Trial Outcomes & Findings for Trial of CPX-351 in Adult Patients With First Relapse Acute Myeloid Leukemia (AML) (NCT NCT00822094)
NCT ID: NCT00822094
Last Updated: 2017-11-24
Results Overview
The proportion of subjects surviving at 1 year was evaluated separately for each arm by the number of subjects alive at 1 year divided by the total number of subjects.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
126 participants
Primary outcome timeframe
Up to 1 year from randomization
Results posted on
2017-11-24
Participant Flow
Participant milestones
| Measure |
CPX-351
First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion
|
Salvage Therapy
First induction: Investigator's choice salvage therapy administered according to local practice Second induction: Investigator's choice salvage therapy administered according to local practice Consolidation(s): Investigator's choice consolidation therapy administered according to local practice
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
45
|
|
Overall Study
COMPLETED
|
37
|
20
|
|
Overall Study
NOT COMPLETED
|
44
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of CPX-351 in Adult Patients With First Relapse Acute Myeloid Leukemia (AML)
Baseline characteristics by cohort
| Measure |
CPX-351
n=81 Participants
First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion
|
Salvage Therapy
n=44 Participants
First induction: Investigator's choice salvage therapy administered according to local practice Second induction: Investigator's choice salvage therapy administered according to local practice Consolidation(s): Investigator's choice consolidation therapy administered according to local practice
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.4 years
STANDARD_DEVIATION 11.57 • n=5 Participants
|
51.8 years
STANDARD_DEVIATION 11.54 • n=7 Participants
|
50.2 years
STANDARD_DEVIATION 11.57 • n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 year from randomizationPopulation: Efficacy Evaluable Analysis Set - All randomized participants who received at least one dose of study medication.
The proportion of subjects surviving at 1 year was evaluated separately for each arm by the number of subjects alive at 1 year divided by the total number of subjects.
Outcome measures
| Measure |
CPX-351
n=81 Participants
First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion
|
Salvage Therapy
n=44 Participants
First induction: Investigator's choice salvage therapy administered according to local practice Second induction: Investigator's choice salvage therapy administered according to local practice Consolidation(s): Investigator's choice consolidation therapy administered according to local practice
|
|---|---|---|
|
Proportion of Subjects Surviving at 1 Year
|
29 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Following 1st induction, following 2nd induction if applicablePopulation: Efficacy Evaluable Analysis Set: All randomized participants who received at least one dose of study medication.
Outcome measures
| Measure |
CPX-351
n=81 Participants
First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion
|
Salvage Therapy
n=44 Participants
First induction: Investigator's choice salvage therapy administered according to local practice Second induction: Investigator's choice salvage therapy administered according to local practice Consolidation(s): Investigator's choice consolidation therapy administered according to local practice
|
|---|---|---|
|
Complete Remission Rate
|
30 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Up to 1 year from randomizationPopulation: Efficacy Evaluable Analysis Set: All randomized participants who received at least one dose of study medication.
Progression EFS median
Outcome measures
| Measure |
CPX-351
n=81 Participants
First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion
|
Salvage Therapy
n=44 Participants
First induction: Investigator's choice salvage therapy administered according to local practice Second induction: Investigator's choice salvage therapy administered according to local practice Consolidation(s): Investigator's choice consolidation therapy administered according to local practice
|
|---|---|---|
|
Event Free Survival
|
75 days
Interval 43.0 to 128.0
|
43 days
Interval 24.0 to 70.0
|
SECONDARY outcome
Timeframe: Following achievement of CR and up to 1 year from randomizationPopulation: Efficacy Evaluable Analysis Set: All randomized participants who received at least one dose of study medication.
Remission duration was measured from the time the criteria for CR were first met until the first date that disease relapse was objectively documented or until subject death.
Outcome measures
| Measure |
CPX-351
n=81 Participants
First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion
|
Salvage Therapy
n=44 Participants
First induction: Investigator's choice salvage therapy administered according to local practice Second induction: Investigator's choice salvage therapy administered according to local practice Consolidation(s): Investigator's choice consolidation therapy administered according to local practice
|
|---|---|---|
|
Remission Duration
|
301 days
Interval 35.0 to 345.0
|
259 days
Interval 47.0 to 354.0
|
SECONDARY outcome
Timeframe: Up to 1 year from randomizationPopulation: Efficacy Evaluable Analysis Set: All randomized participants who received at least one dose of study medication.
Patients with Aplasia During Study
Outcome measures
| Measure |
CPX-351
n=81 Participants
First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion
|
Salvage Therapy
n=44 Participants
First induction: Investigator's choice salvage therapy administered according to local practice Second induction: Investigator's choice salvage therapy administered according to local practice Consolidation(s): Investigator's choice consolidation therapy administered according to local practice
|
|---|---|---|
|
Rate of Aplasia
|
62 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Up to 1 year from randomizationPopulation: Efficacy Evaluable Analysis Set: All randomized participants who received at least one dose of study medication.
Number of patients transferred for stem cell transplant
Outcome measures
| Measure |
CPX-351
n=81 Participants
First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion
|
Salvage Therapy
n=44 Participants
First induction: Investigator's choice salvage therapy administered according to local practice Second induction: Investigator's choice salvage therapy administered according to local practice Consolidation(s): Investigator's choice consolidation therapy administered according to local practice
|
|---|---|---|
|
Rate of Stem Cell Transplant
|
38 Participants
|
21 Participants
|
Adverse Events
CPX-351
Serious events: 53 serious events
Other events: 81 other events
Deaths: 0 deaths
Salvage Therapy
Serious events: 22 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CPX-351
n=81 participants at risk
First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion
|
Salvage Therapy
n=44 participants at risk
First induction: Investigator's choice salvage therapy administered according to local practice Second induction: Investigator's choice salvage therapy administered according to local practice Consolidation(s): Investigator's choice consolidation therapy administered according to local practice
|
|---|---|---|
|
General disorders
Disease Progression
|
0.00%
0/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
General disorders
Extravasation
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
2/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
General disorders
Chest Pain
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
General disorders
Death
|
0.00%
0/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Neutropenic Colitis
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Enterocolitis
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
2.5%
2/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Bone Marrow Necrosis
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
8.6%
7/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
4.5%
2/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Cardiac disorders
Cardiac Failure
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Cardiac disorders
Left Ventricular Dysfunction
|
0.00%
0/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Cardiac disorders
Pericardial Effusion
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Cardiac disorders
Sinus Bradycardia
|
0.00%
0/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Eye disorders
Conjunctival Haemorrhage
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
General disorders
Mucosal Inflammation
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
General disorders
Multi-Organ Failure
|
0.00%
0/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
General disorders
Pain
|
0.00%
0/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
General disorders
Pyrexia
|
2.5%
2/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
General disorders
Sudden Cardiac Death
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Infections and infestations
Bacteraemia
|
13.6%
11/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
13.6%
6/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Infections and infestations
Catheter Site Infection
|
0.00%
0/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Infections and infestations
Cellulitis
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Infections and infestations
Clostridium Difficile Colitis
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Infections and infestations
Diverticulitis
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Infections and infestations
Fungaemia
|
0.00%
0/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Infections and infestations
Gastrointestinal Bacterial Infection
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Infections and infestations
Herpes Zoster Disseminated
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Infections and infestations
Pharyngitis
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Infections and infestations
Pneumonia
|
8.6%
7/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
4.5%
2/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Infections and infestations
Pneumonia Fungal
|
0.00%
0/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Infections and infestations
Pseudomonas Infection
|
0.00%
0/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Infections and infestations
Respiratory Syncytial Virus Infection
|
0.00%
0/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Infections and infestations
Sepsis
|
9.9%
8/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Infections and infestations
Septic Shock
|
4.9%
4/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Infections and infestations
Sinusitis
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Infections and infestations
Urinary Tract Infection
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Investigations
Ejection Fraction Decreased
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukaemia
|
4.9%
4/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
4.5%
2/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Nervous system disorders
Cerebral Haemorrhage
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Nervous system disorders
Syncope
|
0.00%
0/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Renal Failure Acute
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infiltration
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
2.5%
2/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.5%
2/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Vascular disorders
Deep Vein Thrombosis
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Vascular disorders
Hypotension
|
2.5%
2/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Vascular disorders
Subclavian Vein Thrombosis
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Vascular disorders
Thrombophlebitis
|
1.2%
1/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
Other adverse events
| Measure |
CPX-351
n=81 participants at risk
First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion
|
Salvage Therapy
n=44 participants at risk
First induction: Investigator's choice salvage therapy administered according to local practice Second induction: Investigator's choice salvage therapy administered according to local practice Consolidation(s): Investigator's choice consolidation therapy administered according to local practice
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.2%
5/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
50.6%
41/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
29.5%
13/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
8.6%
7/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.2%
5/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.7%
3/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
6.8%
3/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Cardiac disorders
Pericardial Effusion
|
6.2%
5/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Cardiac disorders
Tachycardia
|
18.5%
15/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
15.9%
7/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
6.2%
5/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
4.5%
2/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal Distension
|
16.0%
13/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
4.5%
2/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal Pain
|
21.0%
17/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
20.5%
9/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
3.7%
3/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
6.8%
3/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
42.0%
34/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
27.3%
12/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
38.3%
31/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
59.1%
26/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Dry Mouth
|
6.2%
5/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
6.8%
3/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.9%
8/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
11.4%
5/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Flatulence
|
7.4%
6/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
0.00%
0/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Haemorrhoids
|
4.9%
4/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
6.8%
3/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Mouth Haemorrhage
|
6.2%
5/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
6.8%
3/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
54.3%
44/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
52.3%
23/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Oral Pain
|
4.9%
4/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
6.8%
3/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Stomatitis
|
9.9%
8/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
13.6%
6/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
43.2%
35/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
36.4%
16/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
General disorders
Asthenia
|
13.6%
11/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
20.5%
9/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
General disorders
Catheter Site Erythema
|
8.6%
7/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
9.1%
4/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
General disorders
Catheter Site Pain
|
17.3%
14/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
6.8%
3/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
General disorders
Chest Pain
|
7.4%
6/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
General disorders
Chills
|
29.6%
24/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
22.7%
10/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
General disorders
Fatigue
|
40.7%
33/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
36.4%
16/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
General disorders
Mucosal Inflammation
|
18.5%
15/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
20.5%
9/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
General disorders
Oedema Peripheral
|
42.0%
34/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
25.0%
11/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
General disorders
Pain
|
11.1%
9/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
9.1%
4/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
General disorders
Pyrexia
|
29.6%
24/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
29.5%
13/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Immune system disorders
Drug Hypersensitivity
|
4.9%
4/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
9.1%
4/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Infections and infestations
Bacteraemia
|
4.9%
4/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
6.8%
3/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Infections and infestations
Cellulitis
|
9.9%
8/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
9.1%
4/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Infections and infestations
Pneumonia
|
13.6%
11/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
9.1%
4/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
6.8%
3/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Allergic Transfusion Reaction
|
6.2%
5/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
4.9%
4/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
6.8%
3/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Transfusion Reaction
|
3.7%
3/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
13.6%
6/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Investigations
Weight Decreased
|
6.2%
5/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
4.5%
2/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
32.1%
26/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
34.1%
15/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.9%
4/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
6.8%
3/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
6.8%
3/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
23.5%
19/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
11.4%
5/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
9.9%
8/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
6.8%
3/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypnoatraemia
|
4.9%
4/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
9.1%
4/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
8.6%
7/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.3%
14/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
6.8%
3/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
8.6%
7/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.4%
6/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
4.5%
2/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Nervous system disorders
Dizziness
|
19.8%
16/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
11.4%
5/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Nervous system disorders
Dysgeusia
|
4.9%
4/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
11.4%
5/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
28.4%
23/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
34.1%
15/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
8.6%
7/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Nervous system disorders
Syncope
|
2.5%
2/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
6.8%
3/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
24.7%
20/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
13.6%
6/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Depression
|
16.0%
13/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
4.5%
2/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
17.3%
14/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
22.7%
10/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Renal and urinary disorders
Dysuria
|
7.4%
6/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
6.8%
3/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
7.4%
6/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
6.2%
5/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.9%
25/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
22.7%
10/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
27.2%
22/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
9.1%
4/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
13.6%
11/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
27.3%
12/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
12.3%
10/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
16.0%
13/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
13.6%
6/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
14.8%
12/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
4.5%
2/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
7.4%
6/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
8.6%
7/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.5%
2/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
11.4%
5/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.2%
5/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
4.5%
2/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
11.1%
9/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
6.8%
3/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
7.4%
6/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
6.8%
3/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
12.3%
10/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
13.6%
6/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.5%
15/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
9.1%
4/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
45.7%
37/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
25.0%
11/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Vascular disorders
Deep Vein Thrombosis
|
6.2%
5/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Vascular disorders
Hypertension
|
13.6%
11/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
13.6%
6/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Vascular disorders
Hypotension
|
22.2%
18/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
13.6%
6/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
4.9%
4/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
6.8%
3/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Infections and infestations
Enterococcal bacteraemia
|
3.7%
3/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
9.1%
4/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
7.4%
6/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
2.5%
2/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
6.8%
3/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.5%
15/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
13.6%
6/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.9%
4/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
6.8%
3/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
11.1%
9/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.3%
10/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
13.6%
6/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
7.4%
6/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.2%
5/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
6.2%
5/81 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
2.3%
1/44 • Continually assessed during Treatment Period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Safety Population: All randomized participants who received at least one dose of study medication.
|
Additional Information
Associate Director, Clinical Trial Disclosure & Transparency
Jazz Pharmaceuticals
Phone: (215) 832-3750
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place