Trial Outcomes & Findings for An Open Label Phase II Pharmacokinetic and Pharmacodynamic Assessment of the Potential for QTc Prolongation Following First Induction Treatment With CPX-351 (Cytarabine:Daunorubicin) Liposome Injection in Acute Leukemias and MDS Patients (NCT NCT02238925)
NCT ID: NCT02238925
Last Updated: 2017-11-30
Results Overview
Time-matched QTcF Changes From Baseline after the start of first infusion
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
21 days
Results posted on
2017-11-30
Participant Flow
Participant milestones
| Measure |
CPX-351
Single Arm Study (Patients may receive up to 2 Inductions and up to 4 Consolidations):
Induction 1: CPX-351 will be given intravenously at 100units/m2 on days 1, 3, and 5 over a 90 minute infusion.
Induction 2: CPX-351 will be given intravenously at 100units/m2 on days 1 and 3 over a 90 minute infusion.
Consolidations: CPX-351 will be given intravenously at 65units/m2 on days 1 and 3 over a 90 minute infusion.
CPX-351
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Open Label Phase II Pharmacokinetic and Pharmacodynamic Assessment of the Potential for QTc Prolongation Following First Induction Treatment With CPX-351 (Cytarabine:Daunorubicin) Liposome Injection in Acute Leukemias and MDS Patients
Baseline characteristics by cohort
| Measure |
CPX-351
n=26 Participants
Single Arm Study (Patients may receive up to 2 Inductions and up to 4 Consolidations):
Induction 1: CPX-351 will be given intravenously at 100units/m2 on days 1, 3, and 5 over a 90 minute infusion.
Induction 2: CPX-351 will be given intravenously at 100units/m2 on days 1 and 3 over a 90 minute infusion.
Consolidations: CPX-351 will be given intravenously at 65units/m2 on days 1 and 3 over a 90 minute infusion.
CPX-351
|
|---|---|
|
Age, Continuous
|
65.2 years
STANDARD_DEVIATION 9.31 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 21 daysPopulation: All subjects who received any dose of study drug and had at least 1 time-matched change from baseline in ECG parameters.
Time-matched QTcF Changes From Baseline after the start of first infusion
Outcome measures
| Measure |
CPX-351
n=26 Participants
Single Arm Study (Patients may receive up to 2 Inductions and up to 4 Consolidations):
Induction 1: CPX-351 will be given intravenously at 100units/m2 on days 1, 3, and 5 over a 90 minute infusion.
Induction 2: CPX-351 will be given intravenously at 100units/m2 on days 1 and 3 over a 90 minute infusion.
Consolidations: CPX-351 will be given intravenously at 65units/m2 on days 1 and 3 over a 90 minute infusion.
CPX-351
|
|---|---|
|
Effect of CPX-351 on Cardiac Ventricular Repolarization (QTcF)
Time-point 0.75 h
|
0.6 msecs
Standard Deviation 15.13
|
|
Effect of CPX-351 on Cardiac Ventricular Repolarization (QTcF)
Time-point 1.5 h
|
-1.2 msecs
Standard Deviation 13.30
|
|
Effect of CPX-351 on Cardiac Ventricular Repolarization (QTcF)
Time-point 2 h
|
4.3 msecs
Standard Deviation 15.96
|
|
Effect of CPX-351 on Cardiac Ventricular Repolarization (QTcF)
Time-point 3 h
|
5.3 msecs
Standard Deviation 15.17
|
|
Effect of CPX-351 on Cardiac Ventricular Repolarization (QTcF)
Time-point 4 h
|
8.0 msecs
Standard Deviation 11.69
|
|
Effect of CPX-351 on Cardiac Ventricular Repolarization (QTcF)
Time-point 6 h
|
-0.1 msecs
Standard Deviation 11.24
|
|
Effect of CPX-351 on Cardiac Ventricular Repolarization (QTcF)
Time-point 8 h
|
4.8 msecs
Standard Deviation 8.52
|
|
Effect of CPX-351 on Cardiac Ventricular Repolarization (QTcF)
Time-point 12 h
|
-2.3 msecs
Standard Deviation 10.43
|
|
Effect of CPX-351 on Cardiac Ventricular Repolarization (QTcF)
Time-point 24 h
|
-6.2 msecs
Standard Deviation 13.91
|
SECONDARY outcome
Timeframe: During 1st induction (up to 5 days)Population: All subjects who received at least 1 dose of study drug and copper data were collected.
Change from Baseline to Induction 1, Day 5
Outcome measures
| Measure |
CPX-351
n=24 Participants
Single Arm Study (Patients may receive up to 2 Inductions and up to 4 Consolidations):
Induction 1: CPX-351 will be given intravenously at 100units/m2 on days 1, 3, and 5 over a 90 minute infusion.
Induction 2: CPX-351 will be given intravenously at 100units/m2 on days 1 and 3 over a 90 minute infusion.
Consolidations: CPX-351 will be given intravenously at 65units/m2 on days 1 and 3 over a 90 minute infusion.
CPX-351
|
|---|---|
|
Serum Copper Levels Change From Baseline
|
64.95 μg/dL
Standard Deviation 51.119
|
SECONDARY outcome
Timeframe: Following 1st induction, following 2nd induction if applicablePopulation: Efficacy population: All subjects who received at least 1 dose of study drug.
Outcome measures
| Measure |
CPX-351
n=26 Participants
Single Arm Study (Patients may receive up to 2 Inductions and up to 4 Consolidations):
Induction 1: CPX-351 will be given intravenously at 100units/m2 on days 1, 3, and 5 over a 90 minute infusion.
Induction 2: CPX-351 will be given intravenously at 100units/m2 on days 1 and 3 over a 90 minute infusion.
Consolidations: CPX-351 will be given intravenously at 65units/m2 on days 1 and 3 over a 90 minute infusion.
CPX-351
|
|---|---|
|
Complete Response Rate
|
8 Participants
|
SECONDARY outcome
Timeframe: Induction 1, Day 5Outcome measures
| Measure |
CPX-351
n=26 Participants
Single Arm Study (Patients may receive up to 2 Inductions and up to 4 Consolidations):
Induction 1: CPX-351 will be given intravenously at 100units/m2 on days 1, 3, and 5 over a 90 minute infusion.
Induction 2: CPX-351 will be given intravenously at 100units/m2 on days 1 and 3 over a 90 minute infusion.
Consolidations: CPX-351 will be given intravenously at 65units/m2 on days 1 and 3 over a 90 minute infusion.
CPX-351
|
|---|---|
|
Tmax
Cytarabine
|
2.00 hours
Interval 0.75 to 8.33
|
|
Tmax
Ara-U
|
8.00 hours
Interval 5.78 to 8.33
|
|
Tmax
Daunorubicin
|
2.00 hours
Interval 0.75 to 6.02
|
|
Tmax
Daunorubicinol
|
26.00 hours
Interval 1.5 to 48.0
|
SECONDARY outcome
Timeframe: Induction 1, Day 5Outcome measures
| Measure |
CPX-351
n=26 Participants
Single Arm Study (Patients may receive up to 2 Inductions and up to 4 Consolidations):
Induction 1: CPX-351 will be given intravenously at 100units/m2 on days 1, 3, and 5 over a 90 minute infusion.
Induction 2: CPX-351 will be given intravenously at 100units/m2 on days 1 and 3 over a 90 minute infusion.
Consolidations: CPX-351 will be given intravenously at 65units/m2 on days 1 and 3 over a 90 minute infusion.
CPX-351
|
|---|---|
|
Cmax
Cytarabine
|
62200 ng/ml
Standard Deviation 20900
|
|
Cmax
Ara-U
|
1240 ng/ml
Standard Deviation 252
|
|
Cmax
Daunorubicin
|
26000 ng/ml
Standard Deviation 8510
|
|
Cmax
Daunorubicinol
|
147 ng/ml
Standard Deviation 52.3
|
Adverse Events
CPX-351
Serious events: 8 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CPX-351
n=26 participants at risk
Single Arm Study (Patients may receive up to 2 Inductions and up to 4 Consolidations):
Induction 1: CPX-351 will be given intravenously at 100units/m2 on days 1, 3, and 5 over a 90 minute infusion.
Induction 2: CPX-351 will be given intravenously at 100units/m2 on days 1 and 3 over a 90 minute infusion.
Consolidations: CPX-351 will be given intravenously at 65units/m2 on days 1 and 3 over a 90 minute infusion.
CPX-351
|
|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
26.9%
7/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ileus
|
3.8%
1/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Infections and infestations
Catheter Site Infection
|
3.8%
1/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Infections and infestations
Lung Infection
|
3.8%
1/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Infections and infestations
Meningitis Bacterial
|
3.8%
1/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Infections and infestations
Pathogen Resistance
|
3.8%
1/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
3.8%
1/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Infections and infestations
Pulmonary Mycosis
|
3.8%
1/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
3.8%
1/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Investigations
Ejection Fraction Decreased
|
3.8%
1/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukamia Recurrent
|
3.8%
1/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
3.8%
1/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.8%
1/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
Other adverse events
| Measure |
CPX-351
n=26 participants at risk
Single Arm Study (Patients may receive up to 2 Inductions and up to 4 Consolidations):
Induction 1: CPX-351 will be given intravenously at 100units/m2 on days 1, 3, and 5 over a 90 minute infusion.
Induction 2: CPX-351 will be given intravenously at 100units/m2 on days 1 and 3 over a 90 minute infusion.
Consolidations: CPX-351 will be given intravenously at 65units/m2 on days 1 and 3 over a 90 minute infusion.
CPX-351
|
|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
65.4%
17/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Cardiac disorders
Sinus Tachycardia
|
19.2%
5/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
15.4%
4/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Eye disorders
Blepharospasm
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Eye disorders
Conjunctival Haemorrhage
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Eye disorders
Dry Eye
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Eye disorders
Vitreous Floaters
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
53.8%
14/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
46.2%
12/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
42.3%
11/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
38.5%
10/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal Pain
|
23.1%
6/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gingival Bleeding
|
15.4%
4/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
11.5%
3/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
11.5%
3/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Faecal Incontinence
|
11.5%
3/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
11.5%
3/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Cheilitis
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gingival Pain
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
53.8%
14/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
General disorders
Oedema Peripheral
|
38.5%
10/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
General disorders
Chills
|
26.9%
7/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
23.1%
6/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
General disorders
Gait Disturbance
|
11.5%
3/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
General disorders
Mucosal Inflammation
|
11.5%
3/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
General disorders
Non-Cardiac Chest Pain
|
11.5%
3/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
General disorders
Nodule
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Infections and infestations
Bacteraemia
|
11.5%
3/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
11.5%
3/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Infections and infestations
Clostridium Difficile Colitis
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Infections and infestations
Device Related Infection
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Infections and infestations
Folliculitis
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
11.5%
3/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Excoriation
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Investigations
Human Rhinovirus Test Positive
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Investigations
Viral Test Positive
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Investigations
Weight Decreased
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Investigations
Weight Increased
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
46.2%
12/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Fluid Overload
|
11.5%
3/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Fluid Retention
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
23.1%
6/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
23.1%
6/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
19.2%
5/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
11.5%
3/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
11.5%
3/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain In Jaw
|
11.5%
3/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
42.3%
11/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
19.2%
5/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness Postural
|
11.5%
3/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Nervous system disorders
Tremor
|
11.5%
3/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Nervous system disorders
Ataxia
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Nervous system disorders
Sinus Headache
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
42.3%
11/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Psychiatric disorders
Confusional State
|
23.1%
6/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
15.4%
4/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Psychiatric disorders
Agitation
|
11.5%
3/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Psychiatric disorders
Delirium
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Psychiatric disorders
Sleep Disorder
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Renal and urinary disorders
Chromaturia
|
15.4%
4/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
15.4%
4/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary Incontinence
|
15.4%
4/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
11.5%
3/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Renal and urinary disorders
Micturition Urgency
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary Retention
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
34.6%
9/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
26.9%
7/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
26.9%
7/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
23.1%
6/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
19.2%
5/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
15.4%
4/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
15.4%
4/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
15.4%
4/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
11.5%
3/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
11.5%
3/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
11.5%
3/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
11.5%
3/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Mass
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-Airway Cough Syndrome
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
19.2%
5/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
15.4%
4/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
15.4%
4/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.4%
4/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.4%
4/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
11.5%
3/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
11.5%
3/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
11.5%
3/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
11.5%
3/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Blood Blister
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash Macular
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin Mass
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
30.8%
8/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
15.4%
4/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Vascular disorders
Flushing
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
|
Vascular disorders
Haematoma
|
7.7%
2/26 • Adverse events were recorded from the start of infusion to the last day of the study period, whereas Serious Adverse Events were reported from the start of infusion until 30 days after completion of the study period.
The Safety population included subjects receiving at least 1 dose of study drug.
|
Additional Information
Associate Director, Clinical Trial Disclosure & Transparency
Jazz Pharmaceuticals
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place