Trial Outcomes & Findings for SC-PEG Asparaginase vs. Oncaspar in Pediatric Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (NCT NCT01574274)

Last Updated: 2026-02-05

Results Overview

Asparaginase-related toxicity rate is defined as the percentage of patients who experience allergy (all grades), symptomatic pancreatitis (grade 2 or worse), thrombotic or bleeding complications requiring intervention (grade 2 or worse) with treatment attribution of possibly, probably or definite based on Common Terminology Criteria for Adverse Events (CTCAE) v4.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

240 participants

Primary outcome timeframe

30-week post-induction asparaginase treatment period. Toxicities assessed on an ongoing basis (at least 1 per month) while participant is on study, an average of 2 years.

Results posted on

2026-02-05

Participant Flow

Patients enrolled from June 3, 2012 to June 8, 2015.

Participant milestones

Participant milestones
Measure	SC-PEG (Arm A) Patients in this arm were randomized to receive IV Calaspargase Pegol (SC-PEG) 2500 IU/m2, administered as a single dose during induction and for 30 weeks post-induction. In the post-induction phases, IV SC-PEG was administered every 3 weeks (for a total of 10 post-induction doses). Protocol therapy was comprised of 5 phases: Induction, Consolidation I, Central Nervous System (CNS), Consolidation II, and Continuation, and varied based off risk classification.	Oncaspar (Arm B) Patients in this arm were randomized to receive IV Oncaspar 2500 IU/m2, administered as a single dose during induction and for 30 weeks post-induction. In the post-induction phases, IV Oncaspar was administered every 2 weeks (for a total of 15 post-induction doses). Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, and Continuation, and varied based off risk classification.
Overall Study STARTED	119	121
Overall Study Evaluable for Induction Events	115	115
Overall Study Achieved Complete Remission	109	114
Overall Study Received Post-induction Asparaginase	109	114
Overall Study Eligible	119	120
Overall Study COMPLETED	87	99
Overall Study NOT COMPLETED	32	22

Reasons for withdrawal

Reasons for withdrawal
Measure	SC-PEG (Arm A) Patients in this arm were randomized to receive IV Calaspargase Pegol (SC-PEG) 2500 IU/m2, administered as a single dose during induction and for 30 weeks post-induction. In the post-induction phases, IV SC-PEG was administered every 3 weeks (for a total of 10 post-induction doses). Protocol therapy was comprised of 5 phases: Induction, Consolidation I, Central Nervous System (CNS), Consolidation II, and Continuation, and varied based off risk classification.	Oncaspar (Arm B) Patients in this arm were randomized to receive IV Oncaspar 2500 IU/m2, administered as a single dose during induction and for 30 weeks post-induction. In the post-induction phases, IV Oncaspar was administered every 2 weeks (for a total of 15 post-induction doses). Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, and Continuation, and varied based off risk classification.
Overall Study Ineligible	0	1
Overall Study Withdrawal of Consent During Induction	1	1
Overall Study Ph+ B-ALL	3	4
Overall Study Induction Death	2	0
Overall Study Induction Failure	4	1
Overall Study Adverse Event	16	13
Overall Study Remission Death	1	0
Overall Study Withdrawal from Treatment but Agrees to be Followed	2	0
Overall Study Other, unknown	3	2

Baseline Characteristics

SC-PEG Asparaginase vs. Oncaspar in Pediatric Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SC-PEG (Arm A) n=119 Participants Patients in this arm were randomized to receive IV Calaspargase Pegol (SC-PEG) 2500 IU/m2, administered as a single dose during induction and for 30 weeks post-induction. In the post-induction phases, IV SC-PEG was administered every 3 weeks (for a total of 10 post-induction doses). Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, and Continuation, and varied based off risk classification.	Oncaspar (Arm B) n=120 Participants Patients in this arm were randomized to receive IV Oncaspar 2500 IU/m2, administered as a single dose during induction and for 30 weeks post-induction. In the post-induction phases, IV Oncaspar was administered every 2 weeks (for a total of 15 post-induction doses). Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, and Continuation, and varied based off risk classification.	Total n=239 Participants Total of all reporting groups
Age, Customized < 10 years old	89 Participants n=25 Participants	90 Participants n=26 Participants	179 Participants n=51 Participants
Age, Customized >/= 10 years old	30 Participants n=25 Participants	30 Participants n=26 Participants	60 Participants n=51 Participants
Sex: Female, Male Female	43 Participants n=25 Participants	49 Participants n=26 Participants	92 Participants n=51 Participants
Sex: Female, Male Male	76 Participants n=25 Participants	71 Participants n=26 Participants	147 Participants n=51 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=25 Participants	14 Participants n=26 Participants	26 Participants n=51 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	74 Participants n=25 Participants	77 Participants n=26 Participants	151 Participants n=51 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	33 Participants n=25 Participants	29 Participants n=26 Participants	62 Participants n=51 Participants
Immunophenotype B-immunophenotype	103 Participants n=25 Participants	104 Participants n=26 Participants	207 Participants n=51 Participants
Immunophenotype T-immunophenotype	16 Participants n=25 Participants	16 Participants n=26 Participants	32 Participants n=51 Participants
Initial Dana-Farber Cancer Institute (DFCI) risk group Standard Risk	70 Participants n=25 Participants	71 Participants n=26 Participants	141 Participants n=51 Participants
Initial Dana-Farber Cancer Institute (DFCI) risk group High Risk	49 Participants n=25 Participants	49 Participants n=26 Participants	98 Participants n=51 Participants
White Blood Cell (WBC) at diagnosis (cells/uL) < 50,000	93 Participants n=25 Participants	96 Participants n=26 Participants	189 Participants n=51 Participants
White Blood Cell (WBC) at diagnosis (cells/uL) >/= 50,000	21 Participants n=25 Participants	20 Participants n=26 Participants	41 Participants n=51 Participants
White Blood Cell (WBC) at diagnosis (cells/uL) Missing	5 Participants n=25 Participants	4 Participants n=26 Participants	9 Participants n=51 Participants
CNS status at diagnosis CNS 1	90 Participants n=25 Participants	99 Participants n=26 Participants	189 Participants n=51 Participants
CNS status at diagnosis CNS 2	19 Participants n=25 Participants	15 Participants n=26 Participants	34 Participants n=51 Participants
CNS status at diagnosis CNS 3	1 Participants n=25 Participants	3 Participants n=26 Participants	4 Participants n=51 Participants
CNS status at diagnosis Traumatic with Blasts	3 Participants n=25 Participants	2 Participants n=26 Participants	5 Participants n=51 Participants
CNS status at diagnosis Traumatic without Blasts	6 Participants n=25 Participants	1 Participants n=26 Participants	7 Participants n=51 Participants

PRIMARY outcome

Timeframe: 30-week post-induction asparaginase treatment period. Toxicities assessed on an ongoing basis (at least 1 per month) while participant is on study, an average of 2 years.

Population: The analysis dataset is comprised of all patients who received post-induction asparaginase.

Outcome measures

Outcome measures
Measure	Oncaspar (Arm B) n=114 Participants Patients in this arm were randomized to receive IV Oncaspar 2500 IU/m2, administered as a single dose during induction and for 30 weeks post-induction. In the post-induction phases, IV Oncaspar was administered every 2 weeks (for a total of 15 post-induction doses). Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, and Continuation, and varied based off risk classification.	SC-PEG (Arm A) n=109 Participants Patients in this arm were randomized to receive IV Calaspargase Pegol (SC-PEG) 2500 IU/m2, administered as a single dose during induction and for 30 weeks post-induction. In the post-induction phases, IV SC-PEG was administered every 3 weeks (for a total of 10 post-induction doses). Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, and Continuation, and varied based off risk classification.
Number of Participants With Asparaginase-Related Toxicity	43 Participants	41 Participants

PRIMARY outcome

Timeframe: Samples for nadir serum asparaginase activity levels were assayed at 4,11,18,and 25 days after 1st dose, and then prior to asparaginase dose given during post-induction, at Week 7, 13, 19, and 25.

Population: The analysis dataset is comprised of all randomized patients who consented to research studies with an evaluable sample for analysis of serum asparaginase activity at the respective induction and post-induction assessment timepoints.

Nadir serum asparaginase activity (NSAA) levels were estimated based on established methods.

Outcome measures

Outcome measures
Measure	Oncaspar (Arm B) n=120 Participants Patients in this arm were randomized to receive IV Oncaspar 2500 IU/m2, administered as a single dose during induction and for 30 weeks post-induction. In the post-induction phases, IV Oncaspar was administered every 2 weeks (for a total of 15 post-induction doses). Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, and Continuation, and varied based off risk classification.	SC-PEG (Arm A) n=119 Participants Patients in this arm were randomized to receive IV Calaspargase Pegol (SC-PEG) 2500 IU/m2, administered as a single dose during induction and for 30 weeks post-induction. In the post-induction phases, IV SC-PEG was administered every 3 weeks (for a total of 10 post-induction doses). Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, and Continuation, and varied based off risk classification.
Induction and Post-Induction Nadir Serum Asparaginase Activity Level Week 13 NSAA Level	1.101 IU/mL Interval 0.512 to 1.866	1.147 IU/mL Interval 0.143 to 2.181
Induction and Post-Induction Nadir Serum Asparaginase Activity Level Week 19 NSAA Level	1.134 IU/mL Interval 0.508 to 1.82	1.110 IU/mL Interval 0.318 to 2.709
Induction and Post-Induction Nadir Serum Asparaginase Activity Level Week 25 NSAA Level	1.109 IU/mL Interval 0.483 to 1.814	1.117 IU/mL Interval 0.153 to 2.106
Induction and Post-Induction Nadir Serum Asparaginase Activity Level Day 11 NSAA Level	0.673 IU/mL Interval 0.025 to 1.224	0.571 IU/mL Interval 0.156 to 1.176
Induction and Post-Induction Nadir Serum Asparaginase Activity Level Day 18 NSAA Level	0.314 IU/mL Interval 0.025 to 0.536	0.394 IU/mL Interval 0.08 to 0.887
Induction and Post-Induction Nadir Serum Asparaginase Activity Level Day 25 NSAA Level	0.056 IU/mL Interval 0.025 to 0.079	0.319 IU/mL Interval 0.025 to 0.549
Induction and Post-Induction Nadir Serum Asparaginase Activity Level Week 7 NSAA Level	1.097 IU/mL Interval 0.506 to 1.814	1.006 IU/mL Interval 0.025 to 1.948
Induction and Post-Induction Nadir Serum Asparaginase Activity Level Day 4 NSAA Level	1.045 IU/mL Interval 0.069 to 1.731	0.975 IU/mL Interval 0.43 to 1.499

SECONDARY outcome

Timeframe: 2 years

Number of episodes of bacteremia, fungemia and invasive fungal infections during the remission induction phase

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Rates of complete remission, relapse, induction death, remission death, and second malignant neoplasms in participants

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Rates of relapse, remission death and second malignant neoplasm in participants with high minimal residual disease (MRD) and/or high risk cytogenetics who are treated with a more intensified regimen

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Vitamin D-levels at various times during treatment, proportion of participants with low vitamin D levels, proportion of participants who agree to Vitamin D supplementation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Number of samples from participants with T-ALL in which a successful result was obtained by quantitative polymerase chain reaction (qPCR) to assess absence of biallelic TCRy deletions (ABGD); frequency of ABGD in T-ALL

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Number of samples from participants with B-ALL in which a successful result was obtained in prospective screening for abnormalities (eg, mutations, deletions, rearrangements) of IKZF1, CRLF2 and JAK1/2 in patients with newly diagnosed B-ALL; proportion of participants with B-ALL found to have one of these abnormalities.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Levels of pro- and anti-apoptotic proteins in participant samples from diagnosis; correlation of these levels to clinical response (induction failure, high MRD, relapse).

Outcome measures

Outcome data not reported

Adverse Events

SC-PEG (Arm A)

Serious events: 35 serious events

Other events: 118 other events

Deaths: 7 deaths

Oncaspar (Arm B)

Serious events: 27 serious events

Other events: 120 other events

Deaths: 5 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Lewis Silverman

Dana-Farber Cancer Institute

Phone: 16176326191

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	SC-PEG (Arm A) n=119 participants at risk Patients in this arm were randomized to receive IV Calaspargase Pegol (SC-PEG) 2500 IU/m2, administered as a single dose during induction and for 30 weeks post-induction. In the post-induction phases, IV SC-PEG was administered every 3 weeks (for a total of 10 post-induction doses). Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, and Continuation, and varied based off risk classification.	Oncaspar (Arm B) n=120 participants at risk Patients in this arm were randomized to receive IV Oncaspar 2500 IU/m2, administered as a single dose during induction and for 30 weeks post-induction. In the post-induction phases, IV Oncaspar was administered every 2 weeks (for a total of 15 post-induction doses). Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, and Continuation, and varied based off risk classification.
Blood and lymphatic system disorders Disseminated intravascular coagulation	1.7% 2/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.00% 0/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.83% 1/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Cardiac disorders Atrioventricular block complete	0.84% 1/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.00% 0/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Ear and labyrinth disorders Hearing impaired	0.84% 1/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.00% 0/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Eye disorders Eye disorders - Other, specify	0.84% 1/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.00% 0/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Gastrointestinal disorders Abdominal pain	0.84% 1/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.00% 0/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Gastrointestinal disorders Colitis	0.84% 1/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.00% 0/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Gastrointestinal disorders Diarrhea	0.00% 0/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.83% 1/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Gastrointestinal disorders Duodenal hemorrhage	0.00% 0/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.83% 1/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Gastrointestinal disorders Enterocolitis	0.84% 1/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.00% 0/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Gastrointestinal disorders Mucositis oral	0.84% 1/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.00% 0/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Gastrointestinal disorders Pancreatitis	8.4% 10/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	5.0% 6/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Gastrointestinal disorders Small intestinal obstruction	0.84% 1/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.00% 0/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Gastrointestinal disorders Typhlitis	0.84% 1/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.00% 0/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.00% 0/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.83% 1/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
General disorders Edema trunk	0.84% 1/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.00% 0/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
General disorders Fever	0.84% 1/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.00% 0/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	1.7% 2/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.00% 0/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Hepatobiliary disorders Portal vein thrombosis	0.84% 1/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.00% 0/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Infections and infestations Appendicitis perforated	0.84% 1/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.00% 0/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Infections and infestations Catheter related infection	0.84% 1/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.00% 0/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Infections and infestations Infections and infestations - Other, specify	3.4% 4/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.83% 1/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Infections and infestations Lung infection	2.5% 3/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.83% 1/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Infections and infestations Pleural infection	0.00% 0/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.83% 1/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Infections and infestations Sepsis	3.4% 4/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	7.5% 9/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Infections and infestations Upper respiratory infection	0.84% 1/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.00% 0/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Injury, poisoning and procedural complications Fracture	0.00% 0/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.83% 1/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	0.84% 1/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.00% 0/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Investigations Alanine aminotransferase increased	3.4% 4/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.83% 1/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Investigations Aspartate aminotransferase increased	3.4% 4/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.00% 0/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Investigations Blood bilirubin increased	4.2% 5/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	1.7% 2/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Investigations Creatinine increased	0.84% 1/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.00% 0/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Investigations Lipase increased	5.0% 6/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	10.0% 12/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Investigations Serum amylase increased	2.5% 3/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	4.2% 5/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Metabolism and nutrition disorders Acidosis	0.00% 0/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.83% 1/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Metabolism and nutrition disorders Hyperglycemia	4.2% 5/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	3.3% 4/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Metabolism and nutrition disorders Hypertriglyceridemia	0.84% 1/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.83% 1/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.83% 1/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Metabolism and nutrition disorders Tumor lysis syndrome	0.84% 1/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.00% 0/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.83% 1/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.

Other adverse events
Measure	SC-PEG (Arm A) n=119 participants at risk Patients in this arm were randomized to receive IV Calaspargase Pegol (SC-PEG) 2500 IU/m2, administered as a single dose during induction and for 30 weeks post-induction. In the post-induction phases, IV SC-PEG was administered every 3 weeks (for a total of 10 post-induction doses). Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, and Continuation, and varied based off risk classification.	Oncaspar (Arm B) n=120 participants at risk Patients in this arm were randomized to receive IV Oncaspar 2500 IU/m2, administered as a single dose during induction and for 30 weeks post-induction. In the post-induction phases, IV Oncaspar was administered every 2 weeks (for a total of 15 post-induction doses). Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, and Continuation, and varied based off risk classification.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.84% 1/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.00% 0/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Blood and lymphatic system disorders Febrile neutropenia	46.2% 55/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	47.5% 57/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Cardiac disorders Cardiac disorders - Other, specify	0.84% 1/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.00% 0/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Cardiac disorders Left ventricular systolic dysfunction	1.7% 2/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.00% 0/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Cardiac disorders Sinus tachycardia	2.5% 3/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	1.7% 2/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Cardiac disorders Ventricular arrhythmia	0.84% 1/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.83% 1/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Ear and labyrinth disorders External ear inflammation	0.84% 1/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.00% 0/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Endocrine disorders Adrenal insufficiency	0.00% 0/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.83% 1/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Eye disorders Optic nerve disorder	0.00% 0/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.83% 1/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Gastrointestinal disorders Abdominal pain	2.5% 3/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.83% 1/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Gastrointestinal disorders Anal mucositis	1.7% 2/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	1.7% 2/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Gastrointestinal disorders Ascites	1.7% 2/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	1.7% 2/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Gastrointestinal disorders Colitis	0.84% 1/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.00% 0/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Gastrointestinal disorders Duodenal hemorrhage	0.00% 0/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.83% 1/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Gastrointestinal disorders Enterocolitis	0.84% 1/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	1.7% 2/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Gastrointestinal disorders Esophageal ulcer	0.00% 0/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.83% 1/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Gastrointestinal disorders Esophagitis	0.84% 1/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.00% 0/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	0.84% 1/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	1.7% 2/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Gastrointestinal disorders Ileus	0.84% 1/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	1.7% 2/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Gastrointestinal disorders Intra-abdominal hemorrhage	0.00% 0/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.83% 1/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.84% 1/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.00% 0/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Gastrointestinal disorders Mucositis oral	27.7% 33/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	20.0% 24/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Gastrointestinal disorders Nausea	0.84% 1/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.00% 0/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Gastrointestinal disorders Pancreatic necrosis	0.84% 1/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.00% 0/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Gastrointestinal disorders Pancreatitis	11.8% 14/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	12.5% 15/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Gastrointestinal disorders Rectal mucositis	0.00% 0/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	1.7% 2/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Gastrointestinal disorders Rectal pain	0.00% 0/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.83% 1/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Gastrointestinal disorders Typhlitis	7.6% 9/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	2.5% 3/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
General disorders Edema limbs	0.84% 1/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.00% 0/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
General disorders Fever	0.00% 0/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.83% 1/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
General disorders General disorders and administration site conditions - Other, specify	0.00% 0/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.83% 1/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
General disorders Infusion related reaction	0.00% 0/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	1.7% 2/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
General disorders Infusion site extravasation	0.84% 1/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.00% 0/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
General disorders Injection site reaction	0.00% 0/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.83% 1/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
General disorders Irritability	0.00% 0/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.83% 1/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
General disorders Localized edema	0.84% 1/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.00% 0/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
General disorders Pain	0.00% 0/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	1.7% 2/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	1.7% 2/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.00% 0/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Hepatobiliary disorders Portal hypertension	0.00% 0/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.83% 1/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/119 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.	0.83% 1/120 • Adverse events (AE) were continuously monitored and recorded prior to each course of therapy, for the duration of prophase, induction, and the total planned post-induction treatment of 24 months from complete remission (CR) date. Treatment duration for this study cohort was a median (range) of 769 days (3-797 days). AE assessment was performed at least 1x per month through the end of the Consolidation II phase, and at least 1x per 3 months during the Continuation phase, for a max of 797 days. AEs were collected by grade and treatment attribution, and max grade by toxicity type was calculated. Serious AEs were identified separately, and were defined as any adverse drug experience that resulted in any of the following: death, a life-threatening event, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. All remaining adverse events, regardless of attribution, were classified as Other AEs.