethasone, ifosfamide, methotrexate, cytarabine, and etoposide as in Arm BV, Course A. COURSE B (CYCLES 2, 4, AND 6): Patients receive crizotinib as in Arm CZ, Course A and dexamethasone, cyclophosphamide, methotrexate, and doxorubicin hydrochloride as in Arm BV, Course B.
Prognostic Significance of Minimal Residual Disease	89 Percentage of patients Interval 73.1 to 95.7	52.6 Percentage of patients Interval 28.7 to 71.9	85.6 Percentage of patients Interval 68.6 to 93.8	58.1 Percentage of patients Interval 33.4 to 76.4

Adverse Events

Arm BV (Brentuximab Vedotin, Combination Chemotherapy)

Serious events: 24 serious events

Other events: 57 other events

Deaths: 3 deaths

Arm CZ (Crizotinib, Combination Chemotherapy)

Serious events: 41 serious events

Other events: 55 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Additional Information

Results Reporting Coordinator

Children's Oncology Group

Phone: 16264470064

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Serious adverse events
Measure	Arm BV (Brentuximab Vedotin, Combination Chemotherapy) n=68 participants at risk COURSE A (CYCLES 1, 3, AND 5): Patients receive brentuximab vedotin IV over 30 minutes on day 1, dexamethasone PO BID or IV on days 1-5, ifosfamide IV over 60 minutes on days 1-5, methotrexate IV over 3 hours on day 1, cytarabine IV over 1-30 minutes every 12 hours for 4 doses on days 4 and 5, and etoposide IV over 2 hours on days 4 and 5. COURSE B (CYCLES 2, 4, AND 6): Patients receive brentuximab vedotin, dexamethasone, and methotrexate as in Arm BV, Course A. Patients also receive cyclophosphamide IV over 15-30 minutes on days 1-5 and doxorubicin hydrochloride IV over 1-15 minutes on days 4 and 5. Brentuximab Vedotin: Given IV Cyclophosphamide: Given IV Cytarabine: Given IT and IV Dexamethasone: Given PO or IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ifosfamide: Given IV Methotrexate: Given IT and IV	Arm CZ (Crizotinib, Combination Chemotherapy) n=68 participants at risk COURSE A (CYCLES 1, 3, AND 5): Patients receive crizotinib PO BID on days 1-21 and dexamethasone, ifosfamide, methotrexate, cytarabine, and etoposide as in Arm BV, Course A. COURSE B (CYCLES 2, 4, AND 6): Patients receive crizotinib as in Arm CZ, Course A and dexamethasone, cyclophosphamide, methotrexate, and doxorubicin hydrochloride as in Arm BV, Course B. Crizotinib: Given PO Cyclophosphamide: Given IV Cytarabine: Given IT and IV Dexamethasone: Given PO or IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ifosfamide: Given IV Methotrexate: Given IT and IV
Blood and lymphatic system disorders Anemia	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Blood and lymphatic system disorders Febrile neutropenia	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	10.3% 7/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Cardiac disorders Sinus tachycardia	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Endocrine disorders Adrenal insufficiency	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Abdominal pain	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Colitis	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Diarrhea	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Esophagitis	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Ileus	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Mucositis oral	17.6% 12/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	23.5% 16/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Nausea	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	2.9% 2/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Oral pain	4.4% 3/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Typhlitis	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	2.9% 2/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Vomiting	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	4.4% 3/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
General disorders Death NOS	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	4.4% 3/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Investigations Neutrophil count decreased	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
General disorders Fever	2.9% 2/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	2.9% 2/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Immune system disorders Anaphylaxis	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Catheter related infection	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Infections and infestations - Other, specify	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Lung infection	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	2.9% 2/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Sepsis	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	4.4% 3/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Skin infection	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Upper respiratory infection	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Urinary tract infection	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Injury, poisoning and procedural complications Vascular access complication	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	2.9% 2/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Investigations Alanine aminotransferase increased	7.4% 5/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	4.4% 3/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Investigations Blood bilirubin increased	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Investigations Electrocardiogram QT corrected interval prolonged	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Investigations Urine output decreased	2.9% 2/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Investigations White blood cell decreased	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	2.9% 2/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Metabolism and nutrition disorders Anorexia	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Metabolism and nutrition disorders Dehydration	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	5.9% 4/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Metabolism and nutrition disorders Hyperglycemia	2.9% 2/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Metabolism and nutrition disorders Hypokalemia	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	7.4% 5/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Metabolism and nutrition disorders Hyponatremia	5.9% 4/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	2.9% 2/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.

Other adverse events
Measure	Arm BV (Brentuximab Vedotin, Combination Chemotherapy) n=68 participants at risk COURSE A (CYCLES 1, 3, AND 5): Patients receive brentuximab vedotin IV over 30 minutes on day 1, dexamethasone PO BID or IV on days 1-5, ifosfamide IV over 60 minutes on days 1-5, methotrexate IV over 3 hours on day 1, cytarabine IV over 1-30 minutes every 12 hours for 4 doses on days 4 and 5, and etoposide IV over 2 hours on days 4 and 5. COURSE B (CYCLES 2, 4, AND 6): Patients receive brentuximab vedotin, dexamethasone, and methotrexate as in Arm BV, Course A. Patients also receive cyclophosphamide IV over 15-30 minutes on days 1-5 and doxorubicin hydrochloride IV over 1-15 minutes on days 4 and 5. Brentuximab Vedotin: Given IV Cyclophosphamide: Given IV Cytarabine: Given IT and IV Dexamethasone: Given PO or IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ifosfamide: Given IV Methotrexate: Given IT and IV	Arm CZ (Crizotinib, Combination Chemotherapy) n=68 participants at risk COURSE A (CYCLES 1, 3, AND 5): Patients receive crizotinib PO BID on days 1-21 and dexamethasone, ifosfamide, methotrexate, cytarabine, and etoposide as in Arm BV, Course A. COURSE B (CYCLES 2, 4, AND 6): Patients receive crizotinib as in Arm CZ, Course A and dexamethasone, cyclophosphamide, methotrexate, and doxorubicin hydrochloride as in Arm BV, Course B. Crizotinib: Given PO Cyclophosphamide: Given IV Cytarabine: Given IT and IV Dexamethasone: Given PO or IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ifosfamide: Given IV Methotrexate: Given IT and IV
Blood and lymphatic system disorders Anemia	32.4% 22/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	39.7% 27/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Blood and lymphatic system disorders Febrile neutropenia	44.1% 30/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	44.1% 30/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Eye disorders Periorbital edema	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Abdominal pain	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	2.9% 2/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Colitis	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Dental caries	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Diarrhea	4.4% 3/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	4.4% 3/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Dysphagia	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Enterocolitis	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Ileus	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Mucositis oral	8.8% 6/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	16.2% 11/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Nausea	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	2.9% 2/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Oral pain	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Rectal pain	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Vomiting	7.4% 5/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	4.4% 3/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
General disorders Fatigue	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
General disorders Fever	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
General disorders Pain	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Appendicitis	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Catheter related infection	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Endocarditis infective	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Enterocolitis infectious	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Infections and infestations - Other, specify	11.8% 8/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	7.4% 5/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Kidney infection	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Lung infection	4.4% 3/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Otitis media	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Scrotal infection	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Skin infection	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Soft tissue infection	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Upper respiratory infection	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	2.9% 2/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Urinary tract infection	2.9% 2/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Investigations Alanine aminotransferase increased	13.2% 9/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	13.2% 9/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Investigations Alkaline phosphatase increased	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Investigations Aspartate aminotransferase increased	10.3% 7/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	4.4% 3/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Investigations Creatinine increased	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Investigations Electrocardiogram QT corrected interval prolonged	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.
Investigations Fibrinogen decreased	0.00% 0/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.	1.5% 1/68 • Enrollment up to 5 years after enrollment Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Patients who did not start treatment are excluded from reporting of AEs. All-Cause Mortality includes all deaths collected on the study.