Trial Outcomes & Findings for Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement (NCT NCT02828358)

Last Updated: 2025-02-27

Results Overview

Proportion of KMT2A-Rearranged patients treated with azacitidine with Dose Limiting Toxicities (DLTs) from the first course of azacitidine administration up to fourth course of azacitidine administration.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

78 participants

Primary outcome timeframe

6 months

Results posted on

2025-02-27

Participant Flow

Infants less than 1 year of age with newly diagnosed B lymphoblastic leukemia (also termed B-precursor acute lymphoblastic leukemia) or acute leukemia of ambiguous lineage

Enrolled patients receive common induction therapy. Genetic evaluation results in patients being stratified into KMT2A-Germline and KMT2A-Rearranged groups. KMT2A-Germline patients go off protocol therapy post-induction.

Participant milestones

Participant milestones
Measure	KMT2A-Rearranged INDUCTION: Same as KMT2A-Germline (Group 2). AZACITIDINE (AZA) I: AZA over 10-40 minutes for 5 days. CONSOLIDATION: cyclophosphamide days 1/29; mercaptopurine (6-MP) days 1-28; ARA-C days 3-6, 10-13, 17-20, 24-27; MTX IT day 24; HC days 10/24. AZA II: Same as AZA I. INTERIM MAINTENANCE: 6-MP days 1-14; MTX 1/2/8/9; leucovorin calcium days 3-4,10-11; HC days 2/9; ARA-C days 15-16, 22-23; PEG day 23. AZA III: Same as AZA I. DELAYED INTENSIFICATION (DI) I: PEG day 1; dexamethasone days 1-14, 15-21; thioguanine days 1-28; vincristine sulfate and daunorubicin hydrochloride days 1/8/15/22; ARA-C days 1-5, 9-12, 15-19, 23-26; HC on days 1/15. AZA IV: Same as AZA I. DI II: thioguanine days 1-14; cyclophosphamide days 1/15; ARA-C days 2-5, 9-12. MAINTENANCE: 6-MP days 1-168, MTX IT day 1/92; MTX weekly days 8-91,98-168; HC day 1/57/99; ARA-C day 57. Starting day 169, 6-MP days 1-84 and MTX weekly. Cycles repeat every 84 days for 2 years from start of Induction.	KMT2A-Germline Induction: Methotrexate intrathecally (IT) on days 1 and 29, prednisolone orally (PO) or nasogastrically (NG) three times daily (TID) on days 1-7, daunorubicin hydrochloride intravenously (IV) over 1-15 minutes on days 8-9, cytarabine (ARA-C) IV over 30 minutes on days 8-21 and IT on day 15, dexamethasone PO, NG, or IV TID on days 8-28, vincristine sulfate IV over 1 minute on days 8, 15, 22, and 29, pegaspargase (PEG) IV over 1-2 hours or intramuscularly (IM) on day 12, and hydrocortisone sodium succinate (HC) IT on days 15 and 29 in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	56	22
Overall Study COMPLETED	11	0
Overall Study NOT COMPLETED	45	22

Reasons for withdrawal

Reasons for withdrawal
Measure	KMT2A-Rearranged INDUCTION: Same as KMT2A-Germline (Group 2). AZACITIDINE (AZA) I: AZA over 10-40 minutes for 5 days. CONSOLIDATION: cyclophosphamide days 1/29; mercaptopurine (6-MP) days 1-28; ARA-C days 3-6, 10-13, 17-20, 24-27; MTX IT day 24; HC days 10/24. AZA II: Same as AZA I. INTERIM MAINTENANCE: 6-MP days 1-14; MTX 1/2/8/9; leucovorin calcium days 3-4,10-11; HC days 2/9; ARA-C days 15-16, 22-23; PEG day 23. AZA III: Same as AZA I. DELAYED INTENSIFICATION (DI) I: PEG day 1; dexamethasone days 1-14, 15-21; thioguanine days 1-28; vincristine sulfate and daunorubicin hydrochloride days 1/8/15/22; ARA-C days 1-5, 9-12, 15-19, 23-26; HC on days 1/15. AZA IV: Same as AZA I. DI II: thioguanine days 1-14; cyclophosphamide days 1/15; ARA-C days 2-5, 9-12. MAINTENANCE: 6-MP days 1-168, MTX IT day 1/92; MTX weekly days 8-91,98-168; HC day 1/57/99; ARA-C day 57. Starting day 169, 6-MP days 1-84 and MTX weekly. Cycles repeat every 84 days for 2 years from start of Induction.	KMT2A-Germline Induction: Methotrexate intrathecally (IT) on days 1 and 29, prednisolone orally (PO) or nasogastrically (NG) three times daily (TID) on days 1-7, daunorubicin hydrochloride intravenously (IV) over 1-15 minutes on days 8-9, cytarabine (ARA-C) IV over 30 minutes on days 8-21 and IT on day 15, dexamethasone PO, NG, or IV TID on days 8-28, vincristine sulfate IV over 1 minute on days 8, 15, 22, and 29, pegaspargase (PEG) IV over 1-2 hours or intramuscularly (IM) on day 12, and hydrocortisone sodium succinate (HC) IT on days 15 and 29 in the absence of disease progression or unacceptable toxicity.
Overall Study Physician Decision	7	1
Overall Study Treatment Failure	6	0
Overall Study Patients without KMT2A rearrangement	0	21
Overall Study Refusal of further protocol therapy	2	0
Overall Study Relapse	25	0
Overall Study Still on therapy	5	0

Baseline Characteristics

Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	KMT2A-Rearranged n=56 Participants INDUCTION: Same as KMT2A-Germline (Group 2). AZACITIDINE (AZA) I: AZA over 10-40 minutes for 5 days. CONSOLIDATION: cyclophosphamide days 1/29; mercaptopurine (6-MP) days 1-28; ARA-C days 3-6, 10-13, 17-20, 24-27; MTX IT day 24; HC days 10/24. AZA II: Same as AZA I. INTERIM MAINTENANCE: 6-MP days 1-14; MTX 1/2/8/9; leucovorin calcium days 3-4,10-11; HC days 2/9; ARA-C days 15-16, 22-23; PEG day 23. AZA III: Same as AZA I. DELAYED INTENSIFICATION (DI) I: PEG day 1; dexamethasone days 1-14, 15-21; thioguanine days 1-28; vincristine sulfate and daunorubicin hydrochloride days 1/8/15/22; ARA-C days 1-5, 9-12, 15-19, 23-26; HC on days 1/15. AZA IV: Same as AZA I. DI II: thioguanine days 1-14; cyclophosphamide days 1/15; ARA-C days 2-5, 9-12. MAINTENANCE: 6-MP days 1-168, MTX IT day 1/92; MTX weekly days 8-91,98-168; HC day 1/57/99; ARA-C day 57. Starting day 169, 6-MP days 1-84 and MTX weekly. Cycles repeat every 84 days for 2 years from start of Induction.	KMT2A-Germline n=22 Participants Induction: Methotrexate intrathecally (IT) on days 1 and 29, prednisolone orally (PO) or nasogastrically (NG) three times daily (TID) on days 1-7, daunorubicin hydrochloride intravenously (IV) over 1-15 minutes on days 8-9, cytarabine (ARA-C) IV over 30 minutes on days 8-21 and IT on day 15, dexamethasone PO, NG, or IV TID on days 8-28, vincristine sulfate IV over 1 minute on days 8, 15, 22, and 29, pegaspargase (PEG) IV over 1-2 hours or intramuscularly (IM) on day 12, and hydrocortisone sodium succinate (HC) IT on days 15 and 29 in the absence of disease progression or unacceptable toxicity.	Total n=78 Participants Total of all reporting groups
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	0.48 Years STANDARD_DEVIATION 0.29 • n=5 Participants	0.74 Years STANDARD_DEVIATION 0.2 • n=7 Participants	0.55 Years STANDARD_DEVIATION 0.29 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	12 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	10 Participants n=7 Participants	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants	4 Participants n=7 Participants	15 Participants n=5 Participants
Age, Categorical <=18 years	56 Participants n=5 Participants	22 Participants n=7 Participants	78 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=5 Participants	17 Participants n=7 Participants	57 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	40 Participants n=5 Participants	15 Participants n=7 Participants	55 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	2 Participants n=7 Participants	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: KMT2A-Rearranged patients evaluable for dose-limiting toxicity assessment

Outcome measures

Outcome measures
Measure	KMT2A-Rearranged n=31 Participants INDUCTION: Same as KMT2A-Germline (Group 2). AZACITIDINE (AZA) I: AZA over 10-40 minutes for 5 days. CONSOLIDATION: cyclophosphamide days 1/29; mercaptopurine (6-MP) days 1-28; ARA-C days 3-6, 10-13, 17-20, 24-27; MTX IT day 24; HC days 10/24. AZA II: Same as AZA I. INTERIM MAINTENANCE: 6-MP days 1-14; MTX 1/2/8/9; leucovorin calcium days 3-4,10-11; HC days 2/9; ARA-C days 15-16, 22-23; PEG day 23. AZA III: Same as AZA I. DELAYED INTENSIFICATION (DI) I: PEG day 1; dexamethasone days 1-14, 15-21; thioguanine days 1-28; vincristine sulfate and daunorubicin hydrochloride days 1/8/15/22; ARA-C days 1-5, 9-12, 15-19, 23-26; HC on days 1/15. AZA IV: Same as AZA I. DI II: thioguanine days 1-14; cyclophosphamide days 1/15; ARA-C days 2-5, 9-12. MAINTENANCE: 6-MP days 1-168, MTX IT day 1/92; MTX weekly days 8-91,98-168; HC day 1/57/99; ARA-C day 57. Starting day 169, 6-MP days 1-84 and MTX weekly. Cycles repeat every 84 days for 2 years from start of Induction.
Tolerability of Azacitidine in Combination With Interfant-06 Standard Chemotherapy in Evaluable Infant Patients With Newly Diagnosed ALL With KMT2A Gene Rearrangement (KMT2A-R). KMT2A Gene Rearrangement (KMT2A-R)	6.45 percentage of participants Interval 0.0 to 15.1

SECONDARY outcome

Timeframe: Week 6, Day 1 (Following the induction phase (35 days), the first course of Azacitidine began around Week 6 of therapy)

Population: Patients with methylation data. KMT2A-Germline patients did not have data collected as they came off therapy at the end of Induction

Will calculate the percentage of CpG site methylation for all patients before the first course of azacitidine. Mean and standard deviation will be reported.

Outcome measures

Outcome measures
Measure	KMT2A-Rearranged n=31 Participants INDUCTION: Same as KMT2A-Germline (Group 2). AZACITIDINE (AZA) I: AZA over 10-40 minutes for 5 days. CONSOLIDATION: cyclophosphamide days 1/29; mercaptopurine (6-MP) days 1-28; ARA-C days 3-6, 10-13, 17-20, 24-27; MTX IT day 24; HC days 10/24. AZA II: Same as AZA I. INTERIM MAINTENANCE: 6-MP days 1-14; MTX 1/2/8/9; leucovorin calcium days 3-4,10-11; HC days 2/9; ARA-C days 15-16, 22-23; PEG day 23. AZA III: Same as AZA I. DELAYED INTENSIFICATION (DI) I: PEG day 1; dexamethasone days 1-14, 15-21; thioguanine days 1-28; vincristine sulfate and daunorubicin hydrochloride days 1/8/15/22; ARA-C days 1-5, 9-12, 15-19, 23-26; HC on days 1/15. AZA IV: Same as AZA I. DI II: thioguanine days 1-14; cyclophosphamide days 1/15; ARA-C days 2-5, 9-12. MAINTENANCE: 6-MP days 1-168, MTX IT day 1/92; MTX weekly days 8-91,98-168; HC day 1/57/99; ARA-C day 57. Starting day 169, 6-MP days 1-84 and MTX weekly. Cycles repeat every 84 days for 2 years from start of Induction.
Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 1 Prior to First Course of Azacitidine	78.17 Percentage of CpG methylation Standard Deviation 1.62

SECONDARY outcome

Timeframe: Week 6, Day 5 (Following the induction phase (35 days), the first course of Azacitidine began around Week 6 of therapy)

Population: Patients with methylation data. KMT2A-Germline patients did not have data collected as they came off therapy at the end of Induction

Will calculate the percentage of CpG site methylation for all patients after the first course of azacitidine. Mean and standard deviation will be reported.

Outcome measures

Outcome measures
Measure	KMT2A-Rearranged n=31 Participants INDUCTION: Same as KMT2A-Germline (Group 2). AZACITIDINE (AZA) I: AZA over 10-40 minutes for 5 days. CONSOLIDATION: cyclophosphamide days 1/29; mercaptopurine (6-MP) days 1-28; ARA-C days 3-6, 10-13, 17-20, 24-27; MTX IT day 24; HC days 10/24. AZA II: Same as AZA I. INTERIM MAINTENANCE: 6-MP days 1-14; MTX 1/2/8/9; leucovorin calcium days 3-4,10-11; HC days 2/9; ARA-C days 15-16, 22-23; PEG day 23. AZA III: Same as AZA I. DELAYED INTENSIFICATION (DI) I: PEG day 1; dexamethasone days 1-14, 15-21; thioguanine days 1-28; vincristine sulfate and daunorubicin hydrochloride days 1/8/15/22; ARA-C days 1-5, 9-12, 15-19, 23-26; HC on days 1/15. AZA IV: Same as AZA I. DI II: thioguanine days 1-14; cyclophosphamide days 1/15; ARA-C days 2-5, 9-12. MAINTENANCE: 6-MP days 1-168, MTX IT day 1/92; MTX weekly days 8-91,98-168; HC day 1/57/99; ARA-C day 57. Starting day 169, 6-MP days 1-84 and MTX weekly. Cycles repeat every 84 days for 2 years from start of Induction.
Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 5 of First Course of Azacitidine	75.54 Percentage of CpG methylation Standard Deviation 2.68

SECONDARY outcome

Timeframe: Week 13, Day 1 (Following induction phase (5 weeks), the first course of Azacitidine (1 week), and consolidation (6 weeks), the second course of Azacitidine began around Week 13 of therapy)

Population: Patients with methylation data. KMT2A-Germline patients did not have data collected as they came off therapy at the end of Induction

Will calculate the percentage of CpG site methylation for all patients before the second course of azacitidine. Mean and standard deviation will be reported.

Outcome measures

Outcome measures
Measure	KMT2A-Rearranged n=26 Participants INDUCTION: Same as KMT2A-Germline (Group 2). AZACITIDINE (AZA) I: AZA over 10-40 minutes for 5 days. CONSOLIDATION: cyclophosphamide days 1/29; mercaptopurine (6-MP) days 1-28; ARA-C days 3-6, 10-13, 17-20, 24-27; MTX IT day 24; HC days 10/24. AZA II: Same as AZA I. INTERIM MAINTENANCE: 6-MP days 1-14; MTX 1/2/8/9; leucovorin calcium days 3-4,10-11; HC days 2/9; ARA-C days 15-16, 22-23; PEG day 23. AZA III: Same as AZA I. DELAYED INTENSIFICATION (DI) I: PEG day 1; dexamethasone days 1-14, 15-21; thioguanine days 1-28; vincristine sulfate and daunorubicin hydrochloride days 1/8/15/22; ARA-C days 1-5, 9-12, 15-19, 23-26; HC on days 1/15. AZA IV: Same as AZA I. DI II: thioguanine days 1-14; cyclophosphamide days 1/15; ARA-C days 2-5, 9-12. MAINTENANCE: 6-MP days 1-168, MTX IT day 1/92; MTX weekly days 8-91,98-168; HC day 1/57/99; ARA-C day 57. Starting day 169, 6-MP days 1-84 and MTX weekly. Cycles repeat every 84 days for 2 years from start of Induction.
Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 1 Prior to Second Course of Azacitidine	76.5 Percentage of CpG methylation Standard Deviation 2.68

SECONDARY outcome

Timeframe: Week 13, Day 5 (Following induction phase (5 weeks), the first course of Azacitidine (1 week), and consolidation (6 weeks), the second course of Azacitidine began around Week 13 of therapy)

Population: Patients with methylation data. KMT2A-Germline patients did not have data collected as they came off therapy at the end of Induction.

Will calculate the percentage of CpG site methylation for all patients after the second course of azacitidine. Mean and standard deviation will be reported.

Outcome measures

Outcome measures
Measure	KMT2A-Rearranged n=27 Participants INDUCTION: Same as KMT2A-Germline (Group 2). AZACITIDINE (AZA) I: AZA over 10-40 minutes for 5 days. CONSOLIDATION: cyclophosphamide days 1/29; mercaptopurine (6-MP) days 1-28; ARA-C days 3-6, 10-13, 17-20, 24-27; MTX IT day 24; HC days 10/24. AZA II: Same as AZA I. INTERIM MAINTENANCE: 6-MP days 1-14; MTX 1/2/8/9; leucovorin calcium days 3-4,10-11; HC days 2/9; ARA-C days 15-16, 22-23; PEG day 23. AZA III: Same as AZA I. DELAYED INTENSIFICATION (DI) I: PEG day 1; dexamethasone days 1-14, 15-21; thioguanine days 1-28; vincristine sulfate and daunorubicin hydrochloride days 1/8/15/22; ARA-C days 1-5, 9-12, 15-19, 23-26; HC on days 1/15. AZA IV: Same as AZA I. DI II: thioguanine days 1-14; cyclophosphamide days 1/15; ARA-C days 2-5, 9-12. MAINTENANCE: 6-MP days 1-168, MTX IT day 1/92; MTX weekly days 8-91,98-168; HC day 1/57/99; ARA-C day 57. Starting day 169, 6-MP days 1-84 and MTX weekly. Cycles repeat every 84 days for 2 years from start of Induction.
Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 5 of Second Course of Azacitidine	74.52 Percentage of CpG methylation Standard Deviation 2.09

Adverse Events

KMT2A-Rearranged

Serious events: 34 serious events

Other events: 36 other events

Deaths: 17 deaths

KMT2A-Germline

Serious events: 1 serious events

Other events: 10 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Results Reporting Coordinator

Children's Oncology Group

Phone: 626-447-0064

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Serious adverse events
Measure	KMT2A-Rearranged n=56 participants at risk INDUCTION: Same as KMT2A-Germline (Group 2). AZACITIDINE (AZA) I: AZA over 10-40 minutes for 5 days. CONSOLIDATION: cyclophosphamide days 1/29; mercaptopurine (6-MP) days 1-28; ARA-C days 3-6, 10-13, 17-20, 24-27; MTX IT day 24; HC days 10/24. AZA II: Same as AZA I. INTERIM MAINTENANCE: 6-MP days 1-14; MTX 1/2/8/9; leucovorin calcium days 3-4,10-11; HC days 2/9; ARA-C days 15-16, 22-23; PEG day 23. AZA III: Same as AZA I. DELAYED INTENSIFICATION (DI) I: PEG day 1; dexamethasone days 1-14, 15-21; thioguanine days 1-28; vincristine sulfate and daunorubicin hydrochloride days 1/8/15/22; ARA-C days 1-5, 9-12, 15-19, 23-26; HC on days 1/15. AZA IV: Same as AZA I. DI II: thioguanine days 1-14; cyclophosphamide days 1/15; ARA-C days 2-5, 9-12. MAINTENANCE: 6-MP days 1-168, MTX IT day 1/92; MTX weekly days 8-91,98-168; HC day 1/57/99; ARA-C day 57. Starting day 169, 6-MP days 1-84 and MTX weekly. Cycles repeat every 84 days for 2 years from start of Induction.	KMT2A-Germline n=22 participants at risk Induction: Methotrexate intrathecally (IT) on days 1 and 29, prednisolone orally (PO) or nasogastrically (NG) three times daily (TID) on days 1-7, daunorubicin hydrochloride intravenously (IV) over 1-15 minutes on days 8-9, cytarabine (ARA-C) IV over 30 minutes on days 8-21 and IT on day 15, dexamethasone PO, NG, or IV TID on days 8-28, vincristine sulfate IV over 1 minute on days 8, 15, 22, and 29, pegaspargase (PEG) IV over 1-2 hours or intramuscularly (IM) on day 12, and hydrocortisone sodium succinate (HC) IT on days 15 and 29 in the absence of disease progression or unacceptable toxicity.
Investigations Alanine aminotransferase increased	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Investigations Aspartate aminotransferase increased	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Cardiac disorders Cardiac arrest	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
General disorders Death NOS	19.6% 11/56 • Number of events 11 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	4.5% 1/22 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Blood and lymphatic system disorders Disseminated intravascular coagulation	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Enterocolitis	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
General disorders General disorders and administration site conditions - Other, specify	3.6% 2/56 • Number of events 2 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Vascular disorders Hematoma	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Hepatobiliary disorders Hepatic failure	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Metabolism and nutrition disorders Hyperglycemia	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Metabolism and nutrition disorders Hypertriglyceridemia	3.6% 2/56 • Number of events 2 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Metabolism and nutrition disorders Hypokalemia	5.4% 3/56 • Number of events 3 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Blood and lymphatic system disorders Leukocytosis	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Investigations Lipase increased	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Mucositis oral	8.9% 5/56 • Number of events 5 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
General disorders Multi-organ failure	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Investigations Neutrophil count decreased	3.6% 2/56 • Number of events 2 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Pancreatitis	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.6% 2/56 • Number of events 2 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Nervous system disorders Seizure	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Sepsis	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Skin and subcutaneous tissue disorders Skin ulceration	5.4% 3/56 • Number of events 3 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Typhlitis	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Enterocolitis infectious	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Investigations Urine output decreased	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Rectal mucositis	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Renal and urinary disorders Acute kidney injury	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.

Other adverse events
Measure	KMT2A-Rearranged n=56 participants at risk INDUCTION: Same as KMT2A-Germline (Group 2). AZACITIDINE (AZA) I: AZA over 10-40 minutes for 5 days. CONSOLIDATION: cyclophosphamide days 1/29; mercaptopurine (6-MP) days 1-28; ARA-C days 3-6, 10-13, 17-20, 24-27; MTX IT day 24; HC days 10/24. AZA II: Same as AZA I. INTERIM MAINTENANCE: 6-MP days 1-14; MTX 1/2/8/9; leucovorin calcium days 3-4,10-11; HC days 2/9; ARA-C days 15-16, 22-23; PEG day 23. AZA III: Same as AZA I. DELAYED INTENSIFICATION (DI) I: PEG day 1; dexamethasone days 1-14, 15-21; thioguanine days 1-28; vincristine sulfate and daunorubicin hydrochloride days 1/8/15/22; ARA-C days 1-5, 9-12, 15-19, 23-26; HC on days 1/15. AZA IV: Same as AZA I. DI II: thioguanine days 1-14; cyclophosphamide days 1/15; ARA-C days 2-5, 9-12. MAINTENANCE: 6-MP days 1-168, MTX IT day 1/92; MTX weekly days 8-91,98-168; HC day 1/57/99; ARA-C day 57. Starting day 169, 6-MP days 1-84 and MTX weekly. Cycles repeat every 84 days for 2 years from start of Induction.	KMT2A-Germline n=22 participants at risk Induction: Methotrexate intrathecally (IT) on days 1 and 29, prednisolone orally (PO) or nasogastrically (NG) three times daily (TID) on days 1-7, daunorubicin hydrochloride intravenously (IV) over 1-15 minutes on days 8-9, cytarabine (ARA-C) IV over 30 minutes on days 8-21 and IT on day 15, dexamethasone PO, NG, or IV TID on days 8-28, vincristine sulfate IV over 1 minute on days 8, 15, 22, and 29, pegaspargase (PEG) IV over 1-2 hours or intramuscularly (IM) on day 12, and hydrocortisone sodium succinate (HC) IT on days 15 and 29 in the absence of disease progression or unacceptable toxicity.
Investigations Alanine aminotransferase increased	7.1% 4/56 • Number of events 6 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Metabolism and nutrition disorders Anorexia	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Respiratory, thoracic and mediastinal disorders Apnea	0.00% 0/56 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	4.5% 1/22 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Investigations Blood bilirubin increased	5.4% 3/56 • Number of events 3 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	4.5% 1/22 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Catheter related infection	7.1% 4/56 • Number of events 4 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Investigations Creatinine increased	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Blood and lymphatic system disorders Febrile neutropenia	5.4% 3/56 • Number of events 4 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	4.5% 1/22 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Metabolism and nutrition disorders Hyperglycemia	3.6% 2/56 • Number of events 3 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Metabolism and nutrition disorders Hyperkalemia	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Metabolism and nutrition disorders Hypertriglyceridemia	7.1% 4/56 • Number of events 4 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Metabolism and nutrition disorders Hypoalbuminemia	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Metabolism and nutrition disorders Hypocalcemia	5.4% 3/56 • Number of events 3 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Metabolism and nutrition disorders Hypokalemia	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	9.1% 2/22 • Number of events 2 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Infections and infestations - Other, specify	30.4% 17/56 • Number of events 37 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	18.2% 4/22 • Number of events 4 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Mucositis oral	17.9% 10/56 • Number of events 10 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	9.1% 2/22 • Number of events 2 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	0.00% 0/56 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	4.5% 1/22 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Investigations Neutrophil count decreased	3.6% 2/56 • Number of events 2 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	9.1% 2/22 • Number of events 2 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	4.5% 1/22 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Sepsis	10.7% 6/56 • Number of events 6 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	4.5% 1/22 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Sinusitis	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Skin infection	10.7% 6/56 • Number of events 8 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Skin and subcutaneous tissue disorders Skin ulceration	3.6% 2/56 • Number of events 2 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Metabolism and nutrition disorders Tumor lysis syndrome	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Upper respiratory infection	7.1% 4/56 • Number of events 5 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Urinary tract infection	3.6% 2/56 • Number of events 2 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Vascular disorders Vascular disorders - Other, specify	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Wound infection	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	4.5% 1/22 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Bronchial infection	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Investigations GGT increased	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Enterocolitis infectious	5.4% 3/56 • Number of events 4 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Lung infection	3.6% 2/56 • Number of events 2 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Soft tissue infection	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Gastrointestinal disorders Anal mucositis	3.6% 2/56 • Number of events 2 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	4.5% 1/22 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Infections and infestations Small intestine infection	1.8% 1/56 • Number of events 2 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
Renal and urinary disorders Acute kidney injury	1.8% 1/56 • Number of events 1 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.	0.00% 0/22 • Up to 5 years 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. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.