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Phase III Study of CPX-351 Versus 7+3 in Patients 60-75 Years Old With Untreated High Risk (Secondary) Acute Myeloid Leukemia (301)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01696084
Recruitment Status : Completed
First Posted : September 28, 2012
Results First Posted : October 2, 2017
Last Update Posted : August 10, 2020
Sponsor:
Collaborator:
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
Jazz Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition High Risk Acute Myeloid Leukemia
Interventions Drug: CPX-351
Drug: 7+3 (cytarabine and daunorubicin)
Enrollment 309
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm A (CPX-351) Arm B (7+3)
Hide Arm/Group Description Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response. Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
Period Title: Overall Study
Started 153 156
Completed 22 10
Not Completed 131 146
Arm/Group Title Arm A (CPX-351) Arm B (7+3) Total
Hide Arm/Group Description Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response. Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response. Total of all reporting groups
Overall Number of Baseline Participants 153 156 309
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 153 participants 156 participants 309 participants
67.8  (4.19) 67.7  (4.1) 67.7  (4.14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 153 participants 156 participants 309 participants
Female
59
  38.6%
60
  38.5%
119
  38.5%
Male
94
  61.4%
96
  61.5%
190
  61.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 153 participants 156 participants 309 participants
American Indian or Alaska Native
1
   0.7%
0
   0.0%
1
   0.3%
Asian
6
   3.9%
2
   1.3%
8
   2.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
   4.6%
6
   3.8%
13
   4.2%
White
128
  83.7%
139
  89.1%
267
  86.4%
More than one race
0
   0.0%
1
   0.6%
1
   0.3%
Unknown or Not Reported
11
   7.2%
8
   5.1%
19
   6.1%
1.Primary Outcome
Title Overall Survival
Hide Description Overall survival was measured from the date of randomization to death from any cause, subjects not known to have died by the last follow-up were censored on the date they were last known to be alive.
Time Frame From the date of randomization to death from any cause
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: All participants randomized in the study.
Arm/Group Title Arm A (CPX-351) Arm B (7+3)
Hide Arm/Group Description:
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
Overall Number of Participants Analyzed 153 156
Median (95% Confidence Interval)
Unit of Measure: months
9.56
(6.60 to 11.86)
5.95
(4.99 to 7.75)
2.Secondary Outcome
Title Proportion of Subjects With a Response
Hide Description Complete Remission (CR)
Time Frame Post Induction
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: All participants randomized in the study.
Arm/Group Title Arm A (CPX-351) Arm B (7+3)
Hide Arm/Group Description:
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
Overall Number of Participants Analyzed 153 156
Measure Type: Count of Participants
Unit of Measure: Participants
57
  37.3%
40
  25.6%
3.Secondary Outcome
Title Event-free Survival
Hide Description All randomized subjects were assessed for event-free survival (EFS). EFS was defined as the time from study randomization to the date of induction treatment failure (persistent disease), relapse from CR or CRi or death from any cause, whichever came first. Subjects alive and not known to have any of these events were censored on thee date they were last examined on study.
Time Frame From the date of randomization to the date that persistent disease was documented or the date of relapse after CR or death, whichever came first
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: All participants randomized in the study.
Arm/Group Title Arm A (CPX-351) Arm B (7+3)
Hide Arm/Group Description:
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
Overall Number of Participants Analyzed 153 156
Median (95% Confidence Interval)
Unit of Measure: months
2.53
(2.07 to 4.99)
1.31
(1.08 to 1.64)
4.Secondary Outcome
Title Remission Duration
Hide Description Only subjects achieving CR or CRi were assessed for remission duration.
Time Frame From the date of achievement of a remission until the date of relapse or death from any cause
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: All participants randomized in the study.
Arm/Group Title Arm A (CPX-351) Arm B (7+3)
Hide Arm/Group Description:
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
Overall Number of Participants Analyzed 153 156
Median (95% Confidence Interval)
Unit of Measure: months
6.93
(4.60 to 9.23)
6.11
(3.45 to 8.71)
5.Secondary Outcome
Title Rate of Achieving Morphologic Leukemia-free State
Hide Description All randomized subjects with at least 1 evaluable postrandomization bone marrow assessment performed on or after Day 14 after the last induction were assessed for MLFS.
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: All participants randomized in the study.
Arm/Group Title Arm A (CPX-351) Arm B (7+3)
Hide Arm/Group Description:
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
Overall Number of Participants Analyzed 126 119
Measure Type: Count of Participants
Unit of Measure: Participants
87
  69.0%
66
  55.5%
6.Secondary Outcome
Title Proportion of Subjects Receiving a Stem Cell Transplant
Hide Description The number and percentage of subjects transferred for HSCT after induction treatment was recorded.
Time Frame Post Induction
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: All participants randomized in the study.
Arm/Group Title Arm A (CPX-351) Arm B (7+3)
Hide Arm/Group Description:
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
Overall Number of Participants Analyzed 153 156
Measure Type: Count of Participants
Unit of Measure: Participants
52
  34.0%
39
  25.0%
Time Frame Adverse events (AE) recorded from the start of the infusion on Day 1 to the last day of the treatment period. SAE recorded from the start of the infusion on Day 1 to 30 days after completion of the treatment period.
Adverse Event Reporting Description Safety Population: All randomized participants who received at least one dose of study treatment.
 
Arm/Group Title Arm A (CPX-351) Arm B (7+3)
Hide Arm/Group Description Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response. Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
All-Cause Mortality
Arm A (CPX-351) Arm B (7+3)
Affected / at Risk (%) Affected / at Risk (%)
Total   1/153 (0.65%)   0/151 (0.00%) 
Hide Serious Adverse Events
Arm A (CPX-351) Arm B (7+3)
Affected / at Risk (%) Affected / at Risk (%)
Total   90/153 (58.82%)   65/151 (43.05%) 
Blood and lymphatic system disorders     
Febrile Neutropenia   12/153 (7.84%)  8/151 (5.30%) 
Anaemia   2/153 (1.31%)  1/151 (0.66%) 
Thrombocytopenia   1/153 (0.65%)  1/151 (0.66%) 
Leukocytosis   0/153 (0.00%)  1/151 (0.66%) 
Neutropenia   1/153 (0.65%)  0/151 (0.00%) 
Pancytopenia   1/153 (0.65%)  0/151 (0.00%) 
Cardiac disorders     
Atrial Fibrillation   2/153 (1.31%)  2/151 (1.32%) 
Cardiac Failure   2/153 (1.31%)  2/151 (1.32%) 
Left Ventricular Dysfunction   0/153 (0.00%)  4/151 (2.65%) 
Myocardial Infarction   3/153 (1.96%)  0/151 (0.00%) 
Cardiac Arrest   1/153 (0.65%)  1/151 (0.66%) 
Cardiac Failure Congestive   1/153 (0.65%)  1/151 (0.66%) 
Cardiomyopathy   1/153 (0.65%)  1/151 (0.66%) 
Acute Myocardial Infarction   0/153 (0.00%)  1/151 (0.66%) 
Cardio-Respiratory Arrest   0/153 (0.00%)  1/151 (0.66%) 
Cardiotoxicity   0/153 (0.00%)  1/151 (0.66%) 
Cytotoxic Cardiomyopathy   0/153 (0.00%)  1/151 (0.66%) 
Mitral Valve Incompetence   1/153 (0.65%)  0/151 (0.00%) 
Pericarditis   1/153 (0.65%)  0/151 (0.00%) 
Supraventricular Tachycardia   0/153 (0.00%)  1/151 (0.66%) 
Tachycardia   1/153 (0.65%)  0/151 (0.00%) 
Ventricular Tachycardia   0/153 (0.00%)  1/151 (0.66%) 
Endocrine disorders     
Euthyroid Sick Syndrome   1/153 (0.65%)  0/151 (0.00%) 
Hypothyroidism   1/153 (0.65%)  0/151 (0.00%) 
Eye disorders     
Conjunctival Haemorrhage   0/153 (0.00%)  1/151 (0.66%) 
Gastrointestinal disorders     
Colitis   0/153 (0.00%)  2/151 (1.32%) 
Small Intestinal Disorders   1/153 (0.65%)  1/151 (0.66%) 
Chron's Disease   1/153 (0.65%)  0/151 (0.00%) 
Dysphagia   1/153 (0.65%)  0/151 (0.00%) 
Gastric Haemorrhage   1/153 (0.65%)  0/151 (0.00%) 
Gingival Bleeding   1/153 (0.65%)  0/151 (0.00%) 
Lower Gastrointestinal Haemorrhage   1/153 (0.65%)  0/151 (0.00%) 
Rectal Haemorrhage   0/153 (0.00%)  1/151 (0.66%) 
General disorders     
Disease Progression   6/153 (3.92%)  6/151 (3.97%) 
Multi-Organ Failure   2/153 (1.31%)  4/151 (2.65%) 
Chest Pain   1/153 (0.65%)  1/151 (0.66%) 
Asthenia   0/153 (0.00%)  1/151 (0.66%) 
Chest Discomfort   1/153 (0.65%)  0/151 (0.00%) 
Death   1/153 (0.65%)  0/151 (0.00%) 
Non-Cardiac Chest Pain   1/153 (0.65%)  0/151 (0.00%) 
Pyrexia   0/153 (0.00%)  1/151 (0.66%) 
Hepatobiliary disorders     
Cholecystitis Acute   2/153 (1.31%)  0/151 (0.00%) 
Bile Duct Stone   1/153 (0.65%)  0/151 (0.00%) 
Immune system disorders     
Alloimmunisation   1/153 (0.65%)  0/151 (0.00%) 
Infections and infestations     
Sepsis   12/153 (7.84%)  5/151 (3.31%) 
Pneumonia   10/153 (6.54%)  6/151 (3.97%) 
Bacteraemia   4/153 (2.61%)  0/151 (0.00%) 
Cellulitis   3/153 (1.96%)  1/151 (0.66%) 
Septic Shock   2/153 (1.31%)  2/151 (1.32%) 
Enterococcal Bacteraemia   1/153 (0.65%)  2/151 (1.32%) 
Staphylococcal Bacteraemia   1/153 (0.65%)  2/151 (1.32%) 
Lung Infection   0/153 (0.00%)  2/151 (1.32%) 
Pneumonia Bacterial   1/153 (0.65%)  1/151 (0.66%) 
Bacteroides Bacteraemia   1/153 (0.65%)  0/151 (0.00%) 
Bronchopulmonary Aspergillosis   1/153 (0.65%)  0/151 (0.00%) 
Central Nervous System Infection   0/153 (0.00%)  1/151 (0.66%) 
Diverticulitis   1/153 (0.65%)  0/151 (0.00%) 
Enterobacter Bacteraemia   1/153 (0.65%)  0/151 (0.00%) 
Escherichia Bacteraemia   0/153 (0.00%)  1/151 (0.66%) 
Escherichia Sepsis   0/153 (0.00%)  1/151 (0.66%) 
Klebsiella Bacteraemia   0/153 (0.00%)  1/151 (0.66%) 
Klebsiella Sepsis   0/153 (0.00%)  1/151 (0.66%) 
Mycotic Aneurysm   1/153 (0.65%)  0/151 (0.00%) 
Neutropenic Infection   1/153 (0.65%)  0/151 (0.00%) 
Pneumonia Fungal   0/153 (0.00%)  1/151 (0.66%) 
Pneumonia Pseudomonas Aeruginosa   0/153 (0.00%)  1/151 (0.66%) 
Pseudomonal Bacteraemia   1/153 (0.65%)  0/151 (0.00%) 
Sinusitis   1/153 (0.65%)  0/151 (0.00%) 
Sinusitis Fungal   1/153 (0.65%)  0/151 (0.00%) 
Skin Infection   1/153 (0.65%)  0/151 (0.00%) 
Staphylococcal Infection   0/153 (0.00%)  1/151 (0.66%) 
Streptococcal Sepsis   1/153 (0.65%)  0/151 (0.00%) 
Urinary Tract Infection   1/153 (0.65%)  0/151 (0.00%) 
Injury, poisoning and procedural complications     
Subdural Haemorrhage   0/153 (0.00%)  2/151 (1.32%) 
Transfusion Reaction   2/153 (1.31%)  0/151 (0.00%) 
Brain Herniation   0/153 (0.00%)  1/151 (0.66%) 
Fall   1/153 (0.65%)  0/151 (0.00%) 
Subdural Haematoma   0/153 (0.00%)  1/151 (0.66%) 
Transfusion-Related Acute Lung Injury   1/153 (0.65%)  0/151 (0.00%) 
Investigations     
Ejection Fraction Decreased   9/153 (5.88%)  9/151 (5.96%) 
Enterococcus Test Positive   1/153 (0.65%)  0/151 (0.00%) 
Fungal Test Positive   1/153 (0.65%)  0/151 (0.00%) 
Hepatic Enzyme Increased   1/153 (0.65%)  0/151 (0.00%) 
Klebsiella Test Positive   0/153 (0.00%)  1/151 (0.66%) 
Pseudomonas Test Positive   1/153 (0.65%)  0/151 (0.00%) 
Staphylococcus Test Positive   1/153 (0.65%)  0/151 (0.00%) 
Stenotrophomonas Test Positive   1/153 (0.65%)  0/151 (0.00%) 
Streptococcus Test Positive   1/153 (0.65%)  0/151 (0.00%) 
Metabolism and nutrition disorders     
Dehydration   1/153 (0.65%)  0/151 (0.00%) 
Lactic Acidosis   1/153 (0.65%)  0/151 (0.00%) 
Tumor Lysis Syndrome   0/153 (0.00%)  1/151 (0.66%) 
Musculoskeletal and connective tissue disorders     
Arthralgia   1/153 (0.65%)  0/151 (0.00%) 
Back Pain   1/153 (0.65%)  0/151 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute Myeloid Leukaemia   1/153 (0.65%)  1/151 (0.66%) 
Leukaemia   0/153 (0.00%)  2/151 (1.32%) 
Acute Myeloid Leukaemia Recurrent   1/153 (0.65%)  0/151 (0.00%) 
Myelodysplastic Syndrome   1/153 (0.65%)  0/151 (0.00%) 
Renal Cell Carcinoma   1/153 (0.65%)  0/151 (0.00%) 
Nervous system disorders     
Syncope   4/153 (2.61%)  0/151 (0.00%) 
Central Nervous System Haemorrhage   3/153 (1.96%)  0/151 (0.00%) 
Cerebral Haemorrhage   1/153 (0.65%)  2/151 (1.32%) 
Haemorrhage Intracranial   1/153 (0.65%)  1/151 (0.66%) 
Carotid Artery Stenosis   1/153 (0.65%)  0/151 (0.00%) 
Cerebral Infarction   1/153 (0.65%)  0/151 (0.00%) 
Convulsion   1/153 (0.65%)  0/151 (0.00%) 
Headache   1/153 (0.65%)  0/151 (0.00%) 
Presyncope   1/153 (0.65%)  0/151 (0.00%) 
Radiculopathy   1/153 (0.65%)  0/151 (0.00%) 
Psychiatric disorders     
Confusional State   2/153 (1.31%)  0/151 (0.00%) 
Delirium   1/153 (0.65%)  0/151 (0.00%) 
Mental Status Changes   1/153 (0.65%)  0/151 (0.00%) 
Renal and urinary disorders     
Renal Failure Acute   2/153 (1.31%)  2/151 (1.32%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory Failure   11/153 (7.19%)  8/151 (5.30%) 
Acute Respiratory Failure   6/153 (3.92%)  3/151 (1.99%) 
Hypoxia   3/153 (1.96%)  3/151 (1.99%) 
Pulmonary Oedema   1/153 (0.65%)  3/151 (1.99%) 
Respiratory Distress   0/153 (0.00%)  2/151 (1.32%) 
Acute Respiratory Distress Syndrome   1/153 (0.65%)  0/151 (0.00%) 
Dyspnoea   1/153 (0.65%)  0/151 (0.00%) 
Epistaxis   1/153 (0.65%)  0/151 (0.00%) 
Hypercapnia   0/153 (0.00%)  1/151 (0.66%) 
Pleural Effusion   0/153 (0.00%)  1/151 (0.66%) 
Pneumonia Aspiration   1/153 (0.65%)  0/151 (0.00%) 
Pneumothorax   1/153 (0.65%)  0/151 (0.00%) 
Pulmonary Embolism   0/153 (0.00%)  1/151 (0.66%) 
Pulmonary Haemorrhage   0/153 (0.00%)  1/151 (0.66%) 
Vascular disorders     
Deep Vein Thrombosis   1/153 (0.65%)  0/151 (0.00%) 
Hypotension   1/153 (0.65%)  0/151 (0.00%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A (CPX-351) Arm B (7+3)
Affected / at Risk (%) Affected / at Risk (%)
Total   152/153 (99.35%)   151/151 (100.00%) 
Blood and lymphatic system disorders     
Febrile Neutropenia   104/153 (67.97%)  105/151 (69.54%) 
Cardiac disorders     
Atrial Fibrillation   8/153 (5.23%)  15/151 (9.93%) 
Tachycardia   22/153 (14.38%)  17/151 (11.26%) 
Eye disorders     
Conjunctival Haemorrhage   8/153 (5.23%)  6/151 (3.97%) 
Vision Blurred   10/153 (6.54%)  2/151 (1.32%) 
Gastrointestinal disorders     
Diarrhoea   70/153 (45.75%)  103/151 (68.21%) 
Nausea   75/153 (49.02%)  83/151 (54.97%) 
Constipation   65/153 (42.48%)  60/151 (39.74%) 
Vomiting   39/153 (25.49%)  33/151 (21.85%) 
Abdominal Pain   33/153 (21.57%)  30/151 (19.87%) 
Abdominal Distension   18/153 (11.76%)  17/151 (11.26%) 
Haemorrhoids   18/153 (11.76%)  12/151 (7.95%) 
Stomatitis   14/153 (9.15%)  16/151 (10.60%) 
Mouth Haemorrhage   16/153 (10.46%)  8/151 (5.30%) 
Dry Mouth   11/153 (7.19%)  12/151 (7.95%) 
Dyspepsia   14/153 (9.15%)  9/151 (5.96%) 
Dysphagia   9/153 (5.88%)  10/151 (6.62%) 
Gingival Bleeding   12/153 (7.84%)  7/151 (4.64%) 
Oral Pain   5/153 (3.27%)  10/151 (6.62%) 
Abdominal Pain Upper   9/153 (5.88%)  4/151 (2.65%) 
Gastrooesophageal Reflux Disease   4/153 (2.61%)  9/151 (5.96%) 
Mouth Ulceration   9/153 (5.88%)  2/151 (1.32%) 
General disorders     
Oedema Peripheral   62/153 (40.52%)  76/151 (50.33%) 
Fatigue   53/153 (34.64%)  53/151 (35.10%) 
Chills   41/153 (26.80%)  41/151 (27.15%) 
Mucosal Inflammation   28/153 (18.30%)  31/151 (20.53%) 
Pyrexia   33/153 (21.57%)  25/151 (16.56%) 
Asthenia   14/153 (9.15%)  14/151 (9.27%) 
Oedema   13/153 (8.50%)  14/151 (9.27%) 
Chest Pain   11/153 (7.19%)  13/151 (8.61%) 
Catheter Site Erythema   9/153 (5.88%)  7/151 (4.64%) 
Catheter Site Pain   11/153 (7.19%)  4/151 (2.65%) 
Chest Discomfort   8/153 (5.23%)  6/151 (3.97%) 
Infections and infestations     
Pneumonia   28/153 (18.30%)  26/151 (17.22%) 
Sepsis   5/153 (3.27%)  8/151 (5.30%) 
Cellulitis   9/153 (5.88%)  10/151 (6.62%) 
Bacteraemia   12/153 (7.84%)  4/151 (2.65%) 
Injury, poisoning and procedural complications     
Transfusion Reaction   13/153 (8.50%)  14/151 (9.27%) 
Procedural Pain   12/153 (7.84%)  10/151 (6.62%) 
Fall   12/153 (7.84%)  8/151 (5.30%) 
Contusion   9/153 (5.88%)  11/151 (7.28%) 
Investigations     
Weight Decreased   5/153 (3.27%)  11/151 (7.28%) 
Metabolism and nutrition disorders     
Decreased Appetite   50/153 (32.68%)  62/151 (41.06%) 
Fluid Overload   13/153 (8.50%)  19/151 (12.58%) 
Musculoskeletal and connective tissue disorders     
Back Pain   22/153 (14.38%)  21/151 (13.91%) 
Pain In Extremity   20/153 (13.07%)  14/151 (9.27%) 
Arthralgia   24/153 (15.69%)  9/151 (5.96%) 
Neck Pain   12/153 (7.84%)  8/151 (5.30%) 
Musculoskeletal Pain   10/153 (6.54%)  6/151 (3.97%) 
Muscular Weakness   4/153 (2.61%)  11/151 (7.28%) 
Myalgia   8/153 (5.23%)  4/151 (2.65%) 
Nervous system disorders     
Headache   53/153 (34.64%)  37/151 (24.50%) 
Dizziness   32/153 (20.92%)  31/151 (20.53%) 
Dysgeusia   12/153 (7.84%)  11/151 (7.28%) 
Somnolence   3/153 (1.96%)  9/151 (5.96%) 
Psychiatric disorders     
Insomnia   36/153 (23.53%)  38/151 (25.17%) 
Confusional State   20/153 (13.07%)  26/151 (17.22%) 
Anxiety   23/153 (15.03%)  22/151 (14.57%) 
Delirium   6/153 (3.92%)  13/151 (8.61%) 
Depression   10/153 (6.54%)  10/151 (6.62%) 
Hallucination   5/153 (3.27%)  8/151 (5.30%) 
Agitation   8/153 (5.23%)  4/151 (2.65%) 
Renal and urinary disorders     
Renal Failure Acute   11/153 (7.19%)  13/151 (8.61%) 
Haematuria   10/153 (6.54%)  10/151 (6.62%) 
Dysuria   8/153 (5.23%)  10/151 (6.62%) 
Pollakiuria   8/153 (5.23%)  8/151 (5.30%) 
Urinary Incontinence   9/153 (5.88%)  6/151 (3.97%) 
Respiratory, thoracic and mediastinal disorders     
Cough   51/153 (33.33%)  33/151 (21.85%) 
Epistaxis   54/153 (35.29%)  27/151 (17.88%) 
Dyspnoea   36/153 (23.53%)  32/151 (21.19%) 
Hypoxia   30/153 (19.61%)  30/151 (19.87%) 
Pleural Effusion   26/153 (16.99%)  29/151 (19.21%) 
Oropharyngeal Pain   28/153 (18.30%)  16/151 (10.60%) 
Pulmonary Oedema   12/153 (7.84%)  14/151 (9.27%) 
Rales   12/153 (7.84%)  10/151 (6.62%) 
Haemoptysis   12/153 (7.84%)  7/151 (4.64%) 
Wheezing   11/153 (7.19%)  7/151 (4.64%) 
Hiccups   7/153 (4.58%)  9/151 (5.96%) 
Tachypnoea   7/153 (4.58%)  8/151 (5.30%) 
Nasal Congestion   9/153 (5.88%)  4/151 (2.65%) 
Skin and subcutaneous tissue disorders     
Rash   44/153 (28.76%)  33/151 (21.85%) 
Petechiae   21/153 (13.73%)  18/151 (11.92%) 
Pruritus   23/153 (15.03%)  13/151 (8.61%) 
Rash Maculo-Papular   14/153 (9.15%)  13/151 (8.61%) 
Erythema   14/153 (9.15%)  10/151 (6.62%) 
Hyperhidrosis   10/153 (6.54%)  13/151 (8.61%) 
Night Sweats   14/153 (9.15%)  8/151 (5.30%) 
Alopecia   4/153 (2.61%)  17/151 (11.26%) 
Blood Blister   14/153 (9.15%)  5/151 (3.31%) 
Rash Pruritic   10/153 (6.54%)  6/151 (3.97%) 
Dry Skin   8/153 (5.23%)  7/151 (4.64%) 
Rash Erythematous   6/153 (3.92%)  8/151 (5.30%) 
Skin Lesion   4/153 (2.61%)  9/151 (5.96%) 
Ecchymosis   9/153 (5.88%)  12/151 (7.95%) 
Vascular disorders     
Hypotension   30/153 (19.61%)  30/151 (19.87%) 
Hypertension   29/153 (18.95%)  23/151 (15.23%) 
Deep Vein Thrombosis   8/153 (5.23%)  9/151 (5.96%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Associate Director, Clinical Trial Disclosure & Transparency
Organization: Jazz Pharmaceuticals
Phone: 2158709177
EMail: tom.chmielewski@jazzpharma.com
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Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01696084    
Other Study ID Numbers: CLTR0310-301
First Submitted: September 26, 2012
First Posted: September 28, 2012
Results First Submitted: September 3, 2017
Results First Posted: October 2, 2017
Last Update Posted: August 10, 2020