Trial Outcomes & Findings for Vincristine Sulfate Liposome Injection (Marqibo®) in Combination With UK ALL R3 Induction Chemotherapy (NCT NCT02879643)

Last Updated: 2025-10-22

Results Overview

Number of Participants with Dose Limiting Toxicities as a Measure of Safety and Tolerability at different dose levels of Marqibo. Dose Level 1 = 1.5 mg/m\^2. Dose Level 2 = 2.0 mg/m\^2. Cohort A and B accrued at both Dose Levels. Cohort C accrued only at Dose Level 2.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

29 participants

Primary outcome timeframe

9 weeks

Results posted on

2025-10-22

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort A Dose Level 1: Marqibo and UK ALL R3 Backbone * Marqibo® (1.5 mg/m\^2): given by intravenous (IV) infusion on days 1, 8, 15 and 22. * Dexamethasone orally twice daily on days 1-5 and 15-19. * Mitoxantrone: given by intravenous (IV) infusion on days 1 and 2. * PEG-asparaginase: given as an injection into the muscle on says 3 and 17. * Methotrexate IT: given intrathecally (used to treat the brain and spinal cord and is given using a needle inserted into the spinal canal) on days 1 and 8. Marqibo: The focus of the study design and statistical analysis is to determine whether Marqibo® can be substituted for standard vincristine and successfully administered to patients with relapsed ALL in three different treatment cohorts: (A) treatment with the UK ALL R3 regimen; (B) treatment with UK ALL R3 regimen without mitoxantrone, and (C) treatment with ALL maintenance therapy. Secondary objectives include estimating rates of serious toxicities and therapy delays in each of these cohorts.	Cohort A Dose Level 2: Marqibo and UKALL R3 Backbone Marqibo® (2.0 mg/m\^2): given byintravenous (IV)infusion on days 1, 8,15 and 22. Dexamethasone orallytwice daily on days 1-5and 15-19. Mitoxantrone: given byintravenous (IV)infusion on days 1 and2. PEG-asparaginase:given as an injectioninto the muscle on says3 and 17. Methotrexate IT: givenintrathecally (used totreat the brain andspinal cord and is givenusing a needle insertedinto the spinal canal) ondays 1 and 8. Marqibo: The focus of thestudy design and statisticalanalysis is to determinewhether Marqibo® can besubstituted for standardvincristine and successfullyadministered to patients withrelapsed ALL in threedifferent treatment cohorts:(A) treatment with the UK ALLR3 regimen; (B) treatmentwith UK ALL R3 regimenwithout mitoxantrone, and (C)treatment with ALLmaintenance therapy.Secondary objectives includeestimating rates of serioustoxicities and therapy delaysin each of these cohorts.	Cohort B Dose Level 1: Marqibo and Lower Intensity UK ALL R3 Backbone * Marqibo® (1.5 mg/m\^2): given by intravenous (IV) infusion on days 1, 8, 15 and 22. * Dexamethasone orally twice daily on days 1-5 and 15-19. * PEG-asparaginase: given as an injection into the muscle on days 3 and 17. * Methotrexate IT: given intrathecally (used to treat the brain and spinal cord and is given using a needle inserted into the spinal canal) on days 1 and 8. Marqibo: The focus of the study design and statistical analysis is to determine whether Marqibo® can be substituted for standard vincristine and successfully administered to patients with relapsed ALL in three different treatment cohorts: (A) treatment with the UK ALL R3 regimen; (B) treatment with UK ALL R3 regimen without mitoxantrone, and (C) treatment with ALL maintenance therapy. Secondary objectives include estimating rates of serious toxicities and therapy delays in each of these cohorts.	Cohort B Dose Level 2: Marqibo and LowerIntensity UK ALL R3Backbone Marqibo® (2.0 mg/m\^2): given byintravenous (IV)infusion on days 1, 8,15 and 22. Dexamethasone orallytwice daily on days 1-5and 15-19. PEG-asparaginase:given as an injectioninto the muscle on days3 and 17. Methotrexate IT: givenintrathecally (used totreat the brain andspinal cord and is givenusing a needle insertedinto the spinal canal) ondays 1 and 8. Marqibo: The focus of thestudy design and statisticalanalysis is to determinewhether Marqibo® can besubstituted for standardvincristine and successfullyadministered to patients withrelapsed ALL in threedifferent treatment cohorts:(A) treatment with the UK ALLR3 regimen; (B) treatmentwith UK ALL R3 regimenwithout mitoxantrone, and (C)treatment with ALLmaintenance therapy.Secondary objectives includeestimating rates of serioustoxicities and therapy delaysin each of these cohorts.	Cohort C Dose Level 2: Marqibo and Maintenance Regimen * Marqibo®(2.0 mg/m\^2): given by intravenous (IV) infusion on day 1 * Dexamethasone orally twice daily on days 1-5 * Methotrexate: given orally on days 1 and 8 * Mercaptopurine: given orally daily on days 1-13 Marqibo: The focus of the study design and statistical analysis is to determine whether Marqibo® can be substituted for standard vincristine and successfully administered to patients with relapsed ALL in three different treatment cohorts: (A) treatment with the UK ALL R3 regimen; (B) treatment with UK ALL R3 regimen without mitoxantrone, and (C) treatment with ALL maintenance therapy. Secondary objectives include estimating rates of serious toxicities and therapy delays in each of these cohorts.
Overall Study STARTED	12	4	6	2	5
Overall Study COMPLETED	12	4	5	1	5
Overall Study NOT COMPLETED	0	0	1	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort A Dose Level 1: Marqibo and UK ALL R3 Backbone * Marqibo® (1.5 mg/m\^2): given by intravenous (IV) infusion on days 1, 8, 15 and 22. * Dexamethasone orally twice daily on days 1-5 and 15-19. * Mitoxantrone: given by intravenous (IV) infusion on days 1 and 2. * PEG-asparaginase: given as an injection into the muscle on says 3 and 17. * Methotrexate IT: given intrathecally (used to treat the brain and spinal cord and is given using a needle inserted into the spinal canal) on days 1 and 8. Marqibo: The focus of the study design and statistical analysis is to determine whether Marqibo® can be substituted for standard vincristine and successfully administered to patients with relapsed ALL in three different treatment cohorts: (A) treatment with the UK ALL R3 regimen; (B) treatment with UK ALL R3 regimen without mitoxantrone, and (C) treatment with ALL maintenance therapy. Secondary objectives include estimating rates of serious toxicities and therapy delays in each of these cohorts.	Cohort A Dose Level 2: Marqibo and UKALL R3 Backbone Marqibo® (2.0 mg/m\^2): given byintravenous (IV)infusion on days 1, 8,15 and 22. Dexamethasone orallytwice daily on days 1-5and 15-19. Mitoxantrone: given byintravenous (IV)infusion on days 1 and2. PEG-asparaginase:given as an injectioninto the muscle on says3 and 17. Methotrexate IT: givenintrathecally (used totreat the brain andspinal cord and is givenusing a needle insertedinto the spinal canal) ondays 1 and 8. Marqibo: The focus of thestudy design and statisticalanalysis is to determinewhether Marqibo® can besubstituted for standardvincristine and successfullyadministered to patients withrelapsed ALL in threedifferent treatment cohorts:(A) treatment with the UK ALLR3 regimen; (B) treatmentwith UK ALL R3 regimenwithout mitoxantrone, and (C)treatment with ALLmaintenance therapy.Secondary objectives includeestimating rates of serioustoxicities and therapy delaysin each of these cohorts.	Cohort B Dose Level 1: Marqibo and Lower Intensity UK ALL R3 Backbone * Marqibo® (1.5 mg/m\^2): given by intravenous (IV) infusion on days 1, 8, 15 and 22. * Dexamethasone orally twice daily on days 1-5 and 15-19. * PEG-asparaginase: given as an injection into the muscle on days 3 and 17. * Methotrexate IT: given intrathecally (used to treat the brain and spinal cord and is given using a needle inserted into the spinal canal) on days 1 and 8. Marqibo: The focus of the study design and statistical analysis is to determine whether Marqibo® can be substituted for standard vincristine and successfully administered to patients with relapsed ALL in three different treatment cohorts: (A) treatment with the UK ALL R3 regimen; (B) treatment with UK ALL R3 regimen without mitoxantrone, and (C) treatment with ALL maintenance therapy. Secondary objectives include estimating rates of serious toxicities and therapy delays in each of these cohorts.	Cohort B Dose Level 2: Marqibo and LowerIntensity UK ALL R3Backbone Marqibo® (2.0 mg/m\^2): given byintravenous (IV)infusion on days 1, 8,15 and 22. Dexamethasone orallytwice daily on days 1-5and 15-19. PEG-asparaginase:given as an injectioninto the muscle on days3 and 17. Methotrexate IT: givenintrathecally (used totreat the brain andspinal cord and is givenusing a needle insertedinto the spinal canal) ondays 1 and 8. Marqibo: The focus of thestudy design and statisticalanalysis is to determinewhether Marqibo® can besubstituted for standardvincristine and successfullyadministered to patients withrelapsed ALL in threedifferent treatment cohorts:(A) treatment with the UK ALLR3 regimen; (B) treatmentwith UK ALL R3 regimenwithout mitoxantrone, and (C)treatment with ALLmaintenance therapy.Secondary objectives includeestimating rates of serioustoxicities and therapy delaysin each of these cohorts.	Cohort C Dose Level 2: Marqibo and Maintenance Regimen * Marqibo®(2.0 mg/m\^2): given by intravenous (IV) infusion on day 1 * Dexamethasone orally twice daily on days 1-5 * Methotrexate: given orally on days 1 and 8 * Mercaptopurine: given orally daily on days 1-13 Marqibo: The focus of the study design and statistical analysis is to determine whether Marqibo® can be substituted for standard vincristine and successfully administered to patients with relapsed ALL in three different treatment cohorts: (A) treatment with the UK ALL R3 regimen; (B) treatment with UK ALL R3 regimen without mitoxantrone, and (C) treatment with ALL maintenance therapy. Secondary objectives include estimating rates of serious toxicities and therapy delays in each of these cohorts.
Overall Study Adverse Event	0	0	1	1	0

Baseline Characteristics

Vincristine Sulfate Liposome Injection (Marqibo®) in Combination With UK ALL R3 Induction Chemotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A Dose Level 1: Marqibo and UK ALL R3 Backbone n=12 Participants * Marqibo® (1.5 mg/m\^2): given by intravenous (IV) infusion on days 1, 8, 15 and 22. * Dexamethasone orally twice daily on days 1-5 and 15-19. * Mitoxantrone: given by intravenous (IV) infusion on days 1 and 2. * PEG-asparaginase: given as an injection into the muscle on says 3 and 17. * Methotrexate IT: given intrathecally (used to treat the brain and spinal cord and is given using a needle inserted into the spinal canal) on days 1 and 8. Marqibo: The focus of the study design and statistical analysis is to determine whether Marqibo® can be substituted for standard vincristine and successfully administered to patients with relapsed ALL in three different treatment cohorts: (A) treatment with the UK ALL R3 regimen; (B) treatment with UK ALL R3 regimen without mitoxantrone, and (C) treatment with ALL maintenance therapy. Secondary objectives include estimating rates of serious toxicities and therapy delays in each of these cohorts.	Cohort A Dose Level 2: Marqibo and UK ALL R3 Backbone n=4 Participants * Marqibo® (2.0 mg/m\^2): given by intravenous (IV) infusion on days 1, 8, 15 and 22. * Dexamethasone orally twice daily on days 1-5 and 15-19. * Mitoxantrone: given by intravenous (IV) infusion on days 1 and 2. * PEG-asparaginase: given as an injection into the muscle on says 3 and 17. * Methotrexate IT: given intrathecally (used to treat the brain and spinal cord and is given using a needle inserted into the spinal canal) on days 1 and 8. Marqibo: The focus of the study design and statistical analysis is to determine whether Marqibo® can be substituted for standard vincristine and successfully administered to patients with relapsed ALL in three different treatment cohorts: (A) treatment with the UK ALL R3 regimen; (B) treatment with UK ALL R3 regimen without mitoxantrone, and (C) treatment with ALL maintenance therapy. Secondary objectives include estimating rates of serious toxicities and therapy delays in each of these cohorts.	Cohort B Dose Level 1: Marqibo and Lower Intensity UK ALL R3 Backbone n=6 Participants * Marqibo® (1.5 mg/m\^2): given by intravenous (IV) infusion on days 1, 8, 15 and 22. * Dexamethasone orally twice daily on days 1-5 and 15-19. * PEG-asparaginase: given as an injection into the muscle on days 3 and 17. * Methotrexate IT: given intrathecally (used to treat the brain and spinal cord and is given using a needle inserted into the spinal canal) on days 1 and 8. Marqibo: The focus of the study design and statistical analysis is to determine whether Marqibo® can be substituted for standard vincristine and successfully administered to patients with relapsed ALL in three different treatment cohorts: (A) treatment with the UK ALL R3 regimen; (B) treatment with UK ALL R3 regimen without mitoxantrone, and (C) treatment with ALL maintenance therapy. Secondary objectives include estimating rates of serious toxicities and therapy delays in each of these cohorts.	Cohort B Dose Level 2: Marqibo and Lower Intensity UK ALL R3 Backbone n=2 Participants * Marqibo® (2.0 mg/m\^2): given by intravenous (IV) infusion on days 1, 8, 15 and 22. * Dexamethasone orally twice daily on days 1-5 and 15-19. * PEG-asparaginase: given as an injection into the muscle on days 3 and 17. * Methotrexate IT: given intrathecally (used to treat the brain and spinal cord and is given using a needle inserted into the spinal canal) on days 1 and 8. Marqibo: The focus of the study design and statistical analysis is to determine whether Marqibo® can be substituted for standard vincristine and successfully administered to patients with relapsed ALL in three different treatment cohorts: (A) treatment with the UK ALL R3 regimen; (B) treatment with UK ALL R3 regimen without mitoxantrone, and (C) treatment with ALL maintenance therapy. Secondary objectives include estimating rates of serious toxicities and therapy delays in each of these cohorts.	Cohort C Dose Level 2: Marqibo and Maintenance Regimen n=5 Participants * Marqibo® (2.0 mg/m\^2): given by intravenous (IV) infusion on day 1 * Dexamethasone orally twice daily on days 1-5 * Methotrexate: given orally on days 1 and 8 * Mercaptopurine: given orally daily on days 1-13 Marqibo: The focus of the study design and statistical analysis is to determine whether Marqibo® can be substituted for standard vincristine and successfully administered to patients with relapsed ALL in three different treatment cohorts: (A) treatment with the UK ALL R3 regimen; (B) treatment with UK ALL R3 regimen without mitoxantrone, and (C) treatment with ALL maintenance therapy. Secondary objectives include estimating rates of serious toxicities and therapy delays in each of these cohorts.	Total n=29 Participants Total of all reporting groups
Age, Categorical <=18 years	12 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	27 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Age, Continuous	12.3 years n=5 Participants	8.7 years n=7 Participants	12 years n=5 Participants	12.7 years n=4 Participants	15.8 years n=21 Participants	12.4 years n=10 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	12 Participants n=10 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	17 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	20 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	6 Participants n=10 Participants
Region of Enrollment United States	12 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants	2 participants n=4 Participants	5 participants n=21 Participants	29 participants n=10 Participants

PRIMARY outcome

Timeframe: 9 weeks

Outcome measures

Outcome measures
Measure	Cohort A Dose Level 1: Marqibo and UK ALL R3 Backbone n=12 Participants * Marqibo®(1.5 mg/m\^2): given by intravenous (IV) infusion on days 1, 8, 15 and 22. * Dexamethasone orally twice daily on days 1-5 and 15-19. * Mitoxantrone: given by intravenous (IV) infusion on days 1 and 2. * PEG-asparaginase: given as an injection into the muscle on says 3 and 17. * Methotrexate IT: given intrathecally (used to treat the brain and spinal cord and is given using a needle inserted into the spinal canal) on days 1 and 8. Marqibo: The focus of the study design and statistical analysis is to determine whether Marqibo® can be substituted for standard vincristine and successfully administered to patients with relapsed ALL in three different treatment cohorts: (A) treatment with the UK ALL R3 regimen; (B) treatment with UK ALL R3 regimen without mitoxantrone, and (C) treatment with ALL maintenance therapy. Secondary objectives include estimating rates of serious toxicities and therapy delays in each of these cohorts.	Cohort A Dose Level 2: Marqibo and UK ALL R3 Backbone n=4 Participants * Marqibo®(2.0 mg/m\^2): given by intravenous (IV) infusion on days 1, 8, 15 and 22. * Dexamethasone orally twice daily on days 1-5 and 15-19. * Mitoxantrone: given by intravenous (IV) infusion on days 1 and 2. * PEG-asparaginase: given as an injection into the muscle on says 3 and 17. * Methotrexate IT: given intrathecally (used to treat the brain and spinal cord and is given using a needle inserted into the spinal canal) on days 1 and 8. Marqibo: The focus of the study design and statistical analysis is to determine whether Marqibo® can be substituted for standard vincristine and successfully administered to patients with relapsed ALL in three different treatment cohorts: (A) treatment with the UK ALL R3 regimen; (B) treatment with UK ALL R3 regimen without mitoxantrone, and (C) treatment with ALL maintenance therapy. Secondary objectives include estimating rates of serious toxicities and therapy delays in each of these cohorts.	Cohort B Dose Level 1: Marqibo and Lower Intensity UK ALL R3 Backbone n=6 Participants * Marqibo®(1.5 mg/m\^2): given by intravenous (IV) infusion on days 1, 8, 15 and 22. * Dexamethasone orally twice daily on days 1-5 and 15-19. * PEG-asparaginase: given as an injection into the muscle on days 3 and 17. * Methotrexate IT: given intrathecally (used to treat the brain and spinal cord and is given using a needle inserted into the spinal canal) on days 1 and 8. Marqibo: The focus of the study design and statistical analysis is to determine whether Marqibo® can be substituted for standard vincristine and successfully administered to patients with relapsed ALL in three different treatment cohorts: (A) treatment with the UK ALL R3 regimen; (B) treatment with UK ALL R3 regimen without mitoxantrone, and (C) treatment with ALL maintenance therapy. Secondary objectives include estimating rates of serious toxicities and therapy delays in each of these cohorts.	Cohort B Dose Level 2: Marqibo and Lower Intensity UK ALL R3 Backbone n=2 Participants * Marqibo®(2.0 mg/m\^2): given by intravenous (IV) infusion on days 1, 8, 15 and 22. * Dexamethasone orally twice daily on days 1-5 and 15-19. * PEG-asparaginase: given as an injection into the muscle on days 3 and 17. * Methotrexate IT: given intrathecally (used to treat the brain and spinal cord and is given using a needle inserted into the spinal canal) on days 1 and 8. Marqibo: The focus of the study design and statistical analysis is to determine whether Marqibo® can be substituted for standard vincristine and successfully administered to patients with relapsed ALL in three different treatment cohorts: (A) treatment with the UK ALL R3 regimen; (B) treatment with UK ALL R3 regimen without mitoxantrone, and (C) treatment with ALL maintenance therapy. Secondary objectives include estimating rates of serious toxicities and therapy delays in each of these cohorts.	Cohort C Dose Level 2: Marqibo and Maintenance Regimen n=5 Participants * Marqibo®(2.0 mg/m\^2): given by intravenous (IV) infusion on day 1 * Dexamethasone orally twice daily on days 1-5 * Methotrexate: given orally on days 1 and 8 * Mercaptopurine: given orally daily on days 1-13 Marqibo: The focus of the study design and statistical analysis is to determine whether Marqibo® can be substituted for standard vincristine and successfully administered to patients with relapsed ALL in three different treatment cohorts: (A) treatment with the UK ALL R3 regimen; (B) treatment with UK ALL R3 regimen without mitoxantrone, and (C) treatment with ALL maintenance therapy. Secondary objectives include estimating rates of serious toxicities and therapy delays in each of these cohorts.
Number of Participants With Dose Limiting Toxicities as a Measure of Safety and Tolerability No DLT	12 Participants	2 Participants	6 Participants	1 Participants	5 Participants
Number of Participants With Dose Limiting Toxicities as a Measure of Safety and Tolerability DLT	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants

Adverse Events

Cohort A Dose Level 1: Marqibo and UK ALL R3 Backbone

Serious events: 7 serious events

Other events: 12 other events

Deaths: 0 deaths

Cohort A Dose Level 2: Marqibo and UK ALL R3 Backbone

Serious events: 4 serious events

Other events: 4 other events

Deaths: 0 deaths

Cohort B Dose Level 1: Marqibo and Lower Intensity UK ALL R3 Backbone

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Cohort B Dose Level 2: Marqibo and Lower Intensity UK ALL R3 Backbone

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Cohort C: Marqibo and Maintenance Regimen

Serious events: 5 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort A Dose Level 1: Marqibo and UK ALL R3 Backbone n=12 participants at risk * Marqibo®: given by intravenous (IV) infusion on days 1, 8, 15 and 22. * Dexamethasone orally twice daily on days 1-5 and 15-19. * Mitoxantrone: given by intravenous (IV) infusion on days 1 and 2. * PEG-asparaginase: given as an injection into the muscle on says 3 and 17. * Methotrexate IT: given intrathecally (used to treat the brain and spinal cord and is given using a needle inserted into the spinal canal) on days 1 and 8. Marqibo: The focus of the study design and statistical analysis is to determine whether Marqibo® can be substituted for standard vincristine and successfully administered to patients with relapsed ALL in three different treatment cohorts: (A) treatment with the UK ALL R3 regimen; (B) treatment with UK ALL R3 regimen without mitoxantrone, and (C) treatment with ALL maintenance therapy. Secondary objectives include estimating rates of serious toxicities and therapy delays in each of these cohorts.	Cohort A Dose Level 2: Marqibo and UK ALL R3 Backbone n=4 participants at risk * Marqibo®: given by intravenous (IV) infusion on days 1, 8, 15 and 22. * Dexamethasone orally twice daily on days 1-5 and 15-19. * Mitoxantrone: given by intravenous (IV) infusion on days 1 and 2. * PEG-asparaginase: given as an injection into the muscle on says 3 and 17. * Methotrexate IT: given intrathecally (used to treat the brain and spinal cord and is given using a needle inserted into the spinal canal) on days 1 and 8. Marqibo: The focus of the study design and statistical analysis is to determine whether Marqibo® can be substituted for standard vincristine and successfully administered to patients with relapsed ALL in three different treatment cohorts: (A) treatment with the UK ALL R3 regimen; (B) treatment with UK ALL R3 regimen without mitoxantrone, and (C) treatment with ALL maintenance therapy. Secondary objectives include estimating rates of serious toxicities and therapy delays in each of these cohorts.	Cohort B Dose Level 1: Marqibo and Lower Intensity UK ALL R3 Backbone n=6 participants at risk * Marqibo®: given by intravenous (IV) infusion on days 1, 8, 15 and 22. * Dexamethasone orally twice daily on days 1-5 and 15-19. * PEG-asparaginase: given as an injection into the muscle on days 3 and 17. * Methotrexate IT: given intrathecally (used to treat the brain and spinal cord and is given using a needle inserted into the spinal canal) on days 1 and 8. Marqibo: The focus of the study design and statistical analysis is to determine whether Marqibo® can be substituted for standard vincristine and successfully administered to patients with relapsed ALL in three different treatment cohorts: (A) treatment with the UK ALL R3 regimen; (B) treatment with UK ALL R3 regimen without mitoxantrone, and (C) treatment with ALL maintenance therapy. Secondary objectives include estimating rates of serious toxicities and therapy delays in each of these cohorts.	Cohort B Dose Level 2: Marqibo and Lower Intensity UK ALL R3 Backbone n=2 participants at risk * Marqibo®: given by intravenous (IV) infusion on days 1, 8, 15 and 22. * Dexamethasone orally twice daily on days 1-5 and 15-19. * PEG-asparaginase: given as an injection into the muscle on days 3 and 17. * Methotrexate IT: given intrathecally (used to treat the brain and spinal cord and is given using a needle inserted into the spinal canal) on days 1 and 8. Marqibo: The focus of the study design and statistical analysis is to determine whether Marqibo® can be substituted for standard vincristine and successfully administered to patients with relapsed ALL in three different treatment cohorts: (A) treatment with the UK ALL R3 regimen; (B) treatment with UK ALL R3 regimen without mitoxantrone, and (C) treatment with ALL maintenance therapy. Secondary objectives include estimating rates of serious toxicities and therapy delays in each of these cohorts.	Cohort C: Marqibo and Maintenance Regimen n=5 participants at risk * Marqibo®: given by intravenous (IV) infusion on day 1 * Dexamethasone orally twice daily on days 1-5 * Methotrexate: given orally on days 1 and 8 * Mercaptopurine: given orally daily on days 1-13 Marqibo: The focus of the study design and statistical analysis is to determine whether Marqibo® can be substituted for standard vincristine and successfully administered to patients with relapsed ALL in three different treatment cohorts: (A) treatment with the UK ALL R3 regimen; (B) treatment with UK ALL R3 regimen without mitoxantrone, and (C) treatment with ALL maintenance therapy. Secondary objectives include estimating rates of serious toxicities and therapy delays in each of these cohorts.
Blood and lymphatic system disorders Febrile neutropenia	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	20.0% 1/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Cardiac disorders Heart failure	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Gastrointestinal disorders Mucositis oral	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Infections and infestations Encephalitis infection	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Infections and infestations Infections and infestations - Other, specify	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	50.0% 1/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Infections and infestations Paronychia	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	20.0% 1/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Infections and infestations Sepsis	33.3% 4/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Infections and infestations Skin infection	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	20.0% 1/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Investigations Alanine aminotransferase increased	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	20.0% 1/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Investigations Lipase increased	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Metabolism and nutrition disorders Hypokalemia	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Nervous system disorders Hydrocephalus	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Vascular disorders Hematoma	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	20.0% 1/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Vascular disorders Vascular disorders - Other, specify	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks

Other adverse events

Other adverse events
Measure	Cohort A Dose Level 1: Marqibo and UK ALL R3 Backbone n=12 participants at risk * Marqibo®: given by intravenous (IV) infusion on days 1, 8, 15 and 22. * Dexamethasone orally twice daily on days 1-5 and 15-19. * Mitoxantrone: given by intravenous (IV) infusion on days 1 and 2. * PEG-asparaginase: given as an injection into the muscle on says 3 and 17. * Methotrexate IT: given intrathecally (used to treat the brain and spinal cord and is given using a needle inserted into the spinal canal) on days 1 and 8. Marqibo: The focus of the study design and statistical analysis is to determine whether Marqibo® can be substituted for standard vincristine and successfully administered to patients with relapsed ALL in three different treatment cohorts: (A) treatment with the UK ALL R3 regimen; (B) treatment with UK ALL R3 regimen without mitoxantrone, and (C) treatment with ALL maintenance therapy. Secondary objectives include estimating rates of serious toxicities and therapy delays in each of these cohorts.	Cohort A Dose Level 2: Marqibo and UK ALL R3 Backbone n=4 participants at risk * Marqibo®: given by intravenous (IV) infusion on days 1, 8, 15 and 22. * Dexamethasone orally twice daily on days 1-5 and 15-19. * Mitoxantrone: given by intravenous (IV) infusion on days 1 and 2. * PEG-asparaginase: given as an injection into the muscle on says 3 and 17. * Methotrexate IT: given intrathecally (used to treat the brain and spinal cord and is given using a needle inserted into the spinal canal) on days 1 and 8. Marqibo: The focus of the study design and statistical analysis is to determine whether Marqibo® can be substituted for standard vincristine and successfully administered to patients with relapsed ALL in three different treatment cohorts: (A) treatment with the UK ALL R3 regimen; (B) treatment with UK ALL R3 regimen without mitoxantrone, and (C) treatment with ALL maintenance therapy. Secondary objectives include estimating rates of serious toxicities and therapy delays in each of these cohorts.	Cohort B Dose Level 1: Marqibo and Lower Intensity UK ALL R3 Backbone n=6 participants at risk * Marqibo®: given by intravenous (IV) infusion on days 1, 8, 15 and 22. * Dexamethasone orally twice daily on days 1-5 and 15-19. * PEG-asparaginase: given as an injection into the muscle on days 3 and 17. * Methotrexate IT: given intrathecally (used to treat the brain and spinal cord and is given using a needle inserted into the spinal canal) on days 1 and 8. Marqibo: The focus of the study design and statistical analysis is to determine whether Marqibo® can be substituted for standard vincristine and successfully administered to patients with relapsed ALL in three different treatment cohorts: (A) treatment with the UK ALL R3 regimen; (B) treatment with UK ALL R3 regimen without mitoxantrone, and (C) treatment with ALL maintenance therapy. Secondary objectives include estimating rates of serious toxicities and therapy delays in each of these cohorts.	Cohort B Dose Level 2: Marqibo and Lower Intensity UK ALL R3 Backbone n=2 participants at risk * Marqibo®: given by intravenous (IV) infusion on days 1, 8, 15 and 22. * Dexamethasone orally twice daily on days 1-5 and 15-19. * PEG-asparaginase: given as an injection into the muscle on days 3 and 17. * Methotrexate IT: given intrathecally (used to treat the brain and spinal cord and is given using a needle inserted into the spinal canal) on days 1 and 8. Marqibo: The focus of the study design and statistical analysis is to determine whether Marqibo® can be substituted for standard vincristine and successfully administered to patients with relapsed ALL in three different treatment cohorts: (A) treatment with the UK ALL R3 regimen; (B) treatment with UK ALL R3 regimen without mitoxantrone, and (C) treatment with ALL maintenance therapy. Secondary objectives include estimating rates of serious toxicities and therapy delays in each of these cohorts.	Cohort C: Marqibo and Maintenance Regimen n=5 participants at risk * Marqibo®: given by intravenous (IV) infusion on day 1 * Dexamethasone orally twice daily on days 1-5 * Methotrexate: given orally on days 1 and 8 * Mercaptopurine: given orally daily on days 1-13 Marqibo: The focus of the study design and statistical analysis is to determine whether Marqibo® can be substituted for standard vincristine and successfully administered to patients with relapsed ALL in three different treatment cohorts: (A) treatment with the UK ALL R3 regimen; (B) treatment with UK ALL R3 regimen without mitoxantrone, and (C) treatment with ALL maintenance therapy. Secondary objectives include estimating rates of serious toxicities and therapy delays in each of these cohorts.
Blood and lymphatic system disorders Anemia	91.7% 11/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	100.0% 4/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	100.0% 6/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	100.0% 2/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	80.0% 4/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Blood and lymphatic system disorders Febrile neutropenia	33.3% 4/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	75.0% 3/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	33.3% 2/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Cardiac disorders Cardiac disorders - Other, specify	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	50.0% 1/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Cardiac disorders Chest pain - cardiac	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	20.0% 1/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Cardiac disorders Sinus bradycardia	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Cardiac disorders Sinus tachycardia	16.7% 2/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	33.3% 2/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	20.0% 1/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Eye disorders Blurred vision	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Eye disorders Dry eye	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Eye disorders Eye pain	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Eye disorders Photophobia	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Gastrointestinal disorders Abdominal distension	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Gastrointestinal disorders Abdominal pain	33.3% 4/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	33.3% 2/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	50.0% 1/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	20.0% 1/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Gastrointestinal disorders Ascites	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Gastrointestinal disorders Constipation	33.3% 4/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	50.0% 3/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	50.0% 1/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Gastrointestinal disorders Diarrhea	33.3% 4/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Gastrointestinal disorders Dyspepsia	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Gastrointestinal disorders Dysphagia	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Gastrointestinal disorders Enterocolitis	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Gastrointestinal disorders Mucositis oral	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Gastrointestinal disorders Nausea	66.7% 8/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	33.3% 2/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	50.0% 1/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	40.0% 2/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Gastrointestinal disorders Oral dysesthesia	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Gastrointestinal disorders Oral pain	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Gastrointestinal disorders Pancreatitis	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	50.0% 2/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	50.0% 1/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Gastrointestinal disorders Periodontal disease	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Gastrointestinal disorders Proctitis	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Gastrointestinal disorders Rectal pain	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Gastrointestinal disorders Stomach pain	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Gastrointestinal disorders Vomiting	41.7% 5/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	50.0% 3/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	50.0% 1/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
General disorders Edema face	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
General disorders Edema limbs	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
General disorders Fatigue	33.3% 4/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	33.3% 2/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	50.0% 1/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	20.0% 1/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
General disorders Fever	33.3% 4/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	33.3% 2/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	40.0% 2/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
General disorders General disorders and administration site conditions - Other, specify	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
General disorders Infusion related reaction	16.7% 2/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
General disorders Non-cardiac chest pain	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
General disorders Pain	16.7% 2/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Immune system disorders Allergic reaction	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	50.0% 1/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Immune system disorders Cytokine release syndrome	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Infections and infestations Encephalitis infection	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Infections and infestations Infections and infestations - Other, specify	25.0% 3/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	75.0% 3/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Infections and infestations Rash pustular	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Infections and infestations Sepsis	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Infections and infestations Sinusitis	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Infections and infestations Upper respiratory infection	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Injury, poisoning and procedural complications Fall	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Investigations Activated partial thromboplastin time prolonged	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	50.0% 3/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	50.0% 1/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	20.0% 1/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Investigations Alanine aminotransferase increased	75.0% 9/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	75.0% 3/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	66.7% 4/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	100.0% 2/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	80.0% 4/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Investigations Alkaline phosphatase increased	33.3% 4/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	50.0% 1/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	20.0% 1/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Investigations Aspartate aminotransferase increased	75.0% 9/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	75.0% 3/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	83.3% 5/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	100.0% 2/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	80.0% 4/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Investigations Blood bilirubin increased	16.7% 2/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	50.0% 3/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	100.0% 2/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	40.0% 2/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Investigations Blood lactate dehydrogenase increased	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Investigations Creatinine increased	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Investigations Ejection fraction decreased	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Investigations Electrocardiogram QT corrected interval prolonged	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Investigations Fibrinogen decreased	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Investigations GGT increased	25.0% 3/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	50.0% 2/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	40.0% 2/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Investigations INR increased	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	33.3% 2/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	50.0% 1/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Investigations Lipase increased	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	50.0% 2/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Investigations Lymphocyte count decreased	66.7% 8/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	75.0% 3/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	100.0% 6/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	100.0% 2/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	80.0% 4/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Investigations Neutrophil count decreased	75.0% 9/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	100.0% 4/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	100.0% 6/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	100.0% 2/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	60.0% 3/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Investigations Platelet count decreased	83.3% 10/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	100.0% 4/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	83.3% 5/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	100.0% 2/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	80.0% 4/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Investigations Serum amylase increased	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Investigations Weight loss	16.7% 2/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	33.3% 2/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	50.0% 1/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Investigations White blood cell decreased	75.0% 9/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	100.0% 4/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	100.0% 6/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	100.0% 2/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	100.0% 5/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Metabolism and nutrition disorders Hyperphosphatemia	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	20.0% 1/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Metabolism and nutrition disorders Anorexia	33.3% 4/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	66.7% 4/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	50.0% 1/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	20.0% 1/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Metabolism and nutrition disorders Dehydration	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	50.0% 1/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Metabolism and nutrition disorders Glucose intolerance	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Metabolism and nutrition disorders Hyperglycemia	50.0% 6/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	75.0% 3/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	66.7% 4/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	80.0% 4/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Metabolism and nutrition disorders Hyperkalemia	33.3% 4/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Metabolism and nutrition disorders Hypermagnesemia	41.7% 5/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	50.0% 2/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	33.3% 2/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	20.0% 1/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Metabolism and nutrition disorders Hypernatremia	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Metabolism and nutrition disorders Hypertriglyceridemia	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Metabolism and nutrition disorders Hyperuricemia	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	20.0% 1/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Metabolism and nutrition disorders Hypoalbuminemia	91.7% 11/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	100.0% 4/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	83.3% 5/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	100.0% 2/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	40.0% 2/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Metabolism and nutrition disorders Hypocalcemia	58.3% 7/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	83.3% 5/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	60.0% 3/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Metabolism and nutrition disorders Hypoglycemia	33.3% 4/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	33.3% 2/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Metabolism and nutrition disorders Hypokalemia	41.7% 5/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	100.0% 4/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	50.0% 3/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	50.0% 1/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	20.0% 1/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Metabolism and nutrition disorders Hypomagnesemia	41.7% 5/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	50.0% 2/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	66.7% 4/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	50.0% 1/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	20.0% 1/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Metabolism and nutrition disorders Hyponatremia	83.3% 10/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	100.0% 4/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	66.7% 4/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	50.0% 1/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	60.0% 3/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Metabolism and nutrition disorders Hypophosphatemia	50.0% 6/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	50.0% 2/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	66.7% 4/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	50.0% 1/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	20.0% 1/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Musculoskeletal and connective tissue disorders Back pain	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	33.3% 2/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	33.3% 2/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Musculoskeletal and connective tissue disorders Kyphosis	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Musculoskeletal and connective tissue disorders Myalgia	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	50.0% 1/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Musculoskeletal and connective tissue disorders Neck pain	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Musculoskeletal and connective tissue disorders Pain in extremity	25.0% 3/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	33.3% 2/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Nervous system disorders Dizziness	25.0% 3/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Nervous system disorders Headache	33.3% 4/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	75.0% 3/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	33.3% 2/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	50.0% 1/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	40.0% 2/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Nervous system disorders Nervous system disorders - Other, specify	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	50.0% 1/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Nervous system disorders Paresthesia	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Nervous system disorders Peripheral motor neuropathy	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Nervous system disorders Presyncope	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Nervous system disorders Somnolence	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Nervous system disorders Syncope	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Nervous system disorders Tremor	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	33.3% 2/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Psychiatric disorders Agitation	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Psychiatric disorders Anxiety	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	33.3% 2/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Psychiatric disorders Confusion	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Psychiatric disorders Delirium	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Psychiatric disorders Depression	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Psychiatric disorders Insomnia	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Renal and urinary disorders Acute kidney injury	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Renal and urinary disorders Hematuria	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Renal and urinary disorders Proteinuria	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Renal and urinary disorders Urinary frequency	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Reproductive system and breast disorders Reproductive system and breast disorders - Other, specify	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Reproductive system and breast disorders Vaginal discharge	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Reproductive system and breast disorders Vaginal dryness	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	20.0% 1/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	33.3% 2/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	20.0% 1/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	33.3% 2/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Respiratory, thoracic and mediastinal disorders Pleural effusion	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Respiratory, thoracic and mediastinal disorders Sore throat	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Skin and subcutaneous tissue disorders Alopecia	16.7% 2/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Skin and subcutaneous tissue disorders Dry skin	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Skin and subcutaneous tissue disorders Pruritus	8.3% 1/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Skin and subcutaneous tissue disorders Rash maculo-papular	25.0% 3/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	50.0% 1/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	0.00% 0/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	25.0% 1/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks
Vascular disorders Hypertension	25.0% 3/12 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	100.0% 4/4 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	16.7% 1/6 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/2 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks	0.00% 0/5 • Through 30 days after the last day of protocol therapy (cycle 1 only), approximately 9 weeks

Additional Information

Ellynore Florendo, CCRP

Therapeutic Advances in Childhood Leukemia and Lymphoma

Phone: 323-361-3022

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place