Trial Outcomes & Findings for Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML) (NCT NCT03315039)
NCT ID: NCT03315039
Last Updated: 2022-03-10
Results Overview
Number of patients with a dose-limiting toxicity (DLT) at each dose evaluated
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
7 participants
Primary outcome timeframe
Day 28
Results posted on
2022-03-10
Participant Flow
no participants were enrolled in Phase 2
Participant milestones
| Measure |
Dose Level 1: 100 mg/m2/Day Liposomal Annamycin
Liposomal Annamycin: 2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).
|
Dose Level 2: 120 mg/m2/Day Liposomal Annamycin
Liposomal Annamycin: 2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
|
Overall Study
COMPLETED
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML)
Baseline characteristics by cohort
| Measure |
Dose Level 1: 100 mg/m2/Day Liposomal Annamycin
n=4 Participants
Liposomal Annamycin: 2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).
|
Dose Level 2: 120 mg/m2/Day Liposomal Annamycin
n=3 Participants
Liposomal Annamycin: 2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
67.0 years
STANDARD_DEVIATION 6.73 • n=5 Participants
|
57.0 years
STANDARD_DEVIATION 18.19 • n=7 Participants
|
62.7 years
STANDARD_DEVIATION 12.71 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
ECOG Performance Status
ECOG - 0
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
ECOG Performance Status
ECOG - 1
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
ECOG Performance Status
ECOG- 2
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 28Number of patients with a dose-limiting toxicity (DLT) at each dose evaluated
Outcome measures
| Measure |
Dose Level 1: 100 mg/m2/Day Liposomal Annamycin
n=4 Participants
Liposomal Annamycin: 2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).
|
Dose Level 2 : 120 mg/m2/Day Liposomal Annamycin
n=3 Participants
Liposomal Annamycin: 2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).
|
|---|---|---|
|
Dose-limiting Toxicity
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, and 24 hours after the start of liposomal annamycin infusion on Day 1 and Day 3Population: One participant excluded from summary statistics due to high Annamycin concentrations
Area under the plasma concentration - time curve (AUC) of annamycin and its metabolite, annamycinol
Outcome measures
| Measure |
Dose Level 1: 100 mg/m2/Day Liposomal Annamycin
n=6 Participants
Liposomal Annamycin: 2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).
|
Dose Level 2 : 120 mg/m2/Day Liposomal Annamycin
Liposomal Annamycin: 2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).
|
|---|---|---|
|
Pharmacokinetics - Area Under the Plasma Concentration
Annamycin 120 mg/m2 - Day 3
|
2880 hr*ng/ml
Geometric Coefficient of Variation 33.3
|
—
|
|
Pharmacokinetics - Area Under the Plasma Concentration
Annamycinol 100 mg/m2 - Day 1
|
1400 hr*ng/ml
Geometric Coefficient of Variation 43.9
|
—
|
|
Pharmacokinetics - Area Under the Plasma Concentration
Annamycinol 100 mg/m2 - Day 3
|
1520 hr*ng/ml
Geometric Coefficient of Variation 36.7
|
—
|
|
Pharmacokinetics - Area Under the Plasma Concentration
Annamycinol 120 mg/m2 - Day 1
|
1370 hr*ng/ml
Geometric Coefficient of Variation 39.5
|
—
|
|
Pharmacokinetics - Area Under the Plasma Concentration
Annamycinol 120 mg/m2 - Day 3
|
1610 hr*ng/ml
Geometric Coefficient of Variation 67.7
|
—
|
|
Pharmacokinetics - Area Under the Plasma Concentration
Annamycin 100 mg/m2 - Day 1
|
1430 hr*ng/ml
Geometric Coefficient of Variation 19.6
|
—
|
|
Pharmacokinetics - Area Under the Plasma Concentration
Annamycin 100 mg/m2 - Day 3
|
1610 hr*ng/ml
Geometric Coefficient of Variation 22.4
|
—
|
|
Pharmacokinetics - Area Under the Plasma Concentration
Annamycin 120 mg/m2 - Day 1
|
2330 hr*ng/ml
Geometric Coefficient of Variation 42.0
|
—
|
SECONDARY outcome
Timeframe: 15-35 Days after the start of therapyDetermined by acute myeloid leukemia (AML) response rate based on the International Working Group (IWG) Response Criteria in AML (Cheson, 2003). Anti-leukemic Activity measured by bone marrow biopsy/aspirate pre and post treatment.
Outcome measures
| Measure |
Dose Level 1: 100 mg/m2/Day Liposomal Annamycin
n=4 Participants
Liposomal Annamycin: 2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).
|
Dose Level 2 : 120 mg/m2/Day Liposomal Annamycin
n=3 Participants
Liposomal Annamycin: 2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).
|
|---|---|---|
|
Number of Participants With Anti-leukemic Activity
Morphological Leukemia Free State (MLFS)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Anti-leukemic Activity
Treatment Failure (TF)
|
4 Participants
|
2 Participants
|
Adverse Events
100 mg/m2 Dose Level
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
120 mg/m2 Dose Level
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
100 mg/m2 Dose Level
n=4 participants at risk
Liposomal Annamycin: 2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).
|
120 mg/m2 Dose Level
n=3 participants at risk
Liposomal Annamycin: 2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).
|
|---|---|---|
|
General disorders
Flank Pain
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
0.00%
0/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
0.00%
0/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
Other adverse events
| Measure |
100 mg/m2 Dose Level
n=4 participants at risk
Liposomal Annamycin: 2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).
|
120 mg/m2 Dose Level
n=3 participants at risk
Liposomal Annamycin: 2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
75.0%
3/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
100.0%
3/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
0.00%
0/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
0.00%
0/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
2/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Gastrointestinal disorders
Abdominal Pain
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Gastrointestinal disorders
Lip Dry
|
0.00%
0/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Investigations
Platelet count decreased
|
50.0%
2/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
66.7%
2/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Psychiatric disorders
Insomnia
|
50.0%
2/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Psychiatric disorders
Anxiety
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
0.00%
0/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
0.00%
0/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Investigations
White blood cell count decreased
|
50.0%
2/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Investigations
Blood creatinine increased
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Investigations
Neutrophil count decreased
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Investigations
Asparate aminotransferase increased
|
0.00%
0/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Investigations
Blood bilirubin increased
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
0.00%
0/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Investigations
Weight Increased
|
0.00%
0/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Metabolism and nutrition disorders
Decreased apetite
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
50.0%
2/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
0.00%
0/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Metabolism and nutrition disorders
Fluid Overload
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
0.00%
0/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
0.00%
0/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
0.00%
0/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
0.00%
0/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
General disorders
Fatigue
|
50.0%
2/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
0.00%
0/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Nervous system disorders
Dysgeusia
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
0.00%
0/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
0.00%
0/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
0.00%
0/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
0.00%
0/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Skin and subcutaneous tissue disorders
Pain of Skin
|
0.00%
0/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Eye disorders
Visual impairment
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
0.00%
0/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
General disorders
Oedema peripheral
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Infections and infestations
Escherichia bacteraemia
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Infections and infestations
Folliculitis
|
50.0%
2/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
0.00%
0/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Infections and infestations
Diverticulitis
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
0.00%
0/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
0.00%
0/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Injury, poisoning and procedural complications
Skin Wound
|
0.00%
0/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
0.00%
0/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
0.00%
0/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
General disorders
Chills
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
0.00%
0/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
General disorders
Mucosal iflammation
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
0.00%
0/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
General disorders
Pyrexia
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
0.00%
0/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Renal and urinary disorders
Urinary hesitation
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
0.00%
0/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
25.0%
1/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
0.00%
0/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
|
33.3%
1/3 • 39 days after the last dose of study treatment, a total of about 1 year and 10 months since the start of the study.
AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment. Safety population = all participants who received any amount of liposomal annamycin.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place