Trial Outcomes & Findings for A Study to Investigate ALDOXORUBICIN in HIV-infected Subjects With Kaposi's Sarcoma (NCT NCT02029430)

NCT ID: NCT02029430

Last Updated: 2024-06-11

Results Overview

To evaluate the uptake of aldoxorubicin into the tumor and the objective response rate (complete and partial response) using RECIST 1.1 criteria in subjects with HIV-infected with Kaposi's sarcoma. Objective responses will be evaluated using the RECIST 1.1 criteria. Changes (i.e. improvements) in tumor measurements from baseline values will be assigned a status of CR or PR or SD. Objective response measurements will comprise the sum of CR plus PR. Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm). Partial Response (PR): 30% decrease in the sum of the longest diameter of target lesions, from the baseline sum longest diameter.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 15 participants
• Primary outcome timeframe: up to 6 months
• Results posted on: 2024-06-11

Participant Flow

Participant milestones

Measure	50 mg/m^2 Aldoxorubicin 50 mg/m\^2 aldoxorubicin	100 mg/m2 Aldoxorubicin 100 mg/m2 aldoxorubicin	150 mg/m^2 Aldoxorubicin 150 mg/m\^2 aldoxorubicin
Overall Study STARTED	1	7	7
Overall Study COMPLETED	1	7	7
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Investigate ALDOXORUBICIN in HIV-infected Subjects With Kaposi's Sarcoma

Baseline characteristics by cohort

Measure	50 mg/m^2 Aldoxorubicin n=1 Participants 50 mg/m\^2 aldoxorubicin	100 mg/m^2 Aldoxorubicin n=7 Participants 100 mg/m\^2 aldoxorubicin	150 mg/m^2 Aldoxorubicin n=7 Participants 150 mg/m\^2 aldoxorubicin	Total n=15 Participants Total of all reporting groups
Age, Continuous	55.9 years STANDARD_DEVIATION NA • n=93 Participants	36.7 years STANDARD_DEVIATION 10.44 • n=4 Participants	38.3 years STANDARD_DEVIATION 10.87 • n=27 Participants	38.7 years STANDARD_DEVIATION 10.98 • n=483 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Sex: Female, Male Male	1 Participants n=93 Participants	7 Participants n=4 Participants	7 Participants n=27 Participants	15 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=93 Participants	6 Participants n=4 Participants	7 Participants n=27 Participants	14 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	5 Participants n=4 Participants	3 Participants n=27 Participants	8 Participants n=483 Participants
Race (NIH/OMB) White	1 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants	7 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
HIV-Infected Patients with Kaposi's Sarcoma	1 Participants n=93 Participants	7 Participants n=4 Participants	7 Participants n=27 Participants	15 Participants n=483 Participants

PRIMARY outcome

Timeframe: up to 6 months

To evaluate the uptake of aldoxorubicin into the tumor and the objective response rate (complete and partial response) using RECIST 1.1 criteria in subjects with HIV-infected with Kaposi's sarcoma.

Objective responses will be evaluated using the RECIST 1.1 criteria. Changes (i.e. improvements) in tumor measurements from baseline values will be assigned a status of CR or PR or SD. Objective response measurements will comprise the sum of CR plus PR.

Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm).

Partial Response (PR): 30% decrease in the sum of the longest diameter of target lesions, from the baseline sum longest diameter.

Outcome measures

Measure	50 mg/m^2 Aldoxorubicin n=1 Participants 50 mg/m\^2 aldoxorubicin	100 mg/m^2 Aldoxorubicin n=7 Participants 100 mg/m\^2 aldoxorubicin	150 mg/m^2 Aldoxorubicin n=7 Participants 150 mg/m\^2 aldoxorubicin
Objective Response Rate	0 Participants	7 Participants	6 Participants

PRIMARY outcome

Timeframe: 30 days from last dose, up to 199 days

All subjects who receive any amount of ALDOXORUBICIN will be included in the safety analyses, which will include the following:

The incidence, severity, duration, causality, seriousness, and type of AEs and changes in the subject's physical examination, vital signs, and clinical laboratory results.

• vitals signs (systolic/diastolic blood pressure, pulse, respiration, temperature, weight, and body surface area)
• physical examination
• laboratory tests (chemistry, hematology, urinalysis, anion gap)

Outcome measures

Measure	50 mg/m^2 Aldoxorubicin n=1 Participants 50 mg/m\^2 aldoxorubicin	100 mg/m^2 Aldoxorubicin n=7 Participants 100 mg/m\^2 aldoxorubicin	150 mg/m^2 Aldoxorubicin n=7 Participants 150 mg/m\^2 aldoxorubicin
Number of Participants With Treatment-related Toxicities (Adverse Events) in This Subject Population	1 Participants	6 Participants	6 Participants

Adverse Events

50 mg/m^2 Aldoxorubicin

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

100 mg/m^2 Aldoxorubicin

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

150 mg/m^2 Aldoxorubicin

Serious events: 3 serious events

Other events: 7 other events

Deaths: 1 deaths

Serious adverse events

Measure	50 mg/m^2 Aldoxorubicin n=1 participants at risk 50 mg/m\^2 aldoxorubicin	100 mg/m^2 Aldoxorubicin n=7 participants at risk 100 mg/m\^2 aldoxorubicin	150 mg/m^2 Aldoxorubicin n=7 participants at risk 150 mg/m\^2 aldoxorubicin
Nervous system disorders Paraesthesia	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Blood and lymphatic system disorders Neutropenia	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Infections and infestations Acquired immunodeficiency syndrome	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.

Other adverse events

Measure	50 mg/m^2 Aldoxorubicin n=1 participants at risk 50 mg/m\^2 aldoxorubicin	100 mg/m^2 Aldoxorubicin n=7 participants at risk 100 mg/m\^2 aldoxorubicin	150 mg/m^2 Aldoxorubicin n=7 participants at risk 150 mg/m\^2 aldoxorubicin
Blood and lymphatic system disorders Leukopenia	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Blood and lymphatic system disorders Neutropenia	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	28.6% 2/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	28.6% 2/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Cardiac disorders Bundle branch block right	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Cardiac disorders Tachycardia	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Gastrointestinal disorders Diarrhoea	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	57.1% 4/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Gastrointestinal disorders Haematemesis	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Gastrointestinal disorders Haemorrhoids	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Gastrointestinal disorders Lip oedema	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Gastrointestinal disorders Nausea	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Gastrointestinal disorders Oral disorder	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Gastrointestinal disorders Toothache	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	28.6% 2/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Gastrointestinal disorders Vomiting	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
General disorders Chills	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
General disorders Fatigue	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
General disorders Gait disturbance	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
General disorders Influenza like illness	100.0% 1/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
General disorders Local swelling	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
General disorders Mass	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
General disorders Medical device complication	100.0% 1/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
General disorders Oedema peripheral	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
General disorders Peripheral swelling	100.0% 1/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
General disorders Pyrexia	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	42.9% 3/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Hepatobiliary disorders Acute hepatic failure	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Hepatobiliary disorders Hyperbilirubinaemia	100.0% 1/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Infections and infestations Abscess limb	100.0% 1/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Infections and infestations Acquired immunodeficiency syndrome	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Infections and infestations Candida infection	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	28.6% 2/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Infections and infestations Cellulitis	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Infections and infestations Device related infection	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Infections and infestations Folliculitis	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Infections and infestations Furuncle	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Infections and infestations Hordeolum	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Infections and infestations Salmonellosis	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Infections and infestations Scrotal abscess	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Injury, poisoning and procedural complications Incision site complication	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Injury, poisoning and procedural complications Incision site infection	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Injury, poisoning and procedural complications Injury	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Investigations Alanine amniotransferase increased	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Investigations Blood HIV RNA increased	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Investigations Blood albumin decreased	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Investigations Blood urine	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Investigations Haematocrit decreased	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Investigations Monocyte count increased	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Investigations Neutrophil count decreased	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Investigations Neutrophil count increased	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Investigations Red blood cell count decreased	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Investigations Urine ketone body present	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Investigations Weight increased	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Investigations White blood cell count decreased	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	28.6% 2/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Investigations White blood cell count increased	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	28.6% 2/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	28.6% 2/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	28.6% 2/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Musculoskeletal and connective tissue disorders Axillary mass	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Nervous system disorders Headache	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Nervous system disorders Paraesthesia	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	28.6% 2/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Renal and urinary disorders Chromaturia	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	28.6% 2/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Renal and urinary disorders Proteinuria	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	42.9% 3/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Skin and subcutaneous tissue disorders Cold sweat	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Skin and subcutaneous tissue disorders Dyshidrotic eczema	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Skin and subcutaneous tissue disorders Rash	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	28.6% 2/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Vascular disorders Hot flush	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Vascular disorders Hypertension	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.
Vascular disorders Hypotension	0.00% 0/1 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	0.00% 0/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.	14.3% 1/7 • All AEs that occurred after any administration of the study medication were to be followed until the event resolved, until the subject began alternative treatment, or until the end of the study. All SAEs that occurred during the course of the study or within 30 days of the last administration, up to 199 days.

Additional Information

Sandeep Bobby Reddy, Chief Medical Officer

ImmunityBio

Phone: 855-797-9277

Email: Bobby.Reddy@Immunitybio.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place