Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH)

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: NCT01179737
Recruitment Status : Terminated (Study was terminated due to serious adverse event (SAE))
First Posted : August 11, 2010
Results First Posted : February 27, 2014
Last Update Posted : May 1, 2014
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Pulmonary Arterial Hypertension
Interventions Drug: Nilotinib
Drug: Placebo to nilotinib
Enrollment 23
Recruitment Details 23 participants were enrolled into the study (15 in cohort 1; 8 in cohort 2) 8 participants completed cohort 1 and 6 of these participants moved into cohort 1expansion. Of the 5 participants that completed Cohort 1 expansion; 3 participants went into an Extension. None of the participants completed treatment as trial was terminated
Pre-assignment Details Participants were randomized 6:1 ratio to nilotinib and placebo
Arm/Group Title Cohort 1: Nilotinib Cohort 1: Placebo Cohort 2: Nilotinib Cohort 2: Placebo
Hide Arm/Group Description Participants were assigned to receive nilotinib 50 mg during 14 days, followed by 150 mg during 14 days, followed by 300 mg during 140 days. Participants were assigned to receive placebo to nilotinib to match 50 mg and 150 mg capsules during 168 days. Participants were assigned to receive nilotinib 300 mg during 168 days Participants were assigned to receive placebo to match 50mg and / or 150mg capsules during 168 days
Period Title: Cohort 1 & Cohort 2
Started 12 3 [1] 4 4
Completed 7 1 0 0
Not Completed 5 2 4 4
Reason Not Completed
Adverse Event             3             1             1             0
Withdrew consent             2             0             0             0
Administrative problems             0             0             2             4
Death             0             0             1             0
Withdrew consent without EOS 1 visit             0             1             0             0
[1]
One patient was missing the end of study evaluation
Period Title: Cohort 1 & Cohort 2 Expansion
Started 5 [1] 1 0 0
Completed 4 1 0 0
Not Completed 1 0 0 0
Reason Not Completed
Death             1             0             0             0
[1]
2 participants did not enroll in extension
Period Title: Extension
Started 3 [1] 0 [2] 0 0
Completed 0 0 0 0
Not Completed 3 0 0 0
Reason Not Completed
The study was terminated             3             0             0             0
[1]
Two patients did not enrol in the extension
[2]
One patient did not enrol in the extension
Arm/Group Title Cohort 1: Nilotinib Cohort 1: Placebo Cohort 2: Nilotinib Cohort 2: Placebo Total
Hide Arm/Group Description Participants were assigned to receive nilotinib 50 mg during 14 days, followed by 150 mg during 14 days, followed by 300 mg during 140 days. Participants were assigned to receive placebo to nilotinib to match 50 mg and 150 mg capsules during 168 days. Participants were assigned to receive nilotinib 300 mg during 168 days Participants were assigned to receive placebo to match 50mg and / or 150mg capsules during 168 days Total of all reporting groups
Overall Number of Baseline Participants 12 3 4 4 23
Hide Baseline Analysis Population Description
an end of study evaluation was only available for 14 of these patients
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 3 participants 4 participants 4 participants 23 participants
52  (13.1) 60  (6.1) 31  (14.6) 33  (10.2) 32  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 3 participants 4 participants 4 participants 23 participants
Female
10
  83.3%
3
 100.0%
4
 100.0%
3
  75.0%
20
  87.0%
Male
2
  16.7%
0
   0.0%
0
   0.0%
1
  25.0%
3
  13.0%
1.Primary Outcome
Title Change in Pulmonary Vascular Resistance (PVR)
Hide Description Change in pulmonary vascular resistance is measured via right heart catheter assessment according to local hospital procedures. It assesses several prognostic hemodynamic variables in pulmonary hypertension, including Pulmonary Vascular Resistance (PVR). Study was prematurely terminated and not powered for efficacy.
Time Frame 168 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Change in Pulmonary Vascular Resistance (PVR)
Hide Arm/Group Description:

Change in pulmonary vascular resistance is measured via right heart catheter assessment according to local hospital procedures. It assesses several prognostic hemodynamic variables in pulmonary hypertension, including Pulmonary Vascular Resistance (PVR).

Additional information about the outcome measure, if needed for clarification. Outcome Measures are: Specific key measurement(s) or observation(s) used to measure the effect of experimental variables in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment.

Examples:

Title: all cause mortality Time Frame: one year Safety Issue: No

Title: Evidence of clinically definite ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI Time Frame: within the first 30 days (plus or minus 3 days) after surgery Safety Issue: Yes

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change in Six-Minute Walk Distance (6MWD) From Baseline
Hide Description During standardized walk course participants are connected to a portable pulse oximeter via a finger probe and instructed to walk at a comfortable speed for as far as they could manage in 6 minutes. Study was prematurely terminated and efficacy data were not analyzed or summarized
Time Frame Baseline, 168 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Change in Six-Minute Walk Distance (6MWD) From Baseline
Hide Arm/Group Description:
During standardized walk course participants are connected to a portable pulse oximeter via a finger probe and instructed to walk at a comfortable speed for as far as they could manage in 6 minu
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Total Number of Adverse Events and Serious Adverse Events
Hide Description Adverse events were summarized by the number of patients having any adverse event overall and presented in the safety section. Study was prematurely terminated.
Time Frame 168 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Number of Adverse Events and Serious Adverse Events
Hide Arm/Group Description:
Adverse events were summarized by the number of patients having any adverse event overall and presented in the safety section.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events were collected over the duration of treatment 140 days for cohort 1, 168 days for cohort 2 and up to 1092 days in the extension study
Adverse Event Reporting Description 23 participants were enrolled into the study; 8 participants completed cohort 1 and 6 of these participants moved into cohort 1 expansion of which 5 participants completed Cohort 1 expansion. Of the 5 participants, 3 went into an Extension. None of the participants completed treatment as trial was terminated
 
Arm/Group Title Cohort 1: Nilotinib Cohort 1: Placebo Cohort 2: Nilotinib Cohort 2: Placebo
Hide Arm/Group Description Participants were assigned to receive nilotinib 50 mg during 14 days, followed by 150 mg during 14 days, followed by 300 mg during 140 days. Participants were assigned to receive placebo to nilotinib to match 50 mg and 150 mg capsules during 168 days. Participants were assigned to receive nilotinib 300 mg during 168 days Participants were assigned to receive placebo to match 50mg and / or 150mg capsules during 168 days
All-Cause Mortality
Cohort 1: Nilotinib Cohort 1: Placebo Cohort 2: Nilotinib Cohort 2: Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1: Nilotinib Cohort 1: Placebo Cohort 2: Nilotinib Cohort 2: Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/12 (58.33%)   1/3 (33.33%)   2/4 (50.00%)   1/4 (25.00%) 
Blood and lymphatic system disorders         
Disseminated intravascular coagulation  1  0/12 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Cardiac disorders         
Cardiogenic shock  1  0/12 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Pulseless electrical activity  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Right ventricular dysfunction  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Torsade de pointes  1  0/12 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Gastrointestinal disorders         
Abdominal pain  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Gastric ulcer haemorrhage  1  0/12 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
General disorders         
Chest pain  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Device leakage  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Oedema peripheral  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Hepatobiliary disorders         
Cholecystitis acute  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Cholecystitis chronic  1  3/12 (25.00%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Cholelithiasis  1  2/12 (16.67%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Chronic hepatitis  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Infections and infestations         
Bronchitis  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Cellulitis  1  0/12 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Clostridial infection  1  0/12 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/4 (0.00%) 
Infusion site infection  1  0/12 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/4 (0.00%) 
Lobar pneumonia  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Sepsis  1  0/12 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/4 (0.00%) 
Musculoskeletal and connective tissue disorders         
Pathological fracture  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Systemic lupus erythematosus  1  0/12 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Hepatic neoplasm malignant  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Metastases to bone  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Renal and urinary disorders         
Renal failure acute  1  0/12 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Acute respiratory failure  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Dyspnoea  1  1/12 (8.33%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Haemothorax  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Productive cough  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Pulmonary arterial hypertension  1  3/12 (25.00%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Pulmonary oedema  1  0/12 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Vascular disorders         
Thrombophlebitis superficial  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1: Nilotinib Cohort 1: Placebo Cohort 2: Nilotinib Cohort 2: Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/12 (100.00%)   1/3 (33.33%)   3/4 (75.00%)   4/4 (100.00%) 
Blood and lymphatic system disorders         
Anaemia  1  3/12 (25.00%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Bone marrow oedema  1  0/12 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
Pancytopenia  1  1/12 (8.33%)  1/3 (33.33%)  0/4 (0.00%)  0/4 (0.00%) 
Polychromasia  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Red blood cell abnormality  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Cardiac disorders         
Dilatation ventricular  1  2/12 (16.67%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Left atrial dilatation  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Palpitations  1  2/12 (16.67%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Pericardial effusion  1  2/12 (16.67%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Right ventricular failure  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Right ventricular hypertrophy  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Sinus arrest  1  0/12 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Tricuspid valve incompetence  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Ventricular extrasystoles  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
Ventricular tachycardia  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Ear and labyrinth disorders         
Tinnitus  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Eye disorders         
Conjunctival hyperaemia  1  0/12 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Eye pain  1  0/12 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Periorbital oedema  1  0/12 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Gastrointestinal disorders         
Abdominal discomfort  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Abdominal distension  1  2/12 (16.67%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Abdominal pain  1  0/12 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
Abdominal pain upper  1  1/12 (8.33%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Constipation  1  3/12 (25.00%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Diarrhoea  1  4/12 (33.33%)  1/3 (33.33%)  1/4 (25.00%)  0/4 (0.00%) 
Dry mouth  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Flatulence  1  0/12 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
Gastrooesophageal reflux disease  1  2/12 (16.67%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Haemorrhoidal haemorrhage  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Hypoaesthesia oral  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Mucous stools  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Nausea  1  3/12 (25.00%)  1/3 (33.33%)  3/4 (75.00%)  1/4 (25.00%) 
Vomiting  1  3/12 (25.00%)  0/3 (0.00%)  3/4 (75.00%)  0/4 (0.00%) 
General disorders         
Application site irritation  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Asthenia  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Catheter site inflammation  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Chest discomfort  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Chest pain  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Chills  1  2/12 (16.67%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Fatigue  1  6/12 (50.00%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Injection site pain  1  0/12 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
Non-cardiac chest pain  1  0/12 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
Oedema  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Oedema peripheral  1  0/12 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  1/4 (25.00%) 
Pain  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Pyrexia  1  2/12 (16.67%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Infections and infestations         
Candidiasis  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Device related infection  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Nasopharyngitis  1  3/12 (25.00%)  0/3 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
Respiratory tract infection  1  0/12 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Upper respiratory tract infection  1  1/12 (8.33%)  1/3 (33.33%)  0/4 (0.00%)  1/4 (25.00%) 
Urinary tract infection  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
Urinary tract infection fungal  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Viral sinusitis  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Viral upper respiratory tract infection  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Vulvovaginal mycotic infection  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Wound infection staphylococcal  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Injury, poisoning and procedural complications         
Arthropod sting  1  0/12 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
Contusion  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Fall  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Investigations         
Alanine aminotransferase increased  1  1/12 (8.33%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Amylase increased  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Aspartate aminotransferase increased  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Biopsy bone  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Blood bilirubin increased  1  0/12 (0.00%)  0/3 (0.00%)  2/4 (50.00%)  0/4 (0.00%) 
Blood calcium decreased  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Blood potassium decreased  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Blood triglycerides increased  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Blood uric acid increased  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
C-reactive protein increased  1  0/12 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
Electrocardiogram T wave inversion  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Eosinophil count increased  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Haematocrit decreased  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Haemoglobin decreased  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Heart rate increased  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Lipase increased  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
Liver function test abnormal  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Lymphocyte count decreased  1  1/12 (8.33%)  1/3 (33.33%)  0/4 (0.00%)  0/4 (0.00%) 
Neutrophil count decreased  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Platelet count decreased  1  1/12 (8.33%)  1/3 (33.33%)  0/4 (0.00%)  0/4 (0.00%) 
Platelet count increased  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Red blood cell burr cells present  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Red blood cell count decreased  1  2/12 (16.67%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Right ventricular systolic pressure increased  1  2/12 (16.67%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Weight decreased  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
White blood cell count decreased  1  1/12 (8.33%)  1/3 (33.33%)  0/4 (0.00%)  0/4 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite  1  3/12 (25.00%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Fluid retention  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Hyperglycaemia  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Hypocalcaemia  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Hypoglycaemia  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Hypokalaemia  1  2/12 (16.67%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/12 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/4 (0.00%) 
Back pain  1  2/12 (16.67%)  0/3 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
Muscle spasms  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Musculoskeletal chest pain  1  0/12 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/4 (0.00%) 
Musculoskeletal pain  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Musculoskeletal stiffness  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Myalgia  1  0/12 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Pain in extremity  1  3/12 (25.00%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Lung neoplasm  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Thyroid neoplasm  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Nervous system disorders         
Carpal tunnel syndrome  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Convulsion  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Dizziness  1  0/12 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Dysgeusia  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Headache  1  6/12 (50.00%)  1/3 (33.33%)  3/4 (75.00%)  1/4 (25.00%) 
Migraine  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Presyncope  1  0/12 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Syncope  1  0/12 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  2/4 (50.00%) 
Psychiatric disorders         
Decreased interest  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Depression  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Insomnia  1  2/12 (16.67%)  0/3 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
Renal and urinary disorders         
Renal failure acute  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Urinary incontinence  1  0/12 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Reproductive system and breast disorders         
Gynaecomastia  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Pelvic pain  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Vaginal haemorrhage  1  0/12 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  4/12 (33.33%)  0/3 (0.00%)  1/4 (25.00%)  1/4 (25.00%) 
Diaphragmalgia  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Dyspnoea  1  2/12 (16.67%)  0/3 (0.00%)  1/4 (25.00%)  1/4 (25.00%) 
Epistaxis  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Nasal congestion  1  3/12 (25.00%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Oropharyngeal pain  1  2/12 (16.67%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Productive cough  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Pulmonary arterial hypertension  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Pulmonary oedema  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Rhinorrhoea  1  2/12 (16.67%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Sinus congestion  1  0/12 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/4 (0.00%) 
Skin and subcutaneous tissue disorders         
Alopecia  1  2/12 (16.67%)  0/3 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
Night sweats  1  0/12 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
Onychalgia  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Pain of skin  1  3/12 (25.00%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Pruritus  1  3/12 (25.00%)  0/3 (0.00%)  1/4 (25.00%)  1/4 (25.00%) 
Rash  1  3/12 (25.00%)  0/3 (0.00%)  2/4 (50.00%)  0/4 (0.00%) 
Rash macular  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Skin tightness  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Skin ulcer  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Vascular disorders         
Blood pressure fluctuation  1  0/12 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
Flushing  1  1/12 (8.33%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Hypotension  1  1/12 (8.33%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Inferior vena cava dilatation  1  2/12 (16.67%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharnaceuticals
Phone: 862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01179737     History of Changes
Obsolete Identifiers: NCT01531270
Other Study ID Numbers: CAMN107X2201
2010-019883-36 ( EudraCT Number )
First Submitted: August 3, 2010
First Posted: August 11, 2010
Results First Submitted: January 14, 2014
Results First Posted: February 27, 2014
Last Update Posted: May 1, 2014