Trial Outcomes & Findings for Study to Investigate the Safety and Activity of Aldoxorubicin Plus Ifosfamide/Mesna in Subjects With Metastatic Soft Tissue Sarcoma (NCT NCT02235701)

Last Updated: 2024-05-29

Results Overview

The primary objective of this study is to determine the preliminary safety of administration of aldoxorubicin in combination with ifosfamide in subjects with metastatic, locally advanced, or unresectable soft tissue sarcoma as measured by the frequency and severity of adverse events (AEs). The following assessments were used to determine if subjects had adverse events: * vitals signs (systolic/diastolic blood pressure, pulse, respiration, temperature, weight, and body surface area) * physical examination * laboratory tests (chemistry, hematology, urinalysis, anion gap) additionally, the following scans were performed to determine adverse events: * ECHO / MUGA * ECG

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

70 participants

Primary outcome timeframe

Treatment was planned to continue until tumor progression is observed, subject asks to withdraw, or unacceptable toxicity occurs (up to 766 days).

Results posted on

2024-05-29

Participant Flow

Participant milestones

Participant milestones
Measure	170 mg/m^2 Aldoxorubicin aldoxorubicin: administered at 170 mg/m\^2 plus 1 gm/m2/day ifosfamide by continuous intravenous infusion for up to 14 days on Day 1 every 28 days	250 mg/m^2 Aldoxorubicin aldoxorubicin: administered at 250 mg/m\^2 plus 1 gm/m\^2/day ifosfamide by continuous intravenous infusion for up to 14 days on Day 1 every 28 days
Overall Study STARTED	6	64
Overall Study COMPLETED	6	64
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Investigate the Safety and Activity of Aldoxorubicin Plus Ifosfamide/Mesna in Subjects With Metastatic Soft Tissue Sarcoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	170 mg/m^2 Aldoxorubicin n=6 Participants 170 mg/m\^2 aldoxorubicin: administered at 170 mg/m\^2 plus 1 gm/m\^2/day ifosfamide by continuous intravenous infusion for up to 14 days on Day 1 every 28 days	250 mg/m^2 Aldoxorubicin n=64 Participants 250 mg/m\^2 aldoxorubicin: administered at 250 mg/m\^2 plus 1 gm/m\^2/day ifosfamide by continuous intravenous infusion for up to 14 days on Day 1 every 28 days	Total n=70 Participants Total of all reporting groups
Age, Continuous	40 years STANDARD_DEVIATION 14.14 • n=5 Participants	51.5 years STANDARD_DEVIATION 15.05 • n=7 Participants	50.5 years STANDARD_DEVIATION 15.22 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	28 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	36 Participants n=7 Participants	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	24 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	40 Participants n=7 Participants	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	56 Participants n=7 Participants	61 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Histologically or cytologically confirmed, locally advanced, unresectable, and/or metastatic STS	6 Participants n=5 Participants	64 Participants n=7 Participants	70 Participants n=5 Participants

PRIMARY outcome

Timeframe: Treatment was planned to continue until tumor progression is observed, subject asks to withdraw, or unacceptable toxicity occurs (up to 766 days).

Outcome measures

Outcome measures
Measure	170 mg/m^2 Aldoxorubicin n=6 Participants aldoxorubicin: administered at 170 mg/m\^2 plus 1 gm/m\^2/day ifosfamide by continuous intravenous infusion for up to 14 days on Day 1 every 28 days	250 mg/m^2 Aldoxorubicin n=64 Participants aldoxorubicin: administered at 250 mg/m\^2 plus 1 gm/m\^2/day ifosfamide by continuous intravenous infusion for up to 14 days on Day 1 every 28 days
Number of Adverse Events in Participants	6 Participants	64 Participants

Adverse Events

170 mg/m^2 Aldoxorubicin

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

250 mg/m^2 Aldoxorubicin

Serious events: 31 serious events

Other events: 64 other events

Deaths: 16 deaths

Serious adverse events

Other adverse events

Additional Information

Sandeep Bobby Reddy, Chief Medical Officer

ImmunityBio

Phone: 855-797-9277

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	170 mg/m^2 Aldoxorubicin n=6 participants at risk aldoxorubicin: administered at 170 mg/m\^2 plus 1 gm/m2/day ifosfamide by continuous intravenous infusion for up to 14 days on Day 1 every 28 days	250 mg/m^2 Aldoxorubicin n=64 participants at risk aldoxorubicin: administered at 250 mg/m\^2 plus 1 gm/m2/day ifosfamide by continuous intravenous infusion for up to 14 days on Day 1 every 28 days
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	1.6% 1/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Infections and infestations Enterobacter Bacteremia	16.7% 1/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	0.00% 0/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Infections and infestations Enterobacter sepsis	16.7% 1/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	0.00% 0/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Infections and infestations Sepsis	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	6.2% 4/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Infections and infestations Urinary tract infection	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	1.6% 1/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Infections and infestations Cellulitis	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	1.6% 1/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Infections and infestations Klebsiella bacteremia	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	1.6% 1/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Infections and infestations Pneumonia	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	3.1% 2/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Infections and infestations Device related sepsis	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	1.6% 1/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Infections and infestations Viral syndrome	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	1.6% 1/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	1.6% 1/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	1.6% 1/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor necrosis	16.7% 1/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	0.00% 0/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcomatosis	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	1.6% 1/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Nervous system disorders Cerebrovascular accident	16.7% 1/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	0.00% 0/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Nervous system disorders Spinal cord compression	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	1.6% 1/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Nervous system disorders Neurotoxicity	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	1.6% 1/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Renal and urinary disorders Acute kidney injury	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	1.6% 1/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	1.6% 1/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	1.6% 1/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	1.6% 1/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	1.6% 1/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	3.1% 2/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Vascular disorders Hypertension	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	1.6% 1/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Gastrointestinal disorders Stomatitis	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	1.6% 1/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Infections and infestations Cellulitis of male external genitalia	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	1.6% 1/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	4.7% 3/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	3.1% 2/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Injury, poisoning and procedural complications Wound necrosis	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	1.6% 1/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Psychiatric disorders Mental status changes	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	1.6% 1/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	1.6% 1/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	4.7% 3/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Blood and lymphatic system disorders Febrile neutropenia	16.7% 1/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	12.5% 8/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Blood and lymphatic system disorders Anemia	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	9.4% 6/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Blood and lymphatic system disorders Neutropenia	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	1.6% 1/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Eye disorders Ophthalmoplegia	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	1.6% 1/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Gastrointestinal disorders Small bowel obstruction	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	1.6% 1/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Gastrointestinal disorders Nausea	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	1.6% 1/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Gastrointestinal disorders Vomiting	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	3.1% 2/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
General disorders Pyrexia	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	4.7% 3/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.

Other adverse events
Measure	170 mg/m^2 Aldoxorubicin n=6 participants at risk aldoxorubicin: administered at 170 mg/m\^2 plus 1 gm/m2/day ifosfamide by continuous intravenous infusion for up to 14 days on Day 1 every 28 days	250 mg/m^2 Aldoxorubicin n=64 participants at risk aldoxorubicin: administered at 250 mg/m\^2 plus 1 gm/m2/day ifosfamide by continuous intravenous infusion for up to 14 days on Day 1 every 28 days
Blood and lymphatic system disorders Anaemia	100.0% 6/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	87.5% 56/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Blood and lymphatic system disorders Febrile neutropenia	16.7% 1/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	14.1% 9/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Blood and lymphatic system disorders Leukopenia	16.7% 1/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	9.4% 6/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Blood and lymphatic system disorders Neutropenia	100.0% 6/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	93.8% 60/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Blood and lymphatic system disorders Splenomegaly	16.7% 1/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	0.00% 0/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Blood and lymphatic system disorders Thrombocytopenia	83.3% 5/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	45.3% 29/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Cardiac disorders Tachycardia	16.7% 1/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	12.5% 8/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	10.9% 7/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Gastrointestinal disorders Constipation	33.3% 2/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	17.2% 11/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Gastrointestinal disorders Dyspepsia	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	6.2% 4/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Gastrointestinal disorders Nausea	66.7% 4/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	70.3% 45/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Gastrointestinal disorders Stomatitis	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	15.6% 10/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Gastrointestinal disorders Vomiting	16.7% 1/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	43.8% 28/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
General disorders Fatigue	100.0% 6/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	81.2% 52/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
General disorders Oedema Peripheral	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	7.8% 5/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
General disorders Pyrexia	16.7% 1/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	20.3% 13/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Hepatobiliary disorders Hypoalbuminaemia	16.7% 1/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	0.00% 0/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Infections and infestations Enterobacter Bacteraemia	16.7% 1/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	0.00% 0/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Infections and infestations Enterobacter Sepsis	16.7% 1/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	0.00% 0/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Infections and infestations Sepsis	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	7.8% 5/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Infections and infestations Upper respiratory tract infection	16.7% 1/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	4.7% 3/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Infections and infestations Staphylococcal infection	33.3% 2/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	3.1% 2/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Infections and infestations Varicella zoster virus infection	16.7% 1/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	0.00% 0/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Injury, poisoning and procedural complications Procedural pain	16.7% 1/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	10.9% 7/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Investigations Alanine aminotransferase increased	16.7% 1/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	1.6% 1/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Metabolism and nutrition disorders Decreased appetite	16.7% 1/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	10.9% 7/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	12.5% 8/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Metabolism and nutrition disorders Hyperglycaemia	16.7% 1/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	6.2% 4/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Metabolism and nutrition disorders Hypoalbuminaemia	16.7% 1/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	12.5% 8/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	6.2% 4/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Metabolism and nutrition disorders Hypokalaemia	50.0% 3/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	31.2% 20/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	17.2% 11/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Musculoskeletal and connective tissue disorders Back pain	16.7% 1/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	12.5% 8/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	10.9% 7/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour necrosis	16.7% 1/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	0.00% 0/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Nervous system disorders Cerebrovascular accident	16.7% 1/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	0.00% 0/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Nervous system disorders Headache	16.7% 1/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	4.7% 3/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Nervous system disorders Neurotoxicity	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	6.2% 4/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Psychiatric disorders Anxiety	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	15.6% 10/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.
Psychiatric disorders Insomnia	0.00% 0/6 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.	18.8% 12/64 • All adverse events (AEs) that occurred after any administration of the study medication were to be followed until the event resolved, or until 30 days after the last dose of study medication. All SAEs that occurred during the course of the study or within 30 days of the last administration of study medication were to be reported, up to 766 days.