Trial Outcomes & Findings for AC220 for Children With Relapsed/Refractory ALL or AML (NCT NCT01411267)

Last Updated: 2022-04-04

Results Overview

The incidence of dose limiting toxicity (DLT) will be measured. The maximum tolerated dose will be the highest study dose at which 1 or fewer of six patients experience DLT during cycle 1 of therapy. Plasma inhibitor activity (PIA) will be measured Pre-treatment and on Days 7, 14, 21 and 28 of Course 1. For the MTD to be considered biologically active, we will require that 7 of 9 patients achieve PIA of \> 90% at 3 of 4 trough time points.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

24 participants

Primary outcome timeframe

4 weeks from therapy start

Results posted on

2022-04-04

Participant Flow

Participant milestones

Participant milestones
Measure	AML AC220 @ 25mg/m^2/Day (Dose Level 1) The starting dose is Dose Level 1 at 25 mg/m\^2/day. Dose escalation will proceed from level 1 to 2 to 3, and so on, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT cytarabine will be given to patients with AML on Day 0, dose assigned by age.	ALL AC220 @ 40mg/m^2/Day (Dose Level 2) Dose escalation will proceed from level 1 to level 2 for AC220 at 40mg/m\^2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Methotrexate will be given to patients with ALL on Day 0, dose assigned by age.	AML AC220 @ 40mg/m^2/Day (Dose Level 2) Dose escalation will proceed from level 1 to level 2 for AC220 at 40mg/m\^2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT cytarabine will be given to patients with AML on Day 0, dose assigned by age.	ALL AC220 @ 60mg/m^2/Day (Dose Level 3) Dose escalation will proceed from level 2 to 3 for AC220 at 60mg/m\^2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Methotrexate will be given to patients with ALL on Day 0, dose assigned by age. If toxicity at Dose Level 3 would allow further escalation, but demonstrated sufficient AC220 activity, no further dose escalation will be required.	AML AC220 @ 60mg/m^2/Day (Dose Level 3) Dose escalation will proceed from level 2 to 3 for AC220 at 60mg/m\^2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT cytarabine will be given to patients with AML on Day 0, dose assigned by age. If toxicity at Dose Level 3 would allow further escalation, but demonstrated sufficient AC220 activity, no further dose escalation will be required.
Overall Study STARTED	3	2	5	2	12
Overall Study COMPLETED	3	2	4	0	10
Overall Study NOT COMPLETED	0	0	1	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

AC220 for Children With Relapsed/Refractory ALL or AML

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ALL AC220 @ 25mg/m2/Day (Dose Level 1) The starting dose is Dose Level 1 at 25 mg/m\^2/day. Dose escalation will proceed from level 1 to 2 to 3, and so on, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Methotrexate will be given to patients with ALL on Day 0, dose assigned by age.	AML AC220 @ 25mg/m2/Day (Dose Level 1) n=3 Participants The starting dose is Dose Level 1 at 25 mg/m\^2/day. Dose escalation will proceed from level 1 to 2 to 3, and so on, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT cytarabine will be given to patients with AML on Day 0, dose assigned by age.	ALL AC220 @ 40mg/m2/Day (Dose Level 2) n=2 Participants Dose escalation will proceed from level 1 to level 2 for AC220 at 40mg/m\^2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Methotrexate will be given to patients with ALL on Day 0, dose assigned by age.	AML AC220 @ 40mg/m2/Day (Dose Level 2) n=5 Participants Dose escalation will proceed from level 1 to level 2 for AC220 at 40mg/m\^2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Cytarabine will be given to patients with AML on Day 0, dose assigned by age.	ALL AC220 @ 60mg/m2/Day (Dose Level 3) n=2 Participants Dose escalation will proceed from level 2 to 3 for AC220 at 60mg/m\^2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Methotrexate will be given to patients with ALL on Day 0, dose assigned by age. If toxicity at Dose Level 3 would allow further escalation, but demonstrated sufficient AC220 activity, no further dose escalation will be required.	AML AC220 @ 60mg/m2/Day (Dose Level 3) n=12 Participants Dose escalation will proceed from level 2 to 3 for AC220 at 60mg/m\^2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT cytarabine will be given to patients with AML on Day 0, dose assigned by age. If toxicity at Dose Level 3 would allow further escalation, but demonstrated sufficient AC220 activity, no further dose escalation will be required.	Total n=24 Participants Total of all reporting groups
Age, Continuous	—	13.1 years n=7 Participants	2.8 years n=5 Participants	13.1 years n=4 Participants	2.8 years n=21 Participants	13.1 years n=10 Participants	11.6 years n=115 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	7 Participants n=10 Participants	14 Participants n=115 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	5 Participants n=10 Participants	10 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=10 Participants	7 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	1 Participants n=21 Participants	8 Participants n=10 Participants	16 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	2 Participants n=115 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 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	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	8 Participants n=10 Participants	15 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	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	3 Participants n=10 Participants	3 Participants n=115 Participants
# Patients with Prior HSCT	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	5 Participants n=10 Participants	10 Participants n=115 Participants
FLT3/ITD+ (FLT3-internal tandem duplication mutation)	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	0 Participants n=21 Participants	5 Participants n=10 Participants	10 Participants n=115 Participants

PRIMARY outcome

Timeframe: 4 weeks from therapy start

Population: No patients with ALL were enrolled during Dose Level 1.

Outcome measures

Outcome measures
Measure	ALL AC220 @ 25mg/m^2/Day (Dose Level 1) The starting dose is Dose Level 1 at 25 mg/m2/day. Dose escalation will proceed from level 1 to 2 to 3, and so on, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Methotrexate will be given to patients with ALL on Day 0, dose assigned by age.	AML AC220 @ 25mg/m^2/Day (Dose Level 1) n=3 Participants The starting dose is Dose Level 1 at 25 mg/m2/day. Dose escalation will proceed from level 1 to 2 to 3, and so on, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT cytarabine will be given to patients with AML on Day 0, dose assigned by age.	ALL AC220 @ 40mg/m^2/Day (Dose Level 2) n=2 Participants Dose escalation will proceed from level 1 to level 2 for AC220 at 40mg/m2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Methotrexate will be given to patients with ALL on Day 0, dose assigned by age.	AML AC220 @ 40mg/m^2/Day (Dose Level 2) n=5 Participants Dose escalation will proceed from level 1 to level 2 for AC220 at 40mg/m2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT cytarabine will be given to patients with AML on Day 0, dose assigned by age.	ALL AC220 @ 60mg/m^2/Day (Dose Level 3) n=2 Participants Dose escalation will proceed from level 2 to 3 for AC220 at 60mg/m2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Methotrexate will be given to patients with ALL on Day 0, dose assigned by age. If toxicity at Dose Level 3 would allow further escalation, but demonstrated sufficient AC220 activity, no further dose escalation will be required.	AML AC220 @ 60mg/m^2/Day (Dose Level 3) n=12 Participants Dose escalation will proceed from level 2 to 3 for AC220 at 60mg/m2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT cytarabine will be given to patients with AML on Day 0, dose assigned by age. If toxicity at Dose Level 3 would allow further escalation, but demonstrated sufficient AC220 activity, no further dose escalation will be required.
The Dose of AC220 That is Safe and Biologically Active When Given in Sequential Combination With Ara-C/Etoposide patient completed therapy without DLT	0 Participants	3 Participants	1 Participants	4 Participants	0 Participants	8 Participants
The Dose of AC220 That is Safe and Biologically Active When Given in Sequential Combination With Ara-C/Etoposide patients experienced DLT	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
The Dose of AC220 That is Safe and Biologically Active When Given in Sequential Combination With Ara-C/Etoposide patients withdrew or not evaluable	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 10 weeks

Population: Five of 22 patients were not evaluable for response per protocol because they were removed from protocol therapy prior to disease assessment without meeting PD criteria

Possible outcomes are: Complete Remission (CR), Complete Remission without Platelet Recovery (CRp), complete response with incomplete hematologic recovery (CRi), Stable Disease, Progressive Disease, Induction Death, or Relapse

Outcome measures

Outcome measures
Measure	ALL AC220 @ 25mg/m^2/Day (Dose Level 1) n=3 Participants The starting dose is Dose Level 1 at 25 mg/m2/day. Dose escalation will proceed from level 1 to 2 to 3, and so on, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Methotrexate will be given to patients with ALL on Day 0, dose assigned by age.	AML AC220 @ 25mg/m^2/Day (Dose Level 1) n=7 Participants The starting dose is Dose Level 1 at 25 mg/m2/day. Dose escalation will proceed from level 1 to 2 to 3, and so on, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT cytarabine will be given to patients with AML on Day 0, dose assigned by age.	ALL AC220 @ 40mg/m^2/Day (Dose Level 2) n=7 Participants Dose escalation will proceed from level 1 to level 2 for AC220 at 40mg/m2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Methotrexate will be given to patients with ALL on Day 0, dose assigned by age.	AML AC220 @ 40mg/m^2/Day (Dose Level 2) Dose escalation will proceed from level 1 to level 2 for AC220 at 40mg/m2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT cytarabine will be given to patients with AML on Day 0, dose assigned by age.	ALL AC220 @ 60mg/m^2/Day (Dose Level 3) Dose escalation will proceed from level 2 to 3 for AC220 at 60mg/m2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Methotrexate will be given to patients with ALL on Day 0, dose assigned by age. If toxicity at Dose Level 3 would allow further escalation, but demonstrated sufficient AC220 activity, no further dose escalation will be required.	AML AC220 @ 60mg/m^2/Day (Dose Level 3) Dose escalation will proceed from level 2 to 3 for AC220 at 60mg/m2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT cytarabine will be given to patients with AML on Day 0, dose assigned by age. If toxicity at Dose Level 3 would allow further escalation, but demonstrated sufficient AC220 activity, no further dose escalation will be required.
Disease Response CR	0 Participants	1 Participants	1 Participants	—	—	—
Disease Response CRi	0 Participants	0 Participants	1 Participants	—	—	—
Disease Response CRp	0 Participants	0 Participants	1 Participants	—	—	—
Disease Response SD	1 Participants	5 Participants	4 Participants	—	—	—
Disease Response PD	2 Participants	1 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: 4 weeks from therapy start

Population: Nineteen of 22 patients had PIA assessment.

PIA samples will be collected pre-treatment and on Days 7, 14, 21 and 28 of Course 1.

Outcome measures

Outcome measures
Measure	ALL AC220 @ 25mg/m^2/Day (Dose Level 1) n=19 Participants The starting dose is Dose Level 1 at 25 mg/m2/day. Dose escalation will proceed from level 1 to 2 to 3, and so on, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Methotrexate will be given to patients with ALL on Day 0, dose assigned by age.	AML AC220 @ 25mg/m^2/Day (Dose Level 1) The starting dose is Dose Level 1 at 25 mg/m2/day. Dose escalation will proceed from level 1 to 2 to 3, and so on, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT cytarabine will be given to patients with AML on Day 0, dose assigned by age.	ALL AC220 @ 40mg/m^2/Day (Dose Level 2) Dose escalation will proceed from level 1 to level 2 for AC220 at 40mg/m2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Methotrexate will be given to patients with ALL on Day 0, dose assigned by age.	AML AC220 @ 40mg/m^2/Day (Dose Level 2) Dose escalation will proceed from level 1 to level 2 for AC220 at 40mg/m2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT cytarabine will be given to patients with AML on Day 0, dose assigned by age.	ALL AC220 @ 60mg/m^2/Day (Dose Level 3) Dose escalation will proceed from level 2 to 3 for AC220 at 60mg/m2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Methotrexate will be given to patients with ALL on Day 0, dose assigned by age. If toxicity at Dose Level 3 would allow further escalation, but demonstrated sufficient AC220 activity, no further dose escalation will be required.	AML AC220 @ 60mg/m^2/Day (Dose Level 3) Dose escalation will proceed from level 2 to 3 for AC220 at 60mg/m2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT cytarabine will be given to patients with AML on Day 0, dose assigned by age. If toxicity at Dose Level 3 would allow further escalation, but demonstrated sufficient AC220 activity, no further dose escalation will be required.
Count of Participants According to Inhibition of FLT3 Phosphorylation 100% inhibition	9 Participants	—	—	—	—	—
Count of Participants According to Inhibition of FLT3 Phosphorylation 97-99% inhibition	9 Participants	—	—	—	—	—
Count of Participants According to Inhibition of FLT3 Phosphorylation 94% inhibition	1 Participants	—	—	—	—	—

Adverse Events

ALL Dose Level 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AML Dose Level 1

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

ALL Dose Level 2

Serious events: 1 serious events

Other events: 2 other events

Deaths: 2 deaths

AML Dose Level 2

Serious events: 3 serious events

Other events: 5 other events

Deaths: 3 deaths

ALL Dose Level 3

Serious events: 0 serious events

Other events: 2 other events

Deaths: 1 deaths

AML Dose Level 3

Serious events: 4 serious events

Other events: 10 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	ALL Dose Level 1 The starting dose is Dose Level 1 at 25 mg/m\^2/day. Dose escalation will proceed from level 1 to 2 to 3, and so on, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Methotrexate will be given to patients with ALL on Day 0, dose assigned by age.	AML Dose Level 1 n=3 participants at risk The starting dose is Dose Level 1 at 25 mg/m\^2/day. Dose escalation will proceed from level 1 to 2 to 3, and so on, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT cytarabine will be given to patients with AML on Day 0, dose assigned by age.	ALL Dose Level 2 n=2 participants at risk Dose escalation will proceed from level 1 to level 2 for AC220 at 40mg/m\^2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Methotrexate will be given to patients with ALL on Day 0, dose assigned by age.	AML Dose Level 2 n=5 participants at risk Dose escalation will proceed from level 1 to level 2 for AC220 at 40mg/m\^2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Cytarabine will be given to patients with AML on Day 0, dose assigned by age.	ALL Dose Level 3 n=2 participants at risk Dose escalation will proceed from level 2 to 3 for AC220 at 60mg/m\^2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Methotrexate will be given to patients with ALL on Day 0, dose assigned by age. If toxicity at Dose Level 3 would allow further escalation, but demonstrated sufficient AC220 activity, no further dose escalation will be required.	AML Dose Level 3 n=10 participants at risk Dose escalation will proceed from level 2 to 3 for AC220 at 60mg/m\^2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Cytarabine will be given to patients with AML on Day 0, dose assigned by age. If toxicity at Dose Level 3 would allow further escalation, but demonstrated sufficient AC220 activity, no further dose escalation will be required.
Immune system disorders Anaphylaxis	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 1/5 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Investigations Blood bilirubin increased	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 1/5 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	10.0% 1/10 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
General disorders Chest wall pain	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Blood and lymphatic system disorders Febrile neutropenia	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	10.0% 1/10 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
General disorders Fever	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 1/5 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hypokalemia	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	10.0% 1/10 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Vascular disorders Hypotension	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 1/5 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Infections and infestations Infections and infestations - Other, Not Specified	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 2/10 • Number of events 2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Investigations Lipase increased	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 1/5 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Infections and infestations Lung infection	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	33.3% 1/3 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Gastrointestinal disorders Pancreatitis	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	10.0% 1/10 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Respiratory, thoracic and mediastinal disorders Pleural effusion	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 1/5 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 1/5 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Respiratory, thoracic and mediastinal disorders Respiratory failure	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 1/5 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	10.0% 1/10 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Infections and infestations Sepsis	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 1/5 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Skin and subcutaneous tissue disorders Skin & subcutaneous tissue disorder-Other	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Skin and subcutaneous tissue disorders Skin infection	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	40.0% 2/5 • Number of events 2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Blood and lymphatic system disorders Infection and Infestations - Rhinovirus	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	33.3% 1/3 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Blood and lymphatic system disorders Infections and Infestations - Staphylococcus epidermidis	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	33.3% 1/3 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	50.0% 1/2 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Blood and lymphatic system disorders Infections and Infestations - streptococcal pharyngitis	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	33.3% 1/3 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Blood and lymphatic system disorders Infections and Infestations - Pseudomonas	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 1/5 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.

Other adverse events

Other adverse events
Measure	ALL Dose Level 1 The starting dose is Dose Level 1 at 25 mg/m\^2/day. Dose escalation will proceed from level 1 to 2 to 3, and so on, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Methotrexate will be given to patients with ALL on Day 0, dose assigned by age.	AML Dose Level 1 n=3 participants at risk The starting dose is Dose Level 1 at 25 mg/m\^2/day. Dose escalation will proceed from level 1 to 2 to 3, and so on, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT cytarabine will be given to patients with AML on Day 0, dose assigned by age.	ALL Dose Level 2 n=2 participants at risk Dose escalation will proceed from level 1 to level 2 for AC220 at 40mg/m\^2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Methotrexate will be given to patients with ALL on Day 0, dose assigned by age.	AML Dose Level 2 n=5 participants at risk Dose escalation will proceed from level 1 to level 2 for AC220 at 40mg/m\^2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Cytarabine will be given to patients with AML on Day 0, dose assigned by age.	ALL Dose Level 3 n=2 participants at risk Dose escalation will proceed from level 2 to 3 for AC220 at 60mg/m\^2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Methotrexate will be given to patients with ALL on Day 0, dose assigned by age. If toxicity at Dose Level 3 would allow further escalation, but demonstrated sufficient AC220 activity, no further dose escalation will be required.	AML Dose Level 3 n=10 participants at risk Dose escalation will proceed from level 2 to 3 for AC220 at 60mg/m\^2/day, assuming the maximum tolerated dose is not exceeded. Patients will received etoposide and cytarabine on Days 1-5, and AC220 on Day 7 through 28. IT Cytarabine will be given to patients with AML on Day 0, dose assigned by age. If toxicity at Dose Level 3 would allow further escalation, but demonstrated sufficient AC220 activity, no further dose escalation will be required.
Blood and lymphatic system disorders Lymphocyte count decreased	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	66.7% 2/3 • Number of events 3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	50.0% 1/2 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	60.0% 3/5 • Number of events 3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	50.0% 5/10 • Number of events 5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Investigations Activated partial thromboplastin time prolonged	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	10.0% 1/10 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Investigations Alanine aminotransferase increased	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	66.7% 2/3 • Number of events 2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 1/5 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Investigations Alkaline phosphatase increased	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	10.0% 1/10 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Blood and lymphatic system disorders Anemia	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	100.0% 3/3 • Number of events 3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	50.0% 1/2 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	80.0% 4/5 • Number of events 5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	50.0% 1/2 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	60.0% 6/10 • Number of events 6 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Metabolism and nutrition disorders Anorexia	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	40.0% 2/5 • Number of events 2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 2/10 • Number of events 2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Musculoskeletal and connective tissue disorders Arthralgia	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	50.0% 1/2 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Investigations Aspartate aminotransferase increased	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	33.3% 1/3 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 1/5 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 2/10 • Number of events 2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Investigations Blood bilirubin increased	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 1/5 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	10.0% 1/10 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Infections and infestations Catheter related infection	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 1/5 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	10.0% 1/10 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Gastrointestinal disorders Constipation	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 2/10 • Number of events 2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Investigations Creatinine increased	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	50.0% 1/2 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Gastrointestinal disorders Diarrhea	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 1/5 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Respiratory, thoracic and mediastinal disorders Dyspnea	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 1/5 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Blood and lymphatic system disorders Febrile neutropenia	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	50.0% 1/2 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	60.0% 3/5 • Number of events 3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	50.0% 1/2 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	60.0% 6/10 • Number of events 6 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
General disorders Fever	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 1/5 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	30.0% 3/10 • Number of events 3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hyperglycemia	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	33.3% 1/3 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	40.0% 2/5 • Number of events 2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	30.0% 3/10 • Number of events 3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hypermagnesemia	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	10.0% 1/10 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Vascular disorders Hypertension	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	50.0% 1/2 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hypoalbuminemia	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 1/5 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hypocalcemia	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 1/5 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	50.0% 1/2 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hypokalemia	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	50.0% 1/2 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	40.0% 2/5 • Number of events 2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	100.0% 2/2 • Number of events 2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	90.0% 9/10 • Number of events 9 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hypomagnesemia	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	80.0% 8/10 • Number of events 8 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hyponatremia	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 1/5 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Metabolism and nutrition disorders Hypophosphatemia	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 1/5 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	50.0% 1/2 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	10.0% 1/10 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Vascular disorders Hypotension	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 2/10 • Number of events 2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Respiratory, thoracic and mediastinal disorders Hypoxia	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 1/5 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	40.0% 4/10 • Number of events 4 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Infections and infestations Infections and infestations - Other - Not otherwise Specified	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	10.0% 1/10 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Infections and infestations Lung infection	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	10.0% 1/10 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Gastrointestinal disorders Mucositis oral	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	40.0% 2/5 • Number of events 2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Gastrointestinal disorders Nausea	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	10.0% 1/10 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Blood and lymphatic system disorders Neutrophil count decreased	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	33.3% 1/3 • Number of events 2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	50.0% 1/2 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	40.0% 2/5 • Number of events 2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	50.0% 1/2 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	60.0% 6/10 • Number of events 7 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
General disorders Pain	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 1/5 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 2/10 • Number of events 2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Musculoskeletal and connective tissue disorders Pain in extremity	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	50.0% 1/2 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	10.0% 1/10 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Blood and lymphatic system disorders Platelet count decreased	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	66.7% 2/3 • Number of events 2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	100.0% 2/2 • Number of events 2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	60.0% 3/5 • Number of events 4 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	50.0% 1/2 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	70.0% 7/10 • Number of events 8 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Skin and subcutaneous tissue disorders Rash maculo-papular	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 2/10 • Number of events 2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Gastrointestinal disorders Rectal pain	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 2/10 • Number of events 2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Skin and subcutaneous tissue disorders Skin & subcutaneous tissue disorder-Other - Not otherwise specified	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	33.3% 1/3 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 1/5 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Respiratory, thoracic and mediastinal disorders Sore throat	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 1/5 • Number of events 2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Gastrointestinal disorders Vomiting	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 1/5 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Investigations White blood cell decreased	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	100.0% 3/3 • Number of events 4 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	50.0% 1/2 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	100.0% 5/5 • Number of events 5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	50.0% 1/2 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	60.0% 6/10 • Number of events 6 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Infections and infestations Device related infection	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	10.0% 1/10 • Number of events 2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Gastrointestinal disorders Pancreatitis	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	10.0% 1/10 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Infections and infestations Perirectal Abcess	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	10.0% 1/10 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Skin and subcutaneous tissue disorders Pilonidal cyst	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	10.0% 1/10 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Infections and infestations Blood Culture infection	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	66.7% 2/3 • Number of events 2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	50.0% 1/2 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	10.0% 1/10 • Number of events 2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
General disorders Headache	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	40.0% 2/5 • Number of events 2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
General disorders Tachypnea	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	50.0% 1/2 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 1/5 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	50.0% 1/2 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	10.0% 1/10 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
General disorders Rhinorrhea	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	50.0% 1/2 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	50.0% 1/2 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Skin and subcutaneous tissue disorders Erythmea	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	50.0% 1/2 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	10.0% 1/10 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
General disorders Irritation to central line site	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	50.0% 1/2 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	50.0% 1/2 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Skin and subcutaneous tissue disorders Left neck peeling	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 1/5 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Skin and subcutaneous tissue disorders Drainage & reddened skin at Hickman CL site	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	10.0% 1/10 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Skin and subcutaneous tissue disorders Ara-C Skin Rash	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	50.0% 1/2 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Skin and subcutaneous tissue disorders Skin Nodules - Not otherwise specified	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	50.0% 1/2 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Blood and lymphatic system disorders Strep Veridans Bacteremia	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/3 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	20.0% 1/5 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.
Skin and subcutaneous tissue disorders Rash on Chest and Upper Arms	— 0/0 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	33.3% 1/3 • Number of events 1 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/5 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/2 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse events and suspected adverse reactions will be collected and reported on the electronic CRFs beginning with the first dose of study therapy until 30 days following the last dose of study therapy (a period of approximately 90 days). The definitions of AE and SAE do not differ from the clinicaltrials.gov definitions.

Additional Information

Peggy Romano, BA, CCRP

Therapeutic Advances in Childhood Leukemia & Lymphoma (TACL) / Children's Hospital Los Angeles

Phone: 323-361-5505

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60