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Trial of CPX-351 in Newly Diagnosed Elderly AML Patients

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ClinicalTrials.gov Identifier: NCT00788892
Recruitment Status : Completed
First Posted : November 11, 2008
Results First Posted : January 12, 2018
Last Update Posted : January 12, 2018
Sponsor:
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 Acute Myeloid Leukemia
Interventions Drug: CPX-351
Drug: Cytarabine
Drug: Daunorubicin
Enrollment 126
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm A: CPX-351 Arm B: Cytarabine + Daunorubicin
Hide Arm/Group Description First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3 First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice
Period Title: Overall Study
Started 85 41
Completed 36 18
Not Completed 49 23
Arm/Group Title Arm A: CPX-351 Arm B: Cytarabine + Daunorubicin Total
Hide Arm/Group Description First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3 First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice Total of all reporting groups
Overall Number of Baseline Participants 85 41 126
Hide Baseline Analysis Population Description
Safety population: All randomized participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 85 participants 41 participants 126 participants
67.8  (4.63) 68.2  (4.88) 67.9  (4.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants 41 participants 126 participants
Female
32
  37.6%
16
  39.0%
48
  38.1%
Male
53
  62.4%
25
  61.0%
78
  61.9%
1.Primary Outcome
Title Number of Participants With Complete Remission
Hide Description Response was defined according to International Working Group Criteria (Cheson, et al. 2003) which requires peripheral blood neutrophils of >1000/µL and peripheral blood platelets of >100,000/µL in the absence of bone marrow blasts.
Time Frame Within 6 weeks of the last induction treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Analysis Set: All randomized subjects who received at least 1 dose of study drug. One subject who developed Philadelphia chromosome positive disease prior to any efficacy assessment was excluded from the Efficacy Analysis Set.
Arm/Group Title Arm A: CPX-351 Arm B: Cytarabine + Daunorubicin
Hide Arm/Group Description:
First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3
First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice
Overall Number of Participants Analyzed 84 41
Measure Type: Count of Participants
Unit of Measure: Participants
41
  48.8%
20
  48.8%
2.Secondary Outcome
Title Remission Duration/Time to Remission
Hide Description

Remission Duration was assessed from the time measurement criteria for CR were met until the first date that disease relapse was objectively documented or the subject died.

Time to remission was measured from the date of randomization to the time measurement criteria for CR were first met.

Time Frame Following achievement of CR over the study period
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Analysis Set
Arm/Group Title Arm A: CPX-351 Arm B: Cytarabine + Daunorubicin
Hide Arm/Group Description:
First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3
First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice
Overall Number of Participants Analyzed 84 41
Median (Full Range)
Unit of Measure: days
Remission Duration
275
(40 to 730)
235
(36 to 703)
Time to Remission
49
(32 to 163)
40
(21 to 89)
3.Secondary Outcome
Title Event Free Survival
Hide Description Event-free survival begins from randomization to the date persistent disease is documented or date of relapse after CR, or death, whichever comes first.
Time Frame Up to 1 year from randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Analysis Set
Arm/Group Title Arm A: CPX-351 Arm B: Cytarabine + Daunorubicin
Hide Arm/Group Description:
First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3
First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice
Overall Number of Participants Analyzed 84 41
Median (95% Confidence Interval)
Unit of Measure: days
161
(116 to 226)
55
(34 to 205)
4.Secondary Outcome
Title Overall Survival Rate at 1 Year
Hide Description Survival defined as the time from randomization to death.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Analysis Set
Arm/Group Title Arm A: CPX-351 Arm B: Cytarabine + Daunorubicin
Hide Arm/Group Description:
First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3
First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice
Overall Number of Participants Analyzed 84 41
Measure Type: Number
Unit of Measure: participants
39 18
5.Secondary Outcome
Title Rate of Stem Cell Transplant
Hide Description The rate of patients who underwent stem cell transplant.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Analysis Set
Arm/Group Title Arm A: CPX-351 Arm B: Cytarabine + Daunorubicin
Hide Arm/Group Description:
First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3
First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice
Overall Number of Participants Analyzed 84 41
Measure Type: Count of Participants
Unit of Measure: Participants
13
  15.5%
10
  24.4%
6.Secondary Outcome
Title Aplasia Rate
Hide Description Bone marrow aplasia was defined as <20% cellularity and 5% blasts in the bone marrow aspiration evaluation.
Time Frame Day 14 (1st Induction)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Analysis Set
Arm/Group Title Arm A: CPX-351 Arm B: Cytarabine + Daunorubicin
Hide Arm/Group Description:
First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3
First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice
Overall Number of Participants Analyzed 84 41
Measure Type: Count of Participants
Unit of Measure: Participants
55
  65.5%
15
  36.6%
Time Frame Assessed during treatment period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)
Adverse Event Reporting Description The Safety Analysis Set included subjects receiving at least 1 dose of study drug and consisted of 126 subjects.
 
Arm/Group Title Arm A: CPX-351 Arm B: Cytarabine + Daunorubicin
Hide Arm/Group Description First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3 First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice
All-Cause Mortality
Arm A: CPX-351 Arm B: Cytarabine + Daunorubicin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm A: CPX-351 Arm B: Cytarabine + Daunorubicin
Affected / at Risk (%) Affected / at Risk (%)
Total   47/85 (55.29%)   16/41 (39.02%) 
Blood and lymphatic system disorders     
Anaemia  1/85 (1.18%)  0/41 (0.00%) 
Febrile Neutropenia  9/85 (10.59%)  4/41 (9.76%) 
Thrombocytopenia  1/85 (1.18%)  1/41 (2.44%) 
Cardiac disorders     
Acute Myocardial Infarction  0/85 (0.00%)  1/41 (2.44%) 
Angina Pectoris  0/85 (0.00%)  1/41 (2.44%) 
Atrial Fibrillation  1/85 (1.18%)  0/41 (0.00%) 
Cardiac Arrest  0/85 (0.00%)  1/41 (2.44%) 
Cardiac Failure Congestive  1/85 (1.18%)  0/41 (0.00%) 
Myocardial Infarction  1/85 (1.18%)  2/41 (4.88%) 
Restrictive Cardiomyopathy  1/85 (1.18%)  0/41 (0.00%) 
Supraventricular Tachycardia  0/85 (0.00%)  1/41 (2.44%) 
Eye disorders     
Blindness  1/85 (1.18%)  0/41 (0.00%) 
Mouth Haemorrhage  1/85 (1.18%)  0/41 (0.00%) 
Gastrointestinal disorders     
Abdominal Pain  3/85 (3.53%)  0/41 (0.00%) 
Gastrointestinal Necrosis  0/85 (0.00%)  1/41 (2.44%) 
Ileal Perforation  1/85 (1.18%)  0/41 (0.00%) 
Nausea  1/85 (1.18%)  0/41 (0.00%) 
Small Intestinal Obstruction  1/85 (1.18%)  0/41 (0.00%) 
Vomiting  1/85 (1.18%)  0/41 (0.00%) 
General disorders     
Disease Progression  3/85 (3.53%)  0/41 (0.00%) 
Infusion Related Reaction  1/85 (1.18%)  0/41 (0.00%) 
Pain  1/85 (1.18%)  0/41 (0.00%) 
Pyrexia  7/85 (8.24%)  0/41 (0.00%) 
Hepatobiliary disorders     
Hyperbilirubinaemia  1/85 (1.18%)  0/41 (0.00%) 
Immune system disorders     
Graft Versus Host Disease  1/85 (1.18%)  0/41 (0.00%) 
Infections and infestations     
Bacteraemia  6/85 (7.06%)  1/41 (2.44%) 
Catheter Site Cellulitis  1/85 (1.18%)  0/41 (0.00%) 
Catheter Site Infection  1/85 (1.18%)  0/41 (0.00%) 
Cellulitis  1/85 (1.18%)  0/41 (0.00%) 
Clostridium Difficile Colitis  0/85 (0.00%)  1/41 (2.44%) 
Device Related Sepsis  1/85 (1.18%)  0/41 (0.00%) 
Fungal Infection  1/85 (1.18%)  0/41 (0.00%) 
Fungal Retinitis  1/85 (1.18%)  0/41 (0.00%) 
Fungal Skin Infection  1/85 (1.18%)  0/41 (0.00%) 
Pneumonia  4/85 (4.71%)  2/41 (4.88%) 
Pneumonia Fungal  2/85 (2.35%)  0/41 (0.00%) 
Sepsis  7/85 (8.24%)  2/41 (4.88%) 
Septic Shock  0/85 (0.00%)  1/41 (2.44%) 
System Mycosis  1/85 (1.18%)  0/41 (0.00%) 
Urinary Tract Infection  0/85 (0.00%)  1/41 (2.44%) 
Injury, poisoning and procedural complications     
Brain Herniation  1/85 (1.18%)  0/41 (0.00%) 
Hip Fracture  1/85 (1.18%)  0/41 (0.00%) 
Investigations     
Blood Creatinine Increased  1/85 (1.18%)  0/41 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute Myeloid Leukaemia  1/85 (1.18%)  0/41 (0.00%) 
Leukaemia Recurrent  0/85 (0.00%)  1/41 (2.44%) 
Malignant Melanoma In Situ  1/85 (1.18%)  0/41 (0.00%) 
Nervous system disorders     
Convulsion  1/85 (1.18%)  0/41 (0.00%) 
Haemorrhage Intracranial  1/85 (1.18%)  0/41 (0.00%) 
Subarachnoid Haemorrhage  1/85 (1.18%)  0/41 (0.00%) 
Syncope  1/85 (1.18%)  0/41 (0.00%) 
Psychiatric disorders     
Mental Status Changes  1/85 (1.18%)  0/41 (0.00%) 
Psychotic Disorder  0/85 (0.00%)  1/41 (2.44%) 
Renal and urinary disorders     
Nephrogenic Diabetes Insipidus  1/85 (1.18%)  0/41 (0.00%) 
Renal Failure  0/85 (0.00%)  1/41 (2.44%) 
Renal Failure Acute  3/85 (3.53%)  0/41 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute Respiratory Failure  1/85 (1.18%)  0/41 (0.00%) 
Dyspnoea  2/85 (2.35%)  1/41 (2.44%) 
Epistaxis  2/85 (2.35%)  0/41 (0.00%) 
Non-Cardiogenic Pulmonary Oedema  1/85 (1.18%)  0/41 (0.00%) 
Pulmonary Oedema  0/85 (0.00%)  1/41 (2.44%) 
Respiratory Arrest  0/85 (0.00%)  1/41 (2.44%) 
Respiratory Distress  1/85 (1.18%)  0/41 (0.00%) 
Respiratory Failure  2/85 (2.35%)  0/41 (0.00%) 
Respiratory Tract Haemorrhage  1/85 (1.18%)  0/41 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash  1/85 (1.18%)  0/41 (0.00%) 
Stevens-Johnson Syndrome  1/85 (1.18%)  0/41 (0.00%) 
Vascular disorders     
Hypotension  0/85 (0.00%)  1/41 (2.44%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A: CPX-351 Arm B: Cytarabine + Daunorubicin
Affected / at Risk (%) Affected / at Risk (%)
Total   85/85 (100.00%)   41/41 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  3/85 (3.53%)  3/41 (7.32%) 
Febrile Neutropenia  50/85 (58.82%)  19/41 (46.34%) 
Neutropenia  7/85 (8.24%)  6/41 (14.63%) 
Thrombocytopenia  7/85 (8.24%)  5/41 (12.20%) 
Increased tendency to bruise  5/85 (5.88%)  2/41 (4.88%) 
Cardiac disorders     
Angina Pectoris  2/85 (2.35%)  5/41 (12.20%) 
Atrial Fibrillation  12/85 (14.12%)  4/41 (9.76%) 
Bradycardia  8/85 (9.41%)  1/41 (2.44%) 
Tachycardia  11/85 (12.94%)  7/41 (17.07%) 
Eye disorders     
Conjunctivitis  5/85 (5.88%)  1/41 (2.44%) 
Gastrointestinal disorders     
Abdominal Distension  11/85 (12.94%)  6/41 (14.63%) 
Abdominal Pain  20/85 (23.53%)  6/41 (14.63%) 
Abdominal Pain Upper  10/85 (11.76%)  2/41 (4.88%) 
Ascites  3/85 (3.53%)  3/41 (7.32%) 
Constipation  43/85 (50.59%)  23/41 (56.10%) 
Diarrhoea  56/85 (65.88%)  27/41 (65.85%) 
Dry Mouth  9/85 (10.59%)  3/41 (7.32%) 
Dyspepsia  11/85 (12.94%)  5/41 (12.20%) 
Dysphagia  6/85 (7.06%)  2/41 (4.88%) 
Haemorrhoids  7/85 (8.24%)  5/41 (12.20%) 
Mouth Haemorrhage  10/85 (11.76%)  4/41 (9.76%) 
Mouth Ulceration  6/85 (7.06%)  1/41 (2.44%) 
Nausea  56/85 (65.88%)  22/41 (53.66%) 
Oral Disorder  6/85 (7.06%)  2/41 (4.88%) 
Oral Pain  6/85 (7.06%)  0/41 (0.00%) 
Stomatitis  30/85 (35.29%)  9/41 (21.95%) 
Toothache  5/85 (5.88%)  2/41 (4.88%) 
Vomiting  23/85 (27.06%)  12/41 (29.27%) 
Gingival bleeding  3/85 (3.53%)  3/41 (7.32%) 
Melaena  2/85 (2.35%)  4/41 (9.76%) 
Proctalgia  6/85 (7.06%)  0/41 (0.00%) 
General disorders     
Asthenia  13/85 (15.29%)  7/41 (17.07%) 
Catheter SIte Erythema  17/85 (20.00%)  6/41 (14.63%) 
Catheter Site Pain  9/85 (10.59%)  5/41 (12.20%) 
Chills  33/85 (38.82%)  13/41 (31.71%) 
Fatigue  35/85 (41.18%)  12/41 (29.27%) 
Gait Disturbance  5/85 (5.88%)  0/41 (0.00%) 
Oedema peripheral  44/85 (51.76%)  18/41 (43.90%) 
Oedema  6/85 (7.06%)  5/41 (12.20%) 
Pain  9/85 (10.59%)  3/41 (7.32%) 
Pyrexia  26/85 (30.59%)  14/41 (34.15%) 
Chest pain  7/85 (8.24%)  0/41 (0.00%) 
Hepatobiliary disorders     
Hyperbilirubinaemia  9/85 (10.59%)  3/41 (7.32%) 
Immune system disorders     
Drug Hypersensitivity  5/85 (5.88%)  1/41 (2.44%) 
Infections and infestations     
Bacteraemia  10/85 (11.76%)  2/41 (4.88%) 
Catheter Site Infection  5/85 (5.88%)  5/41 (12.20%) 
Cellulitis  6/85 (7.06%)  3/41 (7.32%) 
Clostridium difficile infection  9/85 (10.59%)  0/41 (0.00%) 
Pneumonia  15/85 (17.65%)  12/41 (29.27%) 
Bacterial disease carrier  5/85 (5.88%)  2/41 (4.88%) 
Enterococcal bacteraemia  5/85 (5.88%)  4/41 (9.76%) 
Staphylococcal bacteraemia  12/85 (14.12%)  1/41 (2.44%) 
Injury, poisoning and procedural complications     
Transfusion Reaction  10/85 (11.76%)  2/41 (4.88%) 
Investigations     
Blood Alkaline Phosphate Increased  5/85 (5.88%)  0/41 (0.00%) 
Blood Creatinine Increased  5/85 (5.88%)  4/41 (9.76%) 
Breath Sounds Abnormal  5/85 (5.88%)  0/41 (0.00%) 
Cardiac Murmur  8/85 (9.41%)  1/41 (2.44%) 
Weight Decreased  7/85 (8.24%)  5/41 (12.20%) 
Weight Increased  8/85 (9.41%)  2/41 (4.88%) 
Metabolism and nutrition disorders     
Decreased Appetite  34/85 (40.00%)  16/41 (39.02%) 
Dehydration  5/85 (5.88%)  1/41 (2.44%) 
Fluid Overload  5/85 (5.88%)  2/41 (4.88%) 
Hyperglycaemia  2/85 (2.35%)  4/41 (9.76%) 
Hypokalaemia  21/85 (24.71%)  14/41 (34.15%) 
Hypomagnesaemia  12/85 (14.12%)  2/41 (4.88%) 
Hyponatraemia  7/85 (8.24%)  1/41 (2.44%) 
Hypophosphataemia  8/85 (9.41%)  2/41 (4.88%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  12/85 (14.12%)  2/41 (4.88%) 
Muscular Weakness  4/85 (4.71%)  5/41 (12.20%) 
Myalgia  7/85 (8.24%)  1/41 (2.44%) 
Back pain  11/85 (12.94%)  4/41 (9.76%) 
Musculoskeletal pain  7/85 (8.24%)  2/41 (4.88%) 
Neck pain  5/85 (5.88%)  1/41 (2.44%) 
Pain in extremity  13/85 (15.29%)  4/41 (9.76%) 
Pain in jaw  1/85 (1.18%)  3/41 (7.32%) 
Nervous system disorders     
Dizziness  19/85 (22.35%)  12/41 (29.27%) 
Dysgeusia  6/85 (7.06%)  3/41 (7.32%) 
Headache  30/85 (35.29%)  8/41 (19.51%) 
Lethargy  6/85 (7.06%)  0/41 (0.00%) 
Somnolence  6/85 (7.06%)  0/41 (0.00%) 
Syncope  5/85 (5.88%)  2/41 (4.88%) 
Tremor  6/85 (7.06%)  1/41 (2.44%) 
Psychiatric disorders     
Anxiety  16/85 (18.82%)  7/41 (17.07%) 
Confusional State  12/85 (14.12%)  1/41 (2.44%) 
Depression  10/85 (11.76%)  2/41 (4.88%) 
Hallucination  11/85 (12.94%)  1/41 (2.44%) 
Insomnia  24/85 (28.24%)  5/41 (12.20%) 
Mental Status Change  5/85 (5.88%)  3/41 (7.32%) 
Renal and urinary disorders     
Haematuria  5/85 (5.88%)  2/41 (4.88%) 
Pollakiuria  2/85 (2.35%)  3/41 (7.32%) 
Renal Failure  3/85 (3.53%)  3/41 (7.32%) 
Renal Failure Acute  5/85 (5.88%)  2/41 (4.88%) 
Respiratory, thoracic and mediastinal disorders     
Atelectasis  6/85 (7.06%)  5/41 (12.20%) 
Cough  33/85 (38.82%)  5/41 (12.20%) 
Dysphonia  5/85 (5.88%)  1/41 (2.44%) 
Dyspnoea  18/85 (21.18%)  5/41 (12.20%) 
Dyspnoea Exertional  5/85 (5.88%)  1/41 (2.44%) 
Epistaxis  30/85 (35.29%)  8/41 (19.51%) 
Haemoptysis  6/85 (7.06%)  0/41 (0.00%) 
Hiccups  2/85 (2.35%)  3/41 (7.32%) 
Hypoxia  13/85 (15.29%)  4/41 (9.76%) 
Nasal Congestion  7/85 (8.24%)  1/41 (2.44%) 
Oropharyngeal Pain  14/85 (16.47%)  6/41 (14.63%) 
Pleural Effusion  15/85 (17.65%)  5/41 (12.20%) 
Pulmonary Hypertension  1/85 (1.18%)  3/41 (7.32%) 
Pulmonary Oedema  6/85 (7.06%)  2/41 (4.88%) 
Rales  10/85 (11.76%)  5/41 (12.20%) 
Tachypnoea  1/85 (1.18%)  4/41 (9.76%) 
Wheezing  5/85 (5.88%)  0/41 (0.00%) 
Skin and subcutaneous tissue disorders     
Alopecia  5/85 (5.88%)  9/41 (21.95%) 
Dry Skin  6/85 (7.06%)  2/41 (4.88%) 
Ecchymosis  8/85 (9.41%)  1/41 (2.44%) 
Erythema  10/85 (11.76%)  7/41 (17.07%) 
Hyperhidrosis  14/85 (16.47%)  0/41 (0.00%) 
Night Sweats  8/85 (9.41%)  3/41 (7.32%) 
Petechiae  28/85 (32.94%)  5/41 (12.20%) 
Pruritus  22/85 (25.88%)  6/41 (14.63%) 
Rash  45/85 (52.94%)  15/41 (36.59%) 
Skin Lesion  6/85 (7.06%)  1/41 (2.44%) 
Purpura  4/85 (4.71%)  3/41 (7.32%) 
Rash erythematous  8/85 (9.41%)  6/41 (14.63%) 
Rash maculo-papular  11/85 (12.94%)  1/41 (2.44%) 
Vascular disorders     
Hypertension  16/85 (18.82%)  6/41 (14.63%) 
Hypotension  15/85 (17.65%)  10/41 (24.39%) 
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
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Name/Title: Associate Director, Clinical Trial Disclosure & Transparency
Organization: Jazz Pharmaceuticals
Phone: 215-832-3750
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Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00788892     History of Changes
Other Study ID Numbers: CLTR0308-204
First Submitted: November 10, 2008
First Posted: November 11, 2008
Results First Submitted: September 3, 2017
Results First Posted: January 12, 2018
Last Update Posted: January 12, 2018