Trial Outcomes & Findings for Safety Study of Ornithine Phenylacetate to Treat Patients With Acute Liver Failure/Severe Acute Liver Injury (NCT NCT01548690)

NCT ID: NCT01548690

Last Updated: 2018-10-30

Results Overview

To evaluate the safety and tolerability of OCR-002 in patients with acute liver failure/severe acute liver injury

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

47 participants

Primary outcome timeframe

30 Days

Results posted on

2018-10-30

Participant Flow

Participant milestones

Participant milestones
Measure	Maximum Dose Level 3.33 g/24h Initial infusion of study drug at 0.139 g/h for the first 12 hours (approximately 3.33 g/24h) and maintained at this rate for up to 120 hours.	Maximum Dose Level 6.65 g/24h Initial infusion of study drug at a dose of 0.139 g/h for the first 12 hours (approximately 3.33 g/24h); dose increased to 0.277 g/h for the remaining 108 hours (approximately 6.65 g/24h) for a total treatment period of up to 120 hours.	Maximum Dose Level 10 g/24h Initial infusion of study drug at a dose of 0.139 g/h for the first 12 hours (approximately 3.33 g/24h); dose increased to 0.277 g/h for the next 12 hours; dose then increased to 0.416 g/h (approximately 10 g/24h) and maintained at this rate for the remaining 96 hours for a total treatment period of up to 120 hours.	Maximum Dose Level 20g/24h Study drug infused at a dose of 20g/24h from initiation of infusion for a maximum time of up to 120 hours.
Overall Study STARTED	9	10	13	15
Overall Study Evaluable (72 Hours on Infusion)	6	6	12	12
Overall Study COMPLETED	9	7	8	10
Overall Study NOT COMPLETED	0	3	5	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety Study of Ornithine Phenylacetate to Treat Patients With Acute Liver Failure/Severe Acute Liver Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Maximum Dose Level 3.33 g/24h n=9 Participants Initial infusion of study drug at 0.139 g/h for the first 12 hours (approximately 3.33 g/24h) and maintained at this rate for up to 120 hours.	Maximum Dose Level 6.65 g/24h n=10 Participants Initial infusion of study drug at a dose of 0.139 g/h for the first 12 hours (approximately 3.33 g/24h); dose increased to 0.277 g/h for the remaining 108 hours (approximately 6.65 g/24h) for a total treatment period of up to 120 hours.	Maximum Dose Level 10 g/24h n=13 Participants Initial infusion of study drug at a dose of 0.139 g/h for the first 12 hours (approximately 3.33 g/24h); dose increased to 0.277 g/h for the next 12 hours; dose then increased to 0.416 g/h (approximately 10 g/24h) and maintained at this rate for the remaining 96 hours for a total treatment period of up to 120 hours.	Maximum Dose Level 20g/24h n=15 Participants Study drug infused at a dose of 20g/24h from initiation of infusion for up to 120 hours.	Total n=47 Participants Total of all reporting groups
Age, Continuous	32.0 years n=99 Participants	30.0 years n=107 Participants	42.0 years n=206 Participants	35.0 years n=7 Participants	35.0 years n=31 Participants
Sex: Female, Male Female	6 Participants n=99 Participants	5 Participants n=107 Participants	9 Participants n=206 Participants	11 Participants n=7 Participants	31 Participants n=31 Participants
Sex: Female, Male Male	3 Participants n=99 Participants	5 Participants n=107 Participants	4 Participants n=206 Participants	4 Participants n=7 Participants	16 Participants n=31 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants	0 Participants n=7 Participants	2 Participants n=31 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants	3 Participants n=107 Participants	2 Participants n=206 Participants	5 Participants n=7 Participants	11 Participants n=31 Participants
Race (NIH/OMB) White	7 Participants n=99 Participants	7 Participants n=107 Participants	8 Participants n=206 Participants	10 Participants n=7 Participants	32 Participants n=31 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	0 Participants n=7 Participants	2 Participants n=31 Participants
Region of Enrollment United States	9 Participants n=99 Participants	10 Participants n=107 Participants	13 Participants n=206 Participants	15 Participants n=7 Participants	47 Participants n=31 Participants

PRIMARY outcome

Timeframe: 30 Days

Population: All patients who consented to the study, completed screening and had the intravenous infusion of study drug initiated

To evaluate the safety and tolerability of OCR-002 in patients with acute liver failure/severe acute liver injury

Outcome measures

Outcome measures
Measure	Maximum Dose Level 3.33 g/24h n=9 Participants Initial infusion of study drug at 0.139 g/h for the first 12 hours (approximately 3.33 g/24h) and maintained at this rate for up to 120 hours.	Maximum Dose Level 6.65 g/24h n=10 Participants Initial infusion of study drug at a dose of 0.139 g/h for the first 12 hours (approximately 3.33 g/24h); dose increased to 0.277 g/h for the remaining 108 hours (approximately 6.65 g/24h) for a total treatment period of up to 120 hours.	Maximum Dose Level 10 g/24h n=13 Participants Initial infusion of study drug at a dose of 0.139 g/h for the first 12 hours (approximately 3.33 g/24h); dose increased to 0.277 g/h for the next 12 hours; dose then increased to 0.416 g/h (approximately 10 g/24h) and maintained at this rate for the remaining 96 hours for a total treatment period of up to 120 hours.	Maximum Dose Level 20g/24h n=15 Participants Study drug infused at a dose of 20g/24h from initiation of infusion for a maximum time of up to 120 hours.
Number of Participants That do Not Tolerate the Administered Dose and Had Grade 3 or 4 Treatment Emergent Adverse Events as a Measure of Safety and Tolerability	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 Hours after last infusion

Population: All patients who consented to the study and had the intravenous infusion of study drug initiated for up to 120 hours and had results available from serum and urine samples measuring the pharmacokinetic (PK), pharmacodynamic profile (phenylacetic acid (PAA), ornithine) and urinary phenylacetylglutamine (PAGN) levels.

To evaluate the steady state pharmacokinetic and pharmacodynamic profile of OCR-002 in patients with impaired and intact renal function using urinary phenylacetylglutamine (PAGN) as a surrogate marker

Outcome measures

Outcome measures
Measure	Maximum Dose Level 3.33 g/24h n=8 Participants Initial infusion of study drug at 0.139 g/h for the first 12 hours (approximately 3.33 g/24h) and maintained at this rate for up to 120 hours.	Maximum Dose Level 6.65 g/24h n=8 Participants Initial infusion of study drug at a dose of 0.139 g/h for the first 12 hours (approximately 3.33 g/24h); dose increased to 0.277 g/h for the remaining 108 hours (approximately 6.65 g/24h) for a total treatment period of up to 120 hours.	Maximum Dose Level 10 g/24h n=13 Participants Initial infusion of study drug at a dose of 0.139 g/h for the first 12 hours (approximately 3.33 g/24h); dose increased to 0.277 g/h for the next 12 hours; dose then increased to 0.416 g/h (approximately 10 g/24h) and maintained at this rate for the remaining 96 hours for a total treatment period of up to 120 hours.	Maximum Dose Level 20g/24h n=15 Participants Study drug infused at a dose of 20g/24h from initiation of infusion for a maximum time of up to 120 hours.
Measurement of OCR-002 Plasma Concentration	65.6 micrograms per millileter Standard Deviation 82.5	32.2 micrograms per millileter Standard Deviation 31.4	33.4 micrograms per millileter Standard Deviation 24.1	104.9 micrograms per millileter Standard Deviation 104.5

SECONDARY outcome

Timeframe: Baseline and 72 Hours

Population: All patients who consented to the study and had the intravenous infusion of study drug initiated for up to 72 hours and available venous or arterial ammonia levels.

To evaluate the effect of OCR-002 on ammonia levels in patients with acute liver failure/severe acute liver injury

Outcome measures

Outcome measures
Measure	Maximum Dose Level 3.33 g/24h n=6 Participants Initial infusion of study drug at 0.139 g/h for the first 12 hours (approximately 3.33 g/24h) and maintained at this rate for up to 120 hours.	Maximum Dose Level 6.65 g/24h n=8 Participants Initial infusion of study drug at a dose of 0.139 g/h for the first 12 hours (approximately 3.33 g/24h); dose increased to 0.277 g/h for the remaining 108 hours (approximately 6.65 g/24h) for a total treatment period of up to 120 hours.	Maximum Dose Level 10 g/24h n=10 Participants Initial infusion of study drug at a dose of 0.139 g/h for the first 12 hours (approximately 3.33 g/24h); dose increased to 0.277 g/h for the next 12 hours; dose then increased to 0.416 g/h (approximately 10 g/24h) and maintained at this rate for the remaining 96 hours for a total treatment period of up to 120 hours.	Maximum Dose Level 20g/24h n=12 Participants Study drug infused at a dose of 20g/24h from initiation of infusion for a maximum time of up to 120 hours.
Change in Ammonia	41.2 Percent Change Standard Deviation 21.1	16.6 Percent Change Standard Deviation 51.4	41.8 Percent Change Standard Deviation 35.8	38.4 Percent Change Standard Deviation 31.1

SECONDARY outcome

Timeframe: 120 hours from start of infusion

Population: All patients who consented to the study and had the intravenous infusion of study drug initiated and West Haven Criteria (WHC) for Hepatic Encephalopathy assessment scores available.

The West Haven Criteria (WHC) for Hepatic Encephalopathy measures the severity of encephalopathy and patient's level of consciousness. The scale ranges from 0 to 4; a minimum score of 0 represents a better outcome, and a maximum total score of 4 represents a worse outcome. A score of 0 corresponds to normal consciousness and behavior and normal neurological examination. A score of 1 corresponds to mild lack of awareness, shortened attention span, and impaired addition or subtraction; mild asterixis or tremor. A score of 2 corresponds to lethargy, disorientated or inappropriate behavior, obvious asterixis; slurred speech. A score of 3 corresponds to somnolent but arousable, gross disorientation or bizarre behavior, muscle rigidity and clonus; hyperreflexia. A score of 4 corresponds to coma and decerebrate posturing.

Outcome measures

Outcome measures
Measure	Maximum Dose Level 3.33 g/24h n=5 Participants Initial infusion of study drug at 0.139 g/h for the first 12 hours (approximately 3.33 g/24h) and maintained at this rate for up to 120 hours.	Maximum Dose Level 6.65 g/24h n=5 Participants Initial infusion of study drug at a dose of 0.139 g/h for the first 12 hours (approximately 3.33 g/24h); dose increased to 0.277 g/h for the remaining 108 hours (approximately 6.65 g/24h) for a total treatment period of up to 120 hours.	Maximum Dose Level 10 g/24h n=11 Participants Initial infusion of study drug at a dose of 0.139 g/h for the first 12 hours (approximately 3.33 g/24h); dose increased to 0.277 g/h for the next 12 hours; dose then increased to 0.416 g/h (approximately 10 g/24h) and maintained at this rate for the remaining 96 hours for a total treatment period of up to 120 hours.	Maximum Dose Level 20g/24h n=13 Participants Study drug infused at a dose of 20g/24h from initiation of infusion for a maximum time of up to 120 hours.
Neurological Function Measured by the West Haven Criteria (WHC) for Hepatic Encephalopathy	2.4 units on a scale Standard Deviation 1.9	3.2 units on a scale Standard Deviation 2.0	1.6 units on a scale Standard Deviation 1.4	1.8 units on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: 30 Days

Population: All patients who consented to the study and had the intravenous infusion of study drug initiated and Orientation log (O-log) assessment scores available.

The orientation log focuses on orientation to place, time, and circumstance. There are 10 items on the orientation log, which are scored 0-3. A spontaneous correct response is awarded 3 points. A spontaneous response that is lacking or incorrect, but a correct response is provided following a logical cue is awarded 2 points. A score of 1 is given if spontaneous and cued responses are lacking or incorrect, but a correct response is provided in a recognition format. A score of 0 is given if the spontaneous, cued, or recognition format does not generate a correct answer. Scores from the 10 items are summed and the final score ranges from 0 to 30.

Outcome measures

Outcome measures
Measure	Maximum Dose Level 3.33 g/24h n=5 Participants Initial infusion of study drug at 0.139 g/h for the first 12 hours (approximately 3.33 g/24h) and maintained at this rate for up to 120 hours.	Maximum Dose Level 6.65 g/24h n=3 Participants Initial infusion of study drug at a dose of 0.139 g/h for the first 12 hours (approximately 3.33 g/24h); dose increased to 0.277 g/h for the remaining 108 hours (approximately 6.65 g/24h) for a total treatment period of up to 120 hours.	Maximum Dose Level 10 g/24h n=6 Participants Initial infusion of study drug at a dose of 0.139 g/h for the first 12 hours (approximately 3.33 g/24h); dose increased to 0.277 g/h for the next 12 hours; dose then increased to 0.416 g/h (approximately 10 g/24h) and maintained at this rate for the remaining 96 hours for a total treatment period of up to 120 hours.	Maximum Dose Level 20g/24h n=4 Participants Study drug infused at a dose of 20g/24h from initiation of infusion for a maximum time of up to 120 hours.
Neurological Function Measured by the Orientation Log (O-log)	23.8 units on a scale Standard Deviation 0.4	24.0 units on a scale Standard Deviation 0.0	24.0 units on a scale Standard Deviation 0.0	24.0 units on a scale Standard Deviation 0.0

Adverse Events

Maximum Dose Level 3.33 g/24h

Serious events: 5 serious events

Other events: 8 other events

Deaths: 2 deaths

Maximum Dose Level 6.65 g/24h

Serious events: 3 serious events

Other events: 5 other events

Deaths: 3 deaths

Maximum Dose Level 10 g/24h

Serious events: 4 serious events

Other events: 9 other events

Deaths: 2 deaths

Maximum Dose Level 20g/24h

Serious events: 4 serious events

Other events: 7 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Maximum Dose Level 3.33 g/24h n=9 participants at risk Initial infusion of study drug at 0.139 g/h for the first 12 hours (approximately 3.33 g/24h) and maintained at this rate for up to 120 hours.	Maximum Dose Level 6.65 g/24h n=10 participants at risk Initial infusion of study drug at a dose of 0.139 g/h for the first 12 hours (approximately 3.33 g/24h); dose increased to 0.277 g/h for the remaining 108 hours (approximately 6.65 g/24h) for a total treatment period of 120 hours.	Maximum Dose Level 10 g/24h n=13 participants at risk Initial infusion of study drug at a dose of 0.139 g/h for the first 12 hours (approximately 3.33 g/24h); dose increased to 0.277 g/h for the next 12 hours; dose then increased to 0.416 g/h (approximately 10 g/24h) and maintained at this rate for the remaining 96 hours for a total treatment period of 120 hours.	Maximum Dose Level 20g/24h n=15 participants at risk Study drug infused at a dose of 20g/24h from initiation of infusion for a maximum time of 120 hours.
Vascular disorders Deep vein thrombosis	11.1% 1/9 • Number of events 1 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	0.00% 0/10 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	0.00% 0/13 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	0.00% 0/15 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.
Respiratory, thoracic and mediastinal disorders Pneumonia	22.2% 2/9 • Number of events 2 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	0.00% 0/10 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	0.00% 0/13 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	0.00% 0/15 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.
Vascular disorders Circulatory collapse	11.1% 1/9 • Number of events 1 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	0.00% 0/10 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	0.00% 0/13 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	0.00% 0/15 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.
Hepatobiliary disorders Acute hepatic failure	11.1% 1/9 • Number of events 1 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	10.0% 1/10 • Number of events 1 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	15.4% 2/13 • Number of events 2 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	0.00% 0/15 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.
Vascular disorders Compartment syndrome	11.1% 1/9 • Number of events 1 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	0.00% 0/10 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	0.00% 0/13 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	0.00% 0/15 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.
Nervous system disorders Cerebellar infarction	0.00% 0/9 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	10.0% 1/10 • Number of events 1 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	0.00% 0/13 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	0.00% 0/15 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.
Vascular disorders Subdural hematoma	0.00% 0/9 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	10.0% 1/10 • Number of events 1 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	0.00% 0/13 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	0.00% 0/15 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/9 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	0.00% 0/10 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	7.7% 1/13 • Number of events 1 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	0.00% 0/15 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.
Nervous system disorders Brain edema	0.00% 0/9 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	0.00% 0/10 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	7.7% 1/13 • Number of events 1 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	0.00% 0/15 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.
Infections and infestations Septic shock	0.00% 0/9 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	0.00% 0/10 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	0.00% 0/13 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	6.7% 1/15 • Number of events 1 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.
Vascular disorders Hypotension	0.00% 0/9 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	0.00% 0/10 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	0.00% 0/13 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	13.3% 2/15 • Number of events 2 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.
Nervous system disorders Neurological decompensation	0.00% 0/9 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	0.00% 0/10 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	0.00% 0/13 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	6.7% 1/15 • Number of events 1 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.
Infections and infestations Sepsis	0.00% 0/9 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	0.00% 0/10 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	0.00% 0/13 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	6.7% 1/15 • Number of events 1 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.
General disorders Multi-organ failure	0.00% 0/9 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	0.00% 0/10 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	0.00% 0/13 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.	6.7% 1/15 • Number of events 1 • Serious adverse events & suspected adverse reactions: Collected from the start of the initial study drug infusion through study completion, i.e., Day 30, death, or withdrawal of consent. Non-serious adverse events: Collected from the start of the initial study drug infusion through 24 hours following the final infusion of study drug (typically Day 5) or for 24 hours following the final infusion of study drug for those patients who do not complete the entire course of study drug administration. Medical conditions not present prior to the start of the initial study drug infusion but emerge thereafter are reported, including exacerbation of pre-existing medical conditions \& clinically significant, treatment-emergent lab abnormalities. A safety follow-up visit is performed 30 days after the start of the initial study drug infusion. An independent site monitor performs data verification to ensure all adverse events (AEs) are reported as defined in the protocol.

Other adverse events

Additional Information

William M. Lee, MD

University of Texas Southwestern Medical Center

Phone: (214) 645-6110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place