Trial Outcomes & Findings for Safety & Efficacy of True Human Antibody, 514G3, in Staphylococcus Aureus Bacteremia Hospitalized Subjects. (NCT NCT02357966)

Last Updated: 2026-02-09

Results Overview

Dose limiting Toxicity are defined as any Grade 3 or greater AE which is probably or definitely related to 514G3 occurring during the FU period after dosing. This measure determines and assesses the maximum tolerated dose (MTD) through participants who experienced DLT at different dose levels.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

52 participants

Primary outcome timeframe

Pre-dose at Day 0 through Day 14. After day 14, samples are collected every other day including discharge, up to 30 days maximum

Results posted on

2026-02-09

Participant Flow

Participant milestones

Participant milestones
Measure	Phase II: 514G3 (40 mg/kg) Plus Standard IV Antibiotic Therapy Participants received a single dose of 5143G (dose 40 mg/kg) plus standard IV antibiotic treatment	Phase II: Placebo Plus Standard IV Antibiotic Therapy Participants received a single dose of placebo plus standard IV antibiotic therapy.	514G3 (2 mg/kg) Plus Standard IV Antibiotic Therapy Participants received a single dose of 5143G (dose 2 mg/kg) plus standard IV antibiotic therapy.	514G3 (10 mg/kg) Plus Standard IV Antibiotic Therapy Participants received a single dose of 5143G (dose 10 mg/kg) plus standard IV antibiotic therapy.	514G3 (40 mg/kg) Plus Standard IV Antibiotic Therapy Participants received a single dose of 5143G (dose 40 mg/kg) plus standard IV antibiotic therapy.	Placebo Plus Standard IV Antibiotic Therapy Participants in this group received a single dose of placebo plus standard IV antibiotic therapy. Placebo is a sterile isotonic formulation buffered at pH 6.2 - 6.5
Overall Study STARTED	24	12	3	3	6	4
Overall Study COMPLETED	21	12	2	3	5	4
Overall Study NOT COMPLETED	3	0	1	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase II: 514G3 (40 mg/kg) Plus Standard IV Antibiotic Therapy Participants received a single dose of 5143G (dose 40 mg/kg) plus standard IV antibiotic treatment	Phase II: Placebo Plus Standard IV Antibiotic Therapy Participants received a single dose of placebo plus standard IV antibiotic therapy.	514G3 (2 mg/kg) Plus Standard IV Antibiotic Therapy Participants received a single dose of 5143G (dose 2 mg/kg) plus standard IV antibiotic therapy.	514G3 (10 mg/kg) Plus Standard IV Antibiotic Therapy Participants received a single dose of 5143G (dose 10 mg/kg) plus standard IV antibiotic therapy.	514G3 (40 mg/kg) Plus Standard IV Antibiotic Therapy Participants received a single dose of 5143G (dose 40 mg/kg) plus standard IV antibiotic therapy.	Placebo Plus Standard IV Antibiotic Therapy Participants in this group received a single dose of placebo plus standard IV antibiotic therapy. Placebo is a sterile isotonic formulation buffered at pH 6.2 - 6.5
Overall Study Death	2	0	0	0	1	0
Overall Study Physician Decision	1	0	1	0	0	0

Baseline Characteristics

Safety & Efficacy of True Human Antibody, 514G3, in Staphylococcus Aureus Bacteremia Hospitalized Subjects.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase II: 514G3 (40 mg/kg) Plus Standard IV Antibiotic Treatment n=24 Participants The participant received a single dose of 514G3 (40 mg/kg) plus standard IV antibiotic therapy	Phase II: Placebo Plus Standard IV Antibiotic Treatment n=12 Participants The participant received a single dose of placebo plus standard IV antibiotic therapy.	Total n=52 Participants Total of all reporting groups	514G3 (2 mg/kg) Plus Standard IV Antibiotic Treatment n=3 Participants The participant received 514G3 (2 mg/kg) plus standard IV antibiotic treatment	514G3 (10 mg/kg) Plus Standard IV Antibiotic Treatment n=3 Participants The participant received 514G3 (10 mg/kg) plus standard IV antibiotic treatment	514G3 (40 mg/kg) Plus Standard IV Antibiotic Treatment n=6 Participants The participant received 514G3 (40 mg/kg) plus standard IV antibiotic treatment	Placebo Plus Standard IV Antibiotic Treatment n=4 Participants The participant received placebo (sterile isotonic formulation buffered at pH 6.2 - 6.5) plus standard IV antibiotic treatment
Age, Categorical <=18 years	0 Participants n=96 Participants	0 Participants n=2 Participants	0 Participants n=6 Participants	0 Participants n=362 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	0 Participants n=17 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=96 Participants	10 Participants n=2 Participants	39 Participants n=6 Participants	2 Participants n=362 Participants	2 Participants n=3 Participants	5 Participants n=7 Participants	3 Participants n=17 Participants
Age, Categorical >=65 years	7 Participants n=96 Participants	2 Participants n=2 Participants	13 Participants n=6 Participants	1 Participants n=362 Participants	1 Participants n=3 Participants	1 Participants n=7 Participants	1 Participants n=17 Participants
Sex: Female, Male Female	8 Participants n=96 Participants	3 Participants n=2 Participants	17 Participants n=6 Participants	2 Participants n=362 Participants	1 Participants n=3 Participants	2 Participants n=7 Participants	1 Participants n=17 Participants
Sex: Female, Male Male	16 Participants n=96 Participants	9 Participants n=2 Participants	35 Participants n=6 Participants	1 Participants n=362 Participants	2 Participants n=3 Participants	4 Participants n=7 Participants	3 Participants n=17 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=96 Participants	1 Participants n=2 Participants	2 Participants n=6 Participants	0 Participants n=362 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	0 Participants n=17 Participants
Race (NIH/OMB) Asian	4 Participants n=96 Participants	0 Participants n=2 Participants	4 Participants n=6 Participants	0 Participants n=362 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	0 Participants n=17 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=96 Participants	0 Participants n=2 Participants	0 Participants n=6 Participants	0 Participants n=362 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	0 Participants n=17 Participants
Race (NIH/OMB) Black or African American	5 Participants n=96 Participants	2 Participants n=2 Participants	13 Participants n=6 Participants	1 Participants n=362 Participants	1 Participants n=3 Participants	2 Participants n=7 Participants	2 Participants n=17 Participants
Race (NIH/OMB) White	14 Participants n=96 Participants	9 Participants n=2 Participants	33 Participants n=6 Participants	2 Participants n=362 Participants	2 Participants n=3 Participants	4 Participants n=7 Participants	2 Participants n=17 Participants
Race (NIH/OMB) More than one race	0 Participants n=96 Participants	0 Participants n=2 Participants	0 Participants n=6 Participants	0 Participants n=362 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	0 Participants n=17 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=96 Participants	0 Participants n=2 Participants	0 Participants n=6 Participants	0 Participants n=362 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants	0 Participants n=17 Participants

PRIMARY outcome

Timeframe: Pre-dose at Day 0 through Day 14. After day 14, samples are collected every other day including discharge, up to 30 days maximum

Population: Participants in Phase 1 who received a single IV dose of 514G3 (2mg/kg, 10mg/kg, and 40mg/kg) is a sequential manner

Outcome measures

Outcome measures
Measure	514G3 (10 mg/kg) Plus Standard IV Antibiotic Therapy n=3 Participants The participants received a single dose of 10 mg/kg study drug (5143G) intravenously (IV) plus standard IV antibiotic therapy.	514G3 (40 mg/kg) Plus Standard IV Antibiotic Therapy n=6 Participants The participants received a single dose of 40 mg/kg study drug (5143G) plus standard IV antibiotic therapy.	Placebo Plus Standard IV Antibiotic Therapy n=4 Participants A single dose of placebo plus standard IV antibiotic therapy	Phase II: 40 mg/kg Study Drug (514G3) Plus Standard IV Antibiotic Treatment The participants received single dose of 40 mg/kg study drug (5143G) plus standard IV therapy.	Phase II: Placebo Plus Standard IV Antibiotic Therapy The participants received single dose of placebo plus standard IV antibiotic therapy.	514G3 (2 mg/kg) Plus Standard IV Antibiotic Therapy n=3 Participants The participants received a single dose of 2 mg/kg study drug (5143G) intravenously (IV) plus standard IV antibiotic therapy.
Number of Participants Who Experienced Dose-limiting Toxicities	0 participants	0 participants	0 participants	—	—	0 participants

PRIMARY outcome

Timeframe: Adverse events occurring between day 0 and day 30 or hospital discharge whichever is shorter

Population: This measure assesses all adverse events from all randomized participants who received at least 1 dose of study drug according to the assigned treatment.

A summary of SAEs and other non-serious AEs, regardless of causality

Outcome measures

Outcome measures
Measure	514G3 (10 mg/kg) Plus Standard IV Antibiotic Therapy n=3 Participants The participants received a single dose of 10 mg/kg study drug (5143G) intravenously (IV) plus standard IV antibiotic therapy.	514G3 (40 mg/kg) Plus Standard IV Antibiotic Therapy n=6 Participants The participants received a single dose of 40 mg/kg study drug (5143G) plus standard IV antibiotic therapy.	Placebo Plus Standard IV Antibiotic Therapy n=4 Participants A single dose of placebo plus standard IV antibiotic therapy	Phase II: 40 mg/kg Study Drug (514G3) Plus Standard IV Antibiotic Treatment n=24 Participants The participants received single dose of 40 mg/kg study drug (5143G) plus standard IV therapy.	Phase II: Placebo Plus Standard IV Antibiotic Therapy n=12 Participants The participants received single dose of placebo plus standard IV antibiotic therapy.	514G3 (2 mg/kg) Plus Standard IV Antibiotic Therapy n=3 Participants The participants received a single dose of 2 mg/kg study drug (5143G) intravenously (IV) plus standard IV antibiotic therapy.
Number of Participants Who Experienced the Adverse Events Serious adverse events	1 participants	1 participants	2 participants	5 participants	5 participants	1 participants
Number of Participants Who Experienced the Adverse Events Non-serious adverse events	3 participants	6 participants	4 participants	23 participants	9 participants	2 participants

SECONDARY outcome

Timeframe: Pre-dose at Day 0 through Day 14. After day 14, samples are collected every other day including discharge, up to 30 days maximum

Population: All participants who had ≥1 positive blood cultures for staphylococcus Aureus within 2 days of randomization

The time to sterile culture is the interval in days from the first dose of study drug until 2 consecutive days of negative blood cultures has occurred. The difference in this interval will be compared between patients randomized to placebo and those who received the highest dose of 514G3.

Outcome measures

Outcome measures
Measure	514G3 (10 mg/kg) Plus Standard IV Antibiotic Therapy n=3 Participants The participants received a single dose of 10 mg/kg study drug (5143G) intravenously (IV) plus standard IV antibiotic therapy.	514G3 (40 mg/kg) Plus Standard IV Antibiotic Therapy n=6 Participants The participants received a single dose of 40 mg/kg study drug (5143G) plus standard IV antibiotic therapy.	Placebo Plus Standard IV Antibiotic Therapy n=4 Participants A single dose of placebo plus standard IV antibiotic therapy	Phase II: 40 mg/kg Study Drug (514G3) Plus Standard IV Antibiotic Treatment n=24 Participants The participants received single dose of 40 mg/kg study drug (5143G) plus standard IV therapy.	Phase II: Placebo Plus Standard IV Antibiotic Therapy n=12 Participants The participants received single dose of placebo plus standard IV antibiotic therapy.	514G3 (2 mg/kg) Plus Standard IV Antibiotic Therapy n=3 Participants The participants received a single dose of 2 mg/kg study drug (5143G) intravenously (IV) plus standard IV antibiotic therapy.
Time to Clearance of Bacteremia (Time to Sterile Culture From Date of Randomization)	3.67 Days Standard Deviation 1.53	2.0 Days Standard Deviation 0.89	3.5 Days Standard Deviation 1.91	2.54 Days Standard Deviation 2.28	2.33 Days Standard Deviation 1.50	1.67 Days Standard Deviation 0.58

SECONDARY outcome

Timeframe: Pre-dose at Day 0 through Day 14. After day 14, samples are collected every other day including discharge, up to 30 days maximum

Population: The PK-evaluable population included participants in the treatment arm who received 514G3 who had no major protocol violations and had documented adherence to the dosing and PK regimens. Data was not collected from subjects assigned to the placebo arm.

Blood samples were collected from participants who received study drug 514G3 for the determination of plasma concentration (Cmax).

Outcome measures

Outcome measures
Measure	514G3 (10 mg/kg) Plus Standard IV Antibiotic Therapy n=3 Participants The participants received a single dose of 10 mg/kg study drug (5143G) intravenously (IV) plus standard IV antibiotic therapy.	514G3 (40 mg/kg) Plus Standard IV Antibiotic Therapy n=6 Participants The participants received a single dose of 40 mg/kg study drug (5143G) plus standard IV antibiotic therapy.	Placebo Plus Standard IV Antibiotic Therapy n=24 Participants A single dose of placebo plus standard IV antibiotic therapy	Phase II: 40 mg/kg Study Drug (514G3) Plus Standard IV Antibiotic Treatment The participants received single dose of 40 mg/kg study drug (5143G) plus standard IV therapy.	Phase II: Placebo Plus Standard IV Antibiotic Therapy The participants received single dose of placebo plus standard IV antibiotic therapy.	514G3 (2 mg/kg) Plus Standard IV Antibiotic Therapy n=3 Participants The participants received a single dose of 2 mg/kg study drug (5143G) intravenously (IV) plus standard IV antibiotic therapy.
Steady State Maximum Concentration of 514G3	198.0 microgram/millilitre Standard Deviation 88.9	684.7 microgram/millilitre Standard Deviation 143.1	740.0 microgram/millilitre Standard Deviation 202.4	—	—	37.5 microgram/millilitre Standard Deviation 22.4

SECONDARY outcome

Timeframe: Pre-dose at Day 0 through Day 14. After day 14, samples are collected every other day including discharge, up to 30 days maximum

Population: The analysis population for this study will include all eligible subjects who have been randomized and received at least one dose of the study drug or placebo in both phases of the protocol.

This outcome measure assesses the impact of the treatment on the time that participants spend in the hospital. The duration of hospitalization is expressed as the average number of days hospitalized for all participants in their respective cohorts.

Outcome measures

Outcome measures
Measure	514G3 (10 mg/kg) Plus Standard IV Antibiotic Therapy n=3 Participants The participants received a single dose of 10 mg/kg study drug (5143G) intravenously (IV) plus standard IV antibiotic therapy.	514G3 (40 mg/kg) Plus Standard IV Antibiotic Therapy n=6 Participants The participants received a single dose of 40 mg/kg study drug (5143G) plus standard IV antibiotic therapy.	Placebo Plus Standard IV Antibiotic Therapy n=4 Participants A single dose of placebo plus standard IV antibiotic therapy	Phase II: 40 mg/kg Study Drug (514G3) Plus Standard IV Antibiotic Treatment n=24 Participants The participants received single dose of 40 mg/kg study drug (5143G) plus standard IV therapy.	Phase II: Placebo Plus Standard IV Antibiotic Therapy n=12 Participants The participants received single dose of placebo plus standard IV antibiotic therapy.	514G3 (2 mg/kg) Plus Standard IV Antibiotic Therapy n=3 Participants The participants received a single dose of 2 mg/kg study drug (5143G) intravenously (IV) plus standard IV antibiotic therapy.
Length of Hospitalization (Duration of Hospitalization Stay After Randomization)	11.33 Days Standard Deviation 3.06	11.67 Days Standard Deviation 4.18	20 Days Standard Deviation 6.98	13.71 Days Standard Deviation 9.07	17 Days Standard Deviation 11.09	23.67 Days Standard Deviation 21.36

SECONDARY outcome

Timeframe: 14 days

Population: Safety population is all randomized participants who received at least one dose of the study treatment and provided valid Opsonophagocytosis assay (OPA) results'. Intent-to-treat (ITT) population is same as the safety population.

Serum samples from patients will be assessed with an in-vitro Opsonophagocytosis assay which measures the ability of the serum to mediate uptake of staphylococcus aureus by white blood cells. Differences in the levels of activity will be compared between treatment and placebo. This outcome measure assesses the dose-dependent functional antibody response to 514G3, providing insights into its potential efficacy across different dosage levels compared to placebo. Higher titers in the drug-treated groups indicate better opsonophagocytic activity and thus better efficacy of the drug. Opsonophagocytosis activity (OPA) score quantifies the functional antibody response to the investigational drug 514G3. For Phase II, this score is determined using an Opsonophagocytosis assay and is calculated as follows: Relative Opsonophagocytosis activity = %Phagocytosis 30 minutes after treatment adjusted by baseline / %Phagocytosis of 500 ug/mL spike standard.

Outcome measures

Outcome measures
Measure	514G3 (10 mg/kg) Plus Standard IV Antibiotic Therapy n=12 Participants The participants received a single dose of 10 mg/kg study drug (5143G) intravenously (IV) plus standard IV antibiotic therapy.	514G3 (40 mg/kg) Plus Standard IV Antibiotic Therapy The participants received a single dose of 40 mg/kg study drug (5143G) plus standard IV antibiotic therapy.	Placebo Plus Standard IV Antibiotic Therapy A single dose of placebo plus standard IV antibiotic therapy	Phase II: 40 mg/kg Study Drug (514G3) Plus Standard IV Antibiotic Treatment The participants received single dose of 40 mg/kg study drug (5143G) plus standard IV therapy.	Phase II: Placebo Plus Standard IV Antibiotic Therapy The participants received single dose of placebo plus standard IV antibiotic therapy.	514G3 (2 mg/kg) Plus Standard IV Antibiotic Therapy n=24 Participants The participants received a single dose of 2 mg/kg study drug (5143G) intravenously (IV) plus standard IV antibiotic therapy.
Difference in Opsonophagocytosis Activity Between Arms (Pharmacodynamics)	1.1 percentage of phagocytosis activity Standard Deviation 2.5	—	—	—	—	129.7 percentage of phagocytosis activity Standard Deviation 33.1

Adverse Events

514G3 (2 mg/kg) Plus Standard IV Antibiotic Therapy

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

514G3 (10 mg/kg) Plus Standard IV Antibiotic Therapy

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

514G3 (40 mg/kg) Plus Standard IV Antibiotic Therapy

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo Plus Standard IV Antibiotic Therapy

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Phase II: 40 mg/kg Study Drug (514G3) Plus Standard IV Antibiotic

Serious events: 6 serious events

Other events: 19 other events

Deaths: 0 deaths

Phase II: Placebo Plus Standard Intravenous Therapy

Serious events: 5 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	514G3 (2 mg/kg) Plus Standard IV Antibiotic Therapy n=3 participants at risk The participants received single dose of 2 mg/kg study drug (5143G) intravenously (IV) plus standard IV antibiotic therapy.	514G3 (10 mg/kg) Plus Standard IV Antibiotic Therapy n=3 participants at risk The participants received single dose of 10 mg/kg study drug (5143G) intravenously (IV) plus standard IV antibiotic therapy.	514G3 (40 mg/kg) Plus Standard IV Antibiotic Therapy n=6 participants at risk The participants received single dose of 40 mg/kg study drug (5143G) intravenously (IV) plus standard IV antibiotic therapy.	Placebo Plus Standard IV Antibiotic Therapy n=4 participants at risk A single dose of placebo plus standard IV antibiotic therapy.	Phase II: 40 mg/kg Study Drug (514G3) Plus Standard IV Antibiotic n=24 participants at risk The participants received single dose of 40 mg/kg study drug (5143G) plus standard IV therapy.	Phase II: Placebo Plus Standard Intravenous Therapy n=12 participants at risk The participants received single dose of placebo with standard IV therapy.
Vascular disorders HAEMORRHAGE	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Blood and lymphatic system disorders ANAEMIA	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	16.7% 1/6 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	25.0% 1/4 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	4.2% 1/24 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Cardiac disorders ATRIAL FIBRILLATION	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 2/24 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Cardiac disorders CARDIAC ARREST	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 2/24 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Cardiac disorders CARDIAC FAILURE CONGESTIVE	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	33.3% 1/3 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Hepatobiliary disorders HEPATIC CIRRHOSIS	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	4.2% 1/24 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Infections and infestations ABDOMINAL ABSCESS	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	4.2% 1/24 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Infections and infestations ENDOCARDITIS	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	4.2% 1/24 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Infections and infestations LOCALISED INFECTION	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	25.0% 1/4 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Infections and infestations OSTEOMYELITIS	33.3% 1/3 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	25.0% 1/4 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Infections and infestations SEPTIC SHOCK	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	4.2% 1/24 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Infections and infestations SYSTEMIC CANDIDA	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	4.2% 1/24 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Injury, poisoning and procedural complications ROAD TRAFFIC ACCIDENT	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Investigations EJECTION FRACTION DECREASED	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	33.3% 1/3 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Metabolism and nutrition disorders HYPOCALCAEMIA	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	4.2% 1/24 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Nervous system disorders CEREBROVASCULAR ACCIDENT	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	16.7% 1/6 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Nervous system disorders EMBOLIC STROKE	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	4.2% 1/24 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Psychiatric disorders DELIRIUM	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	25.0% 1/4 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 2/24 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	4.2% 1/24 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Vascular disorders AORTIC DISSECTION	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Vascular disorders HYPOTENSION	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	4.2% 1/24 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	4.2% 1/24 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.

Other adverse events

Other adverse events
Measure	514G3 (2 mg/kg) Plus Standard IV Antibiotic Therapy n=3 participants at risk The participants received single dose of 2 mg/kg study drug (5143G) intravenously (IV) plus standard IV antibiotic therapy.	514G3 (10 mg/kg) Plus Standard IV Antibiotic Therapy n=3 participants at risk The participants received single dose of 10 mg/kg study drug (5143G) intravenously (IV) plus standard IV antibiotic therapy.	514G3 (40 mg/kg) Plus Standard IV Antibiotic Therapy n=6 participants at risk The participants received single dose of 40 mg/kg study drug (5143G) intravenously (IV) plus standard IV antibiotic therapy.	Placebo Plus Standard IV Antibiotic Therapy n=4 participants at risk A single dose of placebo plus standard IV antibiotic therapy.	Phase II: 40 mg/kg Study Drug (514G3) Plus Standard IV Antibiotic n=24 participants at risk The participants received single dose of 40 mg/kg study drug (5143G) plus standard IV therapy.	Phase II: Placebo Plus Standard Intravenous Therapy n=12 participants at risk The participants received single dose of placebo with standard IV therapy.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	16.7% 2/12 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Blood and lymphatic system disorders Acute blood loss	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	16.7% 2/12 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Cardiac disorders Acute on chronic congestive heart failure	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	33.3% 1/3 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	25.0% 1/4 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Respiratory, thoracic and mediastinal disorders Acute post-operative respiratory failure	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	33.3% 1/3 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Respiratory, thoracic and mediastinal disorders Acute respiratory insufficiency	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Psychiatric disorders Agitation	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	50.0% 2/4 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Investigations Alanine aminotransferase increased	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 2/24 • Number of events 4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	16.7% 2/12 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Immune system disorders Allergic reaction	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	33.3% 1/3 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Blood and lymphatic system disorders ANAEMIA	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	16.7% 1/6 • Number of events 3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	25.0% 6/24 • Number of events 12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	16.7% 2/12 • Number of events 4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	66.7% 2/3 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	75.0% 3/4 • Number of events 6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	12.5% 3/24 • Number of events 6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	33.3% 4/12 • Number of events 5 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Respiratory, thoracic and mediastinal disorders ATELECTASIS	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	16.7% 1/6 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	4.2% 1/24 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Respiratory, thoracic and mediastinal disorders BILATERAL AIRSPACE DISEASE	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Cardiac disorders CARDIOMEGALY	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Vascular disorders BILATERAL LEG OEDEMA	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	33.3% 1/3 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Musculoskeletal and connective tissue disorders SHOULDER PAIN BILATERAL	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	33.3% 1/3 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Investigations BLOOD BILIRUBIN DECREASED	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 2/24 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Nervous system disorders BURNING SENSATION	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	33.3% 1/3 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Vascular disorders HYPOTENSION ACUTE	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	16.7% 1/6 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	25.0% 1/4 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 2/24 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Infections and infestations PERINEAL CANDIDIASIS	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	33.3% 1/3 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Cardiac disorders CHEST PAIN	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	66.7% 2/3 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	4.2% 1/24 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Infections and infestations COMMON COLD	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Gastrointestinal disorders CONSTIPATION	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	33.3% 1/3 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Investigations CREATININE INCREASED	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	25.0% 1/4 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 2/24 • Number of events 4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Investigations BLOOD CALCIUM DECREASED	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	33.3% 1/3 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	16.7% 4/24 • Number of events 12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Musculoskeletal and connective tissue disorders GRIP STRENGTH DECREASED	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Nervous system disorders DELIRIUM	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	25.0% 1/4 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	4.2% 1/24 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Gastrointestinal disorders DIARRHOEA	66.7% 2/3 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	16.7% 1/6 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	4.2% 1/24 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Respiratory, thoracic and mediastinal disorders COUGH DRY	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	33.3% 1/3 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Vascular disorders DEEP VEIN THROMBOSIS	33.3% 1/3 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	16.7% 2/12 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Investigations ALKALINE PHOSPHATASE INCREASED	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	33.3% 1/3 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	16.7% 1/6 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	25.0% 1/4 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 2/24 • Number of events 5 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	16.7% 2/12 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Investigations BLOOD BILIRUBIN INCREASED	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	33.3% 1/3 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	16.7% 1/6 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	4.2% 1/24 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Investigations BLOOD NEUTROPHILS INCREASED	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 2/24 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Investigations WHITE BLOOD CELL COUNT INCREASED	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	33.3% 1/3 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	25.0% 1/4 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	4.2% 1/24 • Number of events 5 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Infections and infestations EMPYEMA	33.3% 1/3 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Nervous system disorders ENCEPHALOPATHY	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	16.7% 2/12 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Infections and infestations PYREXIA	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	33.3% 2/6 • Number of events 3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	25.0% 1/4 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	4.2% 1/24 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Skin and subcutaneous tissue disorders RASH PAPULAR	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Vascular disorders FLUSHING	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	16.7% 1/6 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
General disorders MALAISE	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	25.0% 1/4 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
General disorders PAIN	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	25.0% 1/4 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	16.7% 2/12 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
General disorders ASTHENIA	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Nervous system disorders HEADACHE	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Investigations BLOOD CHLORIDE INCREASED	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	25.0% 1/4 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Investigations FIBRINOGEN INCREASED	33.3% 1/3 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Investigations BLOOD GLUCOSE INCREASED	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	33.3% 1/3 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	20.8% 5/24 • Number of events 12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	16.7% 2/12 • Number of events 8 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Investigations BLOOD POTASSIUM INCREASED	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	66.7% 2/3 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Investigations BLOOD PROTEIN INCREASED	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	25.0% 1/4 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Vascular disorders HYPERTENSION	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	33.3% 1/3 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 2/24 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	16.7% 2/12 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Investigations HYPERVOLAEMIA	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	33.3% 1/3 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	25.0% 1/4 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Investigations HYPONATRAEMIA HYPERVOLAEMIC	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Investigations BLOOD ALBUMIN DECREASED	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	16.7% 1/6 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	20.8% 5/24 • Number of events 14 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Investigations BLOOD CHLORIDE DECREASED	33.3% 1/3 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 2/24 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	16.7% 2/12 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Investigations BLOOD GLUCOSE DECREASED	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	16.7% 1/6 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 2/24 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Investigations BLOOD POTASSIUM DECREASED	33.3% 1/3 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	33.3% 1/3 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	16.7% 1/6 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	25.0% 1/4 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	12.5% 3/24 • Number of events 4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	25.0% 3/12 • Number of events 4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Investigations BLOOD MAGNESIUM DECREASED	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	33.3% 1/3 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	4.2% 1/24 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Investigations BLOOD SODIUM DECREASED	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	25.0% 1/4 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	12.5% 3/24 • Number of events 3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	25.0% 3/12 • Number of events 3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Investigations BLOOD PHOSPHATE DECREASED	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Investigations BLOOD PROTEIN DECREASED	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	33.3% 1/3 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	16.7% 1/6 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 2/24 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Vascular disorders HYPOTENSION	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	16.7% 1/6 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 2/24 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Endocrine disorders HYPOTHYROIDISM	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	16.7% 1/6 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Investigations PLATELET COUNT INCREASED	33.3% 1/3 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	16.7% 1/6 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	25.0% 1/4 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 2/24 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	16.7% 2/12 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	25.0% 1/4 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	4.2% 1/24 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Vascular disorders THROMBOSIS VENA CAVA INFERIOR	33.3% 1/3 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	4.2% 1/24 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
General disorders INFUSION SITE EXTRAVASATION	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	50.0% 3/6 • Number of events 3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Nervous system disorders INSOMNIA	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	16.7% 1/6 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Investigations ASPARTATE AMINOTRANSFERASE DECREASED	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	25.0% 1/4 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	4.2% 1/24 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Investigations BLOOD UREA DECREASED	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 2/24 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Investigations ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Investigations PLATELET COUNT DECREASED	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	25.0% 1/4 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 2/24 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Respiratory, thoracic and mediastinal disorders EPISTAXIS SEVERE	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	33.3% 1/3 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Respiratory, thoracic and mediastinal disorders INTERSTITIAL OEDEMA	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Skin and subcutaneous tissue disorders PRURITUS	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	33.3% 1/3 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Skin and subcutaneous tissue disorders PRESSURE ULCER STAGE II	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	33.3% 1/3 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	4.2% 1/24 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Investigations WHITE BLOOD CELL COUNT DECREASED	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	33.3% 1/3 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	4.2% 1/24 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Investigations ALANINE AMINOTRANSFERASE DECREASED	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	66.7% 2/3 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 2/24 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	25.0% 1/4 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Investigations BLOOD BICARBONATE DECREASED	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	25.0% 1/4 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Investigations LYMPHOCYTE COUNT DECREASED	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 2/24 • Number of events 3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Cardiac disorders Non-sustained ventricular tachycardia	33.3% 1/3 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Infections and infestations Epidural abscess, paraspinal	33.3% 1/3 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
General disorders Phlebitis injection site	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	33.3% 1/3 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Respiratory, thoracic and mediastinal disorders SHORTNESS OF BREATH	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	33.3% 1/3 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Psychiatric disorders ANXIETY	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	33.3% 1/3 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Eye disorders Scleral edema	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	16.7% 1/6 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Eye disorders SCLERAL ICTERUS	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	16.7% 1/6 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Skin and subcutaneous tissue disorders SKIN ULCERATION	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	16.7% 1/6 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Renal and urinary disorders ACUTE KIDNEY INJURY	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	16.7% 1/6 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	4.2% 1/24 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/12 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Cardiac disorders PERICARDIAL EFFUSION	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Cardiac disorders SYSTOLIC DYSFUNCTION	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Musculoskeletal and connective tissue disorders NECK PAIN	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Vascular disorders NECK VENOUS THROMBOSIS	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Musculoskeletal and connective tissue disorders OSTEOMYELITIS	33.3% 1/3 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	4.2% 1/24 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	16.7% 2/12 • Number of events 2 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Musculoskeletal and connective tissue disorders KNEE PAIN	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	4.2% 1/24 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Respiratory, thoracic and mediastinal disorders POSTOPERATIVE RESPIRATORY DISTRESS	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Musculoskeletal and connective tissue disorders MYOSITIS	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Nervous system disorders right arm and shoulder numbness	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Nervous system disorders Right Arm and Shoulder Tingling	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Blood and lymphatic system disorders SPLENOMEGALY	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Respiratory, thoracic and mediastinal disorders SORE THROAT	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Cardiac disorders TACHYCARDIA	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Musculoskeletal and connective tissue disorders RIGHT CHEST WALL MASS	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.
Cardiac disorders CHEST WALL PAIN	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/3 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/6 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/4 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	0.00% 0/24 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.	8.3% 1/12 • Number of events 1 • The adverse event data were collected between Day 0 and 30 days following the last administration of the investigational drug. This includes a follow-up period of 14 days after dosing to assess for Dose Limiting Toxicities (DLTs) and adverse events (AEs), with a Day 14 visit as an outpatient if the patient is discharged from the hospital prior to Day 14.

Additional Information

Haritha Pallapotu

XBiotech USA, Inc.

Phone: 512-386-2992

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place