Trial Outcomes & Findings for Phase III Study of CPX-351 Versus 7+3 in Patients 60-75 Years Old With Untreated High Risk (Secondary) Acute Myeloid Leukemia (NCT NCT01696084)
NCT ID: NCT01696084
Last Updated: 2020-08-10
Results Overview
Overall survival was measured from the date of randomization to death from any cause, subjects not known to have died by the last follow-up were censored on the date they were last known to be alive.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
309 participants
Primary outcome timeframe
From the date of randomization to death from any cause
Results posted on
2020-08-10
Participant Flow
Participant milestones
| Measure |
Arm A (CPX-351)
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
|
Arm B (7+3)
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
|
|---|---|---|
|
Overall Study
STARTED
|
153
|
156
|
|
Overall Study
COMPLETED
|
22
|
10
|
|
Overall Study
NOT COMPLETED
|
131
|
146
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase III Study of CPX-351 Versus 7+3 in Patients 60-75 Years Old With Untreated High Risk (Secondary) Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Arm A (CPX-351)
n=153 Participants
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
|
Arm B (7+3)
n=156 Participants
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
|
Total
n=309 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.8 years
STANDARD_DEVIATION 4.19 • n=5 Participants
|
67.7 years
STANDARD_DEVIATION 4.1 • n=7 Participants
|
67.7 years
STANDARD_DEVIATION 4.14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 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
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
128 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
267 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the date of randomization to death from any causePopulation: Intent-to-Treat (ITT) Population: All participants randomized in the study.
Overall survival was measured from the date of randomization to death from any cause, subjects not known to have died by the last follow-up were censored on the date they were last known to be alive.
Outcome measures
| Measure |
Arm A (CPX-351)
n=153 Participants
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
|
Arm B (7+3)
n=156 Participants
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
|
|---|---|---|
|
Overall Survival
|
9.56 months
Interval 6.6 to 11.86
|
5.95 months
Interval 4.99 to 7.75
|
SECONDARY outcome
Timeframe: Post InductionPopulation: Intent-to-Treat (ITT) Population: All participants randomized in the study.
Complete Remission (CR)
Outcome measures
| Measure |
Arm A (CPX-351)
n=153 Participants
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
|
Arm B (7+3)
n=156 Participants
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
|
|---|---|---|
|
Proportion of Subjects With a Response
|
57 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: From the date of randomization to the date that persistent disease was documented or the date of relapse after CR or death, whichever came firstPopulation: Intent-to-Treat (ITT) Population: All participants randomized in the study.
All randomized subjects were assessed for event-free survival (EFS). EFS was defined as the time from study randomization to the date of induction treatment failure (persistent disease), relapse from CR or CRi or death from any cause, whichever came first. Subjects alive and not known to have any of these events were censored on thee date they were last examined on study.
Outcome measures
| Measure |
Arm A (CPX-351)
n=153 Participants
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
|
Arm B (7+3)
n=156 Participants
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
|
|---|---|---|
|
Event-free Survival
|
2.53 months
Interval 2.07 to 4.99
|
1.31 months
Interval 1.08 to 1.64
|
SECONDARY outcome
Timeframe: From the date of achievement of a remission until the date of relapse or death from any causePopulation: Intent-to-Treat (ITT) Population: All participants randomized in the study.
Only subjects achieving CR or CRi were assessed for remission duration.
Outcome measures
| Measure |
Arm A (CPX-351)
n=153 Participants
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
|
Arm B (7+3)
n=156 Participants
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
|
|---|---|---|
|
Remission Duration
|
6.93 months
Interval 4.6 to 9.23
|
6.11 months
Interval 3.45 to 8.71
|
SECONDARY outcome
Timeframe: Day 14Population: Intent-to-Treat (ITT) Population: All participants randomized in the study.
All randomized subjects with at least 1 evaluable postrandomization bone marrow assessment performed on or after Day 14 after the last induction were assessed for MLFS.
Outcome measures
| Measure |
Arm A (CPX-351)
n=126 Participants
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
|
Arm B (7+3)
n=119 Participants
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
|
|---|---|---|
|
Rate of Achieving Morphologic Leukemia-free State
|
87 Participants
|
66 Participants
|
SECONDARY outcome
Timeframe: Post InductionPopulation: Intent-to-Treat (ITT) Population: All participants randomized in the study.
The number and percentage of subjects transferred for HSCT after induction treatment was recorded.
Outcome measures
| Measure |
Arm A (CPX-351)
n=153 Participants
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
|
Arm B (7+3)
n=156 Participants
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
|
|---|---|---|
|
Proportion of Subjects Receiving a Stem Cell Transplant
|
52 Participants
|
39 Participants
|
Adverse Events
Arm A (CPX-351)
Serious events: 90 serious events
Other events: 152 other events
Deaths: 1 deaths
Arm B (7+3)
Serious events: 65 serious events
Other events: 151 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A (CPX-351)
n=153 participants at risk
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
|
Arm B (7+3)
n=151 participants at risk
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukaemia
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.00%
0/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
1.3%
2/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
7.8%
12/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
5.3%
8/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
2/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Atrial Fibrillation
|
1.3%
2/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
1.3%
2/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Cardiac Failure
|
1.3%
2/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
1.3%
2/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Left Ventricular Dysfunction
|
0.00%
0/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
2.6%
4/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Myocardial Infarction
|
2.0%
3/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Cardiac Arrest
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Cardiomyopathy
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.00%
0/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Cardiotoxicity
|
0.00%
0/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Cytotoxic Cardiomyopathy
|
0.00%
0/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Mitral Valve Incompetence
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Pericarditis
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Tachycardia
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Endocrine disorders
Euthyroid Sick Syndrome
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Eye disorders
Conjunctival Haemorrhage
|
0.00%
0/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
1.3%
2/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Small Intestinal Disorders
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Chron's Disease
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastric Haemorrhage
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gingival Bleeding
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
General disorders
Disease Progression
|
3.9%
6/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
4.0%
6/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
General disorders
Multi-Organ Failure
|
1.3%
2/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
2.6%
4/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
General disorders
Chest Pain
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
General disorders
Chest Discomfort
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
General disorders
Death
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
1.3%
2/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Immune system disorders
Alloimmunisation
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Sepsis
|
7.8%
12/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
3.3%
5/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
6.5%
10/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
4.0%
6/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Bacteraemia
|
2.6%
4/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Cellulitis
|
2.0%
3/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Septic Shock
|
1.3%
2/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
1.3%
2/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Enterococcal Bacteraemia
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
1.3%
2/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
1.3%
2/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Lung Infection
|
0.00%
0/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
1.3%
2/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia Bacterial
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Bacteroides Bacteraemia
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Bronchopulmonary Aspergillosis
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Central Nervous System Infection
|
0.00%
0/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Diverticulitis
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Enterobacter Bacteraemia
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Escherichia Bacteraemia
|
0.00%
0/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Escherichia Sepsis
|
0.00%
0/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Klebsiella Bacteraemia
|
0.00%
0/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Klebsiella Sepsis
|
0.00%
0/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Mycotic Aneurysm
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Neutropenic Infection
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia Fungal
|
0.00%
0/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia Pseudomonas Aeruginosa
|
0.00%
0/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pseudomonal Bacteraemia
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Sinusitis
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Sinusitis Fungal
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Skin Infection
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Staphylococcal Infection
|
0.00%
0/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Streptococcal Sepsis
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Subdural Haemorrhage
|
0.00%
0/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
1.3%
2/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Transfusion Reaction
|
1.3%
2/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Brain Herniation
|
0.00%
0/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.00%
0/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Transfusion-Related Acute Lung Injury
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Investigations
Ejection Fraction Decreased
|
5.9%
9/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
6.0%
9/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Investigations
Enterococcus Test Positive
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Investigations
Fungal Test Positive
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Investigations
Hepatic Enzyme Increased
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Investigations
Klebsiella Test Positive
|
0.00%
0/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Investigations
Pseudomonas Test Positive
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Investigations
Staphylococcus Test Positive
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Investigations
Stenotrophomonas Test Positive
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Investigations
Streptococcus Test Positive
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Lactic Acidosis
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Tumor Lysis Syndrome
|
0.00%
0/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukaemia Recurrent
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Syncope
|
2.6%
4/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Central Nervous System Haemorrhage
|
2.0%
3/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
1.3%
2/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Haemorrhage Intracranial
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Cerebral Infarction
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Convulsion
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Headache
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Presyncope
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Radiculopathy
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Confusional State
|
1.3%
2/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Delirium
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Mental Status Changes
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Renal Failure Acute
|
1.3%
2/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
1.3%
2/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
7.2%
11/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
5.3%
8/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
3.9%
6/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
2.0%
3/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.0%
3/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
2.0%
3/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
2.0%
3/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
1.3%
2/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Haemorrhage
|
0.00%
0/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.66%
1/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypotension
|
0.65%
1/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
0.00%
0/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
Other adverse events
| Measure |
Arm A (CPX-351)
n=153 participants at risk
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
|
Arm B (7+3)
n=151 participants at risk
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
68.0%
104/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
69.5%
105/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Atrial Fibrillation
|
5.2%
8/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
9.9%
15/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Eye disorders
Conjunctival Haemorrhage
|
5.2%
8/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
4.0%
6/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Eye disorders
Vision Blurred
|
6.5%
10/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
1.3%
2/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
45.8%
70/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
68.2%
103/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
49.0%
75/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
55.0%
83/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
42.5%
65/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
39.7%
60/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
25.5%
39/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
21.9%
33/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
21.6%
33/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
19.9%
30/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal Distension
|
11.8%
18/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
11.3%
17/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
11.8%
18/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
7.9%
12/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
9.2%
14/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
10.6%
16/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Mouth Haemorrhage
|
10.5%
16/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
5.3%
8/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dry Mouth
|
7.2%
11/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
7.9%
12/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.2%
14/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
6.0%
9/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
5.9%
9/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
6.6%
10/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gingival Bleeding
|
7.8%
12/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
4.6%
7/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Oral Pain
|
3.3%
5/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
6.6%
10/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
5.9%
9/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
2.6%
4/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
2.6%
4/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
6.0%
9/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Mouth Ulceration
|
5.9%
9/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
1.3%
2/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
General disorders
Oedema Peripheral
|
40.5%
62/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
50.3%
76/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
General disorders
Fatigue
|
34.6%
53/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
35.1%
53/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
General disorders
Chills
|
26.8%
41/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
27.2%
41/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
General disorders
Mucosal Inflammation
|
18.3%
28/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
20.5%
31/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
General disorders
Pyrexia
|
21.6%
33/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
16.6%
25/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
General disorders
Asthenia
|
9.2%
14/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
9.3%
14/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
General disorders
Oedema
|
8.5%
13/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
9.3%
14/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
General disorders
Chest Pain
|
7.2%
11/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
8.6%
13/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
General disorders
Catheter Site Erythema
|
5.9%
9/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
4.6%
7/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
General disorders
Catheter Site Pain
|
7.2%
11/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
2.6%
4/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
General disorders
Chest Discomfort
|
5.2%
8/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
4.0%
6/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
18.3%
28/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
17.2%
26/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Sepsis
|
3.3%
5/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
5.3%
8/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Cellulitis
|
5.9%
9/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
6.6%
10/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Bacteraemia
|
7.8%
12/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
2.6%
4/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Transfusion Reaction
|
8.5%
13/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
9.3%
14/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
7.8%
12/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
6.6%
10/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
7.8%
12/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
5.3%
8/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.9%
9/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
7.3%
11/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Investigations
Weight Decreased
|
3.3%
5/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
7.3%
11/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
32.7%
50/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
41.1%
62/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Fluid Overload
|
8.5%
13/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
12.6%
19/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
14.4%
22/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
13.9%
21/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
13.1%
20/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
9.3%
14/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.7%
24/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
6.0%
9/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
7.8%
12/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
5.3%
8/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
6.5%
10/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
4.0%
6/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
2.6%
4/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
7.3%
11/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.2%
8/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
2.6%
4/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Headache
|
34.6%
53/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
24.5%
37/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
20.9%
32/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
20.5%
31/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dysgeusia
|
7.8%
12/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
7.3%
11/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Somnolence
|
2.0%
3/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
6.0%
9/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
23.5%
36/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
25.2%
38/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Confusional State
|
13.1%
20/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
17.2%
26/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Anxiety
|
15.0%
23/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
14.6%
22/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Delirium
|
3.9%
6/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
8.6%
13/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Depression
|
6.5%
10/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
6.6%
10/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Hallucination
|
3.3%
5/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
5.3%
8/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Agitation
|
5.2%
8/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
2.6%
4/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Renal Failure Acute
|
7.2%
11/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
8.6%
13/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Haematuria
|
6.5%
10/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
6.6%
10/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Dysuria
|
5.2%
8/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
6.6%
10/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
5.2%
8/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
5.3%
8/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Urinary Incontinence
|
5.9%
9/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
4.0%
6/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
51/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
21.9%
33/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
35.3%
54/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
17.9%
27/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
23.5%
36/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
21.2%
32/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
19.6%
30/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
19.9%
30/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
17.0%
26/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
19.2%
29/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
18.3%
28/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
10.6%
16/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
7.8%
12/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
9.3%
14/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
7.8%
12/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
6.6%
10/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
7.8%
12/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
4.6%
7/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.2%
11/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
4.6%
7/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.6%
7/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
6.0%
9/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
4.6%
7/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
5.3%
8/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
5.9%
9/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
2.6%
4/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
28.8%
44/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
21.9%
33/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
13.7%
21/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
11.9%
18/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.0%
23/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
8.6%
13/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
9.2%
14/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
8.6%
13/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
9.2%
14/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
6.6%
10/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.5%
10/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
8.6%
13/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
9.2%
14/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
5.3%
8/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.6%
4/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
11.3%
17/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Blood Blister
|
9.2%
14/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
3.3%
5/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
6.5%
10/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
4.0%
6/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
5.2%
8/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
4.6%
7/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
3.9%
6/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
5.3%
8/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
2.6%
4/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
6.0%
9/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypotension
|
19.6%
30/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
19.9%
30/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypertension
|
19.0%
29/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
15.2%
23/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Vascular disorders
Deep Vein Thrombosis
|
5.2%
8/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
6.0%
9/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Tachycardia
|
14.4%
22/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
11.3%
17/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
5.9%
9/153 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
7.9%
12/151 • Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Safety Population: All randomized participants who received at least one dose of study treatment.
|
Additional Information
Associate Director, Clinical Trial Disclosure & Transparency
Jazz Pharmaceuticals
Phone: 2158709177
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place