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Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH) (IMPRES Extn)

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: NCT01117987
Recruitment Status : Terminated (Novartis discontinued the development of imatinib in PAH due to requirement of regulatory authorities for additional data to secure marketing approval in PAH.)
First Posted : May 6, 2010
Results First Posted : May 21, 2015
Last Update Posted : August 13, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pulmonary Arterial Hypertension
Interventions Drug: Imatinib
Drug: Placebo
Enrollment 144
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Core Imatinib Core Placebo
Hide Arm/Group Description Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated. Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
Period Title: Overall Study
Started 66 78
Completed 5 4
Not Completed 61 74
Reason Not Completed
Protocol deviation             0             1
Subject no longer requires study drug             1             0
Lost to Follow-up             1             1
Abnormal test procedure result             2             0
Lack of Efficacy             3             4
Death             5             10
Withdrawal by Subject             5             10
Adverse Event             19             26
Administrative problems             25             22
Arm/Group Title Core Imatinib Core Placebo Total
Hide Arm/Group Description Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated. Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated. Total of all reporting groups
Overall Number of Baseline Participants 66 78 144
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 66 participants 78 participants 144 participants
49.3  (15.52) 45.7  (13.31) 47.4  (14.42)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 78 participants 144 participants
Female
57
  86.4%
63
  80.8%
120
  83.3%
Male
9
  13.6%
15
  19.2%
24
  16.7%
1.Primary Outcome
Title Number of Participants With Adverse Events, Serious Adverse Events and Deaths
Hide Description Adverse event monitoring was conducted throughout the study.
Time Frame 204 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set: The safety set included all paticipants who received at least one dose of study drug during the extension.
Arm/Group Title Core Imatinib Core Placebo
Hide Arm/Group Description:
Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
Overall Number of Participants Analyzed 66 78
Measure Type: Number
Unit of Measure: Participants
Adverse events (non-serious and serious) 62 76
Serious adverse events 40 53
Deaths 6 10
2.Secondary Outcome
Title Change From Core Study Baseline in Six-Minute Walk Distance (6MWD)
Hide Description A six minute walk test (6MWT) was performed in accordance with the guidleines of the American Thoracic Society (2002).
Time Frame core study baseline, extension baseline, 12 weeks, 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 156 weeks, 204 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Full Analysis Set (FAS), who had values at both core study baseline and the given post-baseline time point, were included in the analysis for that post-baseline time point. The FAS included all participants who received at least one dose of study drug during the extension.
Arm/Group Title Core Imatinib Core Placebo
Hide Arm/Group Description:
Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
Overall Number of Participants Analyzed 66 78
Mean (Standard Deviation)
Unit of Measure: meters
Extension baseline (n=61,77) 42.98  (55.209) 4.91  (62.629)
Week 12 (n=58,57) 48.75  (60.887) 16.25  (64.992)
Week 24 (n=54,53) 44.71  (45.506) 19.34  (71.675)
Week 48 (n=47,42) 45.81  (72.150) 29.18  (65.198)
Week 72 (n=40,39) 49.54  (76.019) 56.46  (111.130)
Week 96 (n=38,35) 66.64  (71.080) 41.03  (54.495)
Week 120 (n=32,29) 83.19  (67.855) 37.43  (60.087)
Week 144 (n=27,21) 67.70  (64.000) 39.45  (79.356)
Week 156 (n=21,18) 72.60  (67.972) 30.17  (66.856)
Week 204 (n=4,3) 96.88  (42.048) 4.50  (25.608)
3.Secondary Outcome
Title Percentage of Participants With Incidence of Clinical Worsening Events
Hide Description Clinical worsening events included death, overnight hospitalization for worsening of PAH, worsening of World Health Organization (WHO) functional class by at least one level (drop in WHO ), 15% decrease in the 6MWD as compared to baseline confirmed by two 6MWTs at two consecutive study visits (6MWD reduction), and drop in WHO & 6MWD reduction. Some participants have fulfilled more than one criterion. Therefore, the sum of individual components may be higher than the total number of participants with clinical worsening.
Time Frame 204 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): The full analysis set included all participants who received at least one dose of study drug during the extension.
Arm/Group Title Core Imatinib Core Placebo
Hide Arm/Group Description:
Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
Overall Number of Participants Analyzed 66 78
Measure Type: Number
Unit of Measure: Percentage of participants
Total participants with clinical worsening 50.0 46.2
Death (all deaths) 7.6 12.8
Hospitalization for worsening of PAH 33.3 28.2
Drop in WHO 24.2 19.2
6MWD reduction 12.1 19.2
Drop in WHO and 6MWD reduction 1.5 3.8
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Core Imatinib Core Placebo
Hide Arm/Group Description Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated. Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
All-Cause Mortality
Core Imatinib Core Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Core Imatinib Core Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   40/66 (60.61%)   53/78 (67.95%) 
Blood and lymphatic system disorders     
Agranulocytosis  1  0/66 (0.00%)  1/78 (1.28%) 
Anaemia  1  3/66 (4.55%)  2/78 (2.56%) 
Coagulopathy  1  2/66 (3.03%)  0/78 (0.00%) 
Febrile neutropenia  1  0/66 (0.00%)  1/78 (1.28%) 
Iron deficiency anaemia  1  1/66 (1.52%)  0/78 (0.00%) 
Leukopenia  1  0/66 (0.00%)  3/78 (3.85%) 
Neutropenia  1  0/66 (0.00%)  1/78 (1.28%) 
Thrombocytopenia  1  0/66 (0.00%)  1/78 (1.28%) 
Cardiac disorders     
Acute coronary syndrome  1  1/66 (1.52%)  0/78 (0.00%) 
Angina pectoris  1  0/66 (0.00%)  1/78 (1.28%) 
Atrial fibrillation  1  0/66 (0.00%)  1/78 (1.28%) 
Atrial flutter  1  1/66 (1.52%)  1/78 (1.28%) 
Atrial tachycardia  1  1/66 (1.52%)  0/78 (0.00%) 
Bradycardia  1  0/66 (0.00%)  1/78 (1.28%) 
Cardiac arrest  1  0/66 (0.00%)  1/78 (1.28%) 
Cardiac tamponade  1  0/66 (0.00%)  1/78 (1.28%) 
Cardio-respiratory arrest  1  0/66 (0.00%)  2/78 (2.56%) 
Cor pulmonale  1  0/66 (0.00%)  1/78 (1.28%) 
Myocardial ischaemia  1  1/66 (1.52%)  0/78 (0.00%) 
Pericardial effusion  1  1/66 (1.52%)  0/78 (0.00%) 
Right ventricular failure  1  5/66 (7.58%)  8/78 (10.26%) 
Supraventricular tachycardia  1  1/66 (1.52%)  0/78 (0.00%) 
Tachycardia  1  0/66 (0.00%)  1/78 (1.28%) 
Ear and labyrinth disorders     
Deafness  1  0/66 (0.00%)  1/78 (1.28%) 
Endocrine disorders     
Hyperthyroidism  1  1/66 (1.52%)  1/78 (1.28%) 
Eye disorders     
Astigmatism  1  1/66 (1.52%)  0/78 (0.00%) 
Cataract  1  1/66 (1.52%)  0/78 (0.00%) 
Corneal erosion  1  1/66 (1.52%)  0/78 (0.00%) 
Glaucoma  1  1/66 (1.52%)  0/78 (0.00%) 
Periorbital oedema  1  1/66 (1.52%)  1/78 (1.28%) 
Gastrointestinal disorders     
Abdominal adhesions  1  1/66 (1.52%)  0/78 (0.00%) 
Abdominal pain upper  1  0/66 (0.00%)  1/78 (1.28%) 
Colitis  1  1/66 (1.52%)  0/78 (0.00%) 
Colonic fistula  1  1/66 (1.52%)  0/78 (0.00%) 
Diarrhoea  1  2/66 (3.03%)  0/78 (0.00%) 
Gastritis  1  1/66 (1.52%)  1/78 (1.28%) 
Gastrointestinal haemorrhage  1  1/66 (1.52%)  1/78 (1.28%) 
Gastrointestinal inflammation  1  0/66 (0.00%)  1/78 (1.28%) 
Haematemesis  1  0/66 (0.00%)  1/78 (1.28%) 
Nausea  1  1/66 (1.52%)  3/78 (3.85%) 
Pancreatitis acute  1  1/66 (1.52%)  0/78 (0.00%) 
Small intestinal obstruction  1  1/66 (1.52%)  0/78 (0.00%) 
Vomiting  1  2/66 (3.03%)  2/78 (2.56%) 
General disorders     
Asthenia  1  1/66 (1.52%)  0/78 (0.00%) 
Brain death  1  0/66 (0.00%)  1/78 (1.28%) 
Chest pain  1  0/66 (0.00%)  1/78 (1.28%) 
Chills  1  0/66 (0.00%)  1/78 (1.28%) 
Device dislocation  1  0/66 (0.00%)  1/78 (1.28%) 
Device leakage  1  1/66 (1.52%)  0/78 (0.00%) 
Device malfunction  1  0/66 (0.00%)  1/78 (1.28%) 
Device occlusion  1  0/66 (0.00%)  1/78 (1.28%) 
Exercise tolerance decreased  1  0/66 (0.00%)  1/78 (1.28%) 
Medical device complication  1  1/66 (1.52%)  0/78 (0.00%) 
Non-cardiac chest pain  1  1/66 (1.52%)  1/78 (1.28%) 
Oedema peripheral  1  1/66 (1.52%)  0/78 (0.00%) 
Pyrexia  1  1/66 (1.52%)  3/78 (3.85%) 
Hepatobiliary disorders     
Cholecystitis  1  0/66 (0.00%)  2/78 (2.56%) 
Cholelithiasis  1  0/66 (0.00%)  1/78 (1.28%) 
Hepatitis  1  0/66 (0.00%)  1/78 (1.28%) 
Infections and infestations     
Bacteraemia  1  0/66 (0.00%)  1/78 (1.28%) 
Cellulitis  1  0/66 (0.00%)  1/78 (1.28%) 
Clostridium difficile infection  1  0/66 (0.00%)  1/78 (1.28%) 
Colonic abscess  1  1/66 (1.52%)  0/78 (0.00%) 
Device related infection  1  5/66 (7.58%)  3/78 (3.85%) 
Device related sepsis  1  0/66 (0.00%)  1/78 (1.28%) 
Diverticulitis  1  1/66 (1.52%)  0/78 (0.00%) 
Gastroenteritis  1  1/66 (1.52%)  0/78 (0.00%) 
Gastroenteritis viral  1  0/66 (0.00%)  1/78 (1.28%) 
Herpes zoster  1  0/66 (0.00%)  1/78 (1.28%) 
Influenza  1  1/66 (1.52%)  1/78 (1.28%) 
Lobar pneumonia  1  1/66 (1.52%)  0/78 (0.00%) 
Mastitis  1  1/66 (1.52%)  0/78 (0.00%) 
Mycobacterial infection  1  1/66 (1.52%)  0/78 (0.00%) 
Nasopharyngitis  1  0/66 (0.00%)  1/78 (1.28%) 
Pneumonia  1  3/66 (4.55%)  3/78 (3.85%) 
Pseudomembranous colitis  1  0/66 (0.00%)  1/78 (1.28%) 
Pyelonephritis  1  0/66 (0.00%)  1/78 (1.28%) 
Soft tissue infection  1  0/66 (0.00%)  1/78 (1.28%) 
Staphylococcal sepsis  1  0/66 (0.00%)  1/78 (1.28%) 
Upper respiratory tract infection  1  1/66 (1.52%)  1/78 (1.28%) 
Urinary tract infection  1  0/66 (0.00%)  1/78 (1.28%) 
Viral infection  1  0/66 (0.00%)  1/78 (1.28%) 
Injury, poisoning and procedural complications     
Bone contusion  1  1/66 (1.52%)  0/78 (0.00%) 
Complications of transplanted lung  1  1/66 (1.52%)  0/78 (0.00%) 
Femur fracture  1  1/66 (1.52%)  0/78 (0.00%) 
Foot fracture  1  1/66 (1.52%)  0/78 (0.00%) 
Ligament sprain  1  1/66 (1.52%)  0/78 (0.00%) 
Overdose  1  0/66 (0.00%)  1/78 (1.28%) 
Radius fracture  1  1/66 (1.52%)  0/78 (0.00%) 
Subdural haematoma  1  1/66 (1.52%)  3/78 (3.85%) 
Tendon rupture  1  1/66 (1.52%)  0/78 (0.00%) 
Thoracic vertebral fracture  1  1/66 (1.52%)  0/78 (0.00%) 
Toxicity to various agents  1  0/66 (0.00%)  1/78 (1.28%) 
Investigations     
Blood potassium increased  1  1/66 (1.52%)  0/78 (0.00%) 
Eosinophil percentage increased  1  0/66 (0.00%)  1/78 (1.28%) 
Haematocrit decreased  1  0/66 (0.00%)  1/78 (1.28%) 
Intraocular pressure increased  1  1/66 (1.52%)  0/78 (0.00%) 
N-terminal prohormone brain natriuretic peptide  1  1/66 (1.52%)  0/78 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  0/66 (0.00%)  1/78 (1.28%) 
Dehydration  1  1/66 (1.52%)  3/78 (3.85%) 
Electrolyte imbalance  1  1/66 (1.52%)  0/78 (0.00%) 
Fluid overload  1  0/66 (0.00%)  1/78 (1.28%) 
Fluid retention  1  0/66 (0.00%)  2/78 (2.56%) 
Gout  1  0/66 (0.00%)  1/78 (1.28%) 
Hyperkalaemia  1  1/66 (1.52%)  0/78 (0.00%) 
Hypokalaemia  1  0/66 (0.00%)  1/78 (1.28%) 
Hyponatraemia  1  1/66 (1.52%)  1/78 (1.28%) 
Hypovolaemia  1  1/66 (1.52%)  0/78 (0.00%) 
Metabolic acidosis  1  1/66 (1.52%)  0/78 (0.00%) 
Musculoskeletal and connective tissue disorders     
Bursitis  1  1/66 (1.52%)  0/78 (0.00%) 
Joint effusion  1  0/66 (0.00%)  1/78 (1.28%) 
Systemic sclerosis  1  0/66 (0.00%)  1/78 (1.28%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute myeloid leukaemia  1  1/66 (1.52%)  0/78 (0.00%) 
Breast cancer  1  0/66 (0.00%)  1/78 (1.28%) 
Uterine leiomyoma  1  0/66 (0.00%)  1/78 (1.28%) 
Nervous system disorders     
Cerebral haemorrhage  1  1/66 (1.52%)  1/78 (1.28%) 
Cerebral infarction  1  1/66 (1.52%)  0/78 (0.00%) 
Convulsion  1  1/66 (1.52%)  1/78 (1.28%) 
Presyncope  1  1/66 (1.52%)  2/78 (2.56%) 
Syncope  1  2/66 (3.03%)  7/78 (8.97%) 
Transient ischaemic attack  1  1/66 (1.52%)  0/78 (0.00%) 
Psychiatric disorders     
Bipolar disorder  1  1/66 (1.52%)  0/78 (0.00%) 
Confusional state  1  0/66 (0.00%)  1/78 (1.28%) 
Renal and urinary disorders     
Lupus nephritis  1  0/66 (0.00%)  1/78 (1.28%) 
Nephrolithiasis  1  0/66 (0.00%)  1/78 (1.28%) 
Nephrotic syndrome  1  0/66 (0.00%)  1/78 (1.28%) 
Renal failure  1  0/66 (0.00%)  2/78 (2.56%) 
Renal failure acute  1  2/66 (3.03%)  2/78 (2.56%) 
Renal impairment  1  0/66 (0.00%)  1/78 (1.28%) 
Reproductive system and breast disorders     
Dysfunctional uterine bleeding  1  1/66 (1.52%)  0/78 (0.00%) 
Ovarian cyst ruptured  1  1/66 (1.52%)  0/78 (0.00%) 
Vaginal haemorrhage  1  0/66 (0.00%)  1/78 (1.28%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  0/66 (0.00%)  1/78 (1.28%) 
Apnoeic attack  1  1/66 (1.52%)  0/78 (0.00%) 
Asthma  1  0/66 (0.00%)  1/78 (1.28%) 
Atelectasis  1  1/66 (1.52%)  0/78 (0.00%) 
Dyspnoea  1  4/66 (6.06%)  5/78 (6.41%) 
Epistaxis  1  1/66 (1.52%)  0/78 (0.00%) 
Haemoptysis  1  3/66 (4.55%)  1/78 (1.28%) 
Hypoxia  1  0/66 (0.00%)  1/78 (1.28%) 
Interstitial lung disease  1  0/66 (0.00%)  2/78 (2.56%) 
Organising pneumonia  1  1/66 (1.52%)  0/78 (0.00%) 
Pleural effusion  1  1/66 (1.52%)  0/78 (0.00%) 
Pneumonia aspiration  1  1/66 (1.52%)  0/78 (0.00%) 
Pneumothorax  1  1/66 (1.52%)  1/78 (1.28%) 
Pulmonary arterial hypertension  1  6/66 (9.09%)  8/78 (10.26%) 
Pulmonary embolism  1  0/66 (0.00%)  2/78 (2.56%) 
Pulmonary hypertension  1  1/66 (1.52%)  0/78 (0.00%) 
Respiratory failure  1  3/66 (4.55%)  2/78 (2.56%) 
Skin and subcutaneous tissue disorders     
Drug eruption  1  0/66 (0.00%)  2/78 (2.56%) 
Eczema  1  0/66 (0.00%)  1/78 (1.28%) 
Scleroedema  1  1/66 (1.52%)  0/78 (0.00%) 
Telangiectasia  1  0/66 (0.00%)  1/78 (1.28%) 
Surgical and medical procedures     
Craniotomy  1  0/66 (0.00%)  1/78 (1.28%) 
Vascular disorders     
Arteriovenous fistula  1  0/66 (0.00%)  1/78 (1.28%) 
Haematoma  1  1/66 (1.52%)  1/78 (1.28%) 
Hypertensive crisis  1  0/66 (0.00%)  1/78 (1.28%) 
Hypotension  1  2/66 (3.03%)  1/78 (1.28%) 
Thrombosis  1  0/66 (0.00%)  1/78 (1.28%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Core Imatinib Core Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   55/66 (83.33%)   72/78 (92.31%) 
Blood and lymphatic system disorders     
Anaemia  1  5/66 (7.58%)  8/78 (10.26%) 
Iron deficiency anaemia  1  5/66 (7.58%)  6/78 (7.69%) 
Leukopenia  1  1/66 (1.52%)  9/78 (11.54%) 
Thrombocytopenia  1  6/66 (9.09%)  7/78 (8.97%) 
Cardiac disorders     
Palpitations  1  4/66 (6.06%)  4/78 (5.13%) 
Pericardial effusion  1  0/66 (0.00%)  4/78 (5.13%) 
Tachycardia  1  4/66 (6.06%)  4/78 (5.13%) 
Eye disorders     
Conjunctival haemorrhage  1  2/66 (3.03%)  5/78 (6.41%) 
Periorbital oedema  1  11/66 (16.67%)  23/78 (29.49%) 
Gastrointestinal disorders     
Abdominal discomfort  1  2/66 (3.03%)  5/78 (6.41%) 
Abdominal distension  1  4/66 (6.06%)  3/78 (3.85%) 
Abdominal pain  1  6/66 (9.09%)  5/78 (6.41%) 
Abdominal pain upper  1  2/66 (3.03%)  5/78 (6.41%) 
Constipation  1  3/66 (4.55%)  5/78 (6.41%) 
Diarrhoea  1  18/66 (27.27%)  27/78 (34.62%) 
Dyspepsia  1  3/66 (4.55%)  4/78 (5.13%) 
Gastritis  1  0/66 (0.00%)  4/78 (5.13%) 
Nausea  1  21/66 (31.82%)  39/78 (50.00%) 
Vomiting  1  14/66 (21.21%)  25/78 (32.05%) 
General disorders     
Asthenia  1  4/66 (6.06%)  2/78 (2.56%) 
Chest discomfort  1  2/66 (3.03%)  4/78 (5.13%) 
Face oedema  1  1/66 (1.52%)  4/78 (5.13%) 
Fatigue  1  9/66 (13.64%)  11/78 (14.10%) 
Non-cardiac chest pain  1  4/66 (6.06%)  4/78 (5.13%) 
Oedema peripheral  1  21/66 (31.82%)  32/78 (41.03%) 
Pyrexia  1  9/66 (13.64%)  5/78 (6.41%) 
Immune system disorders     
Seasonal allergy  1  3/66 (4.55%)  4/78 (5.13%) 
Infections and infestations     
Bronchitis  1  1/66 (1.52%)  8/78 (10.26%) 
Device related infection  1  0/66 (0.00%)  4/78 (5.13%) 
Influenza  1  5/66 (7.58%)  2/78 (2.56%) 
Nasopharyngitis  1  17/66 (25.76%)  24/78 (30.77%) 
Pneumonia  1  1/66 (1.52%)  4/78 (5.13%) 
Respiratory tract infection  1  3/66 (4.55%)  7/78 (8.97%) 
Upper respiratory tract infection  1  6/66 (9.09%)  11/78 (14.10%) 
Urinary tract infection  1  3/66 (4.55%)  8/78 (10.26%) 
Injury, poisoning and procedural complications     
Contusion  1  4/66 (6.06%)  1/78 (1.28%) 
Fall  1  4/66 (6.06%)  1/78 (1.28%) 
Ligament sprain  1  0/66 (0.00%)  4/78 (5.13%) 
Investigations     
Blood creatinine increased  1  4/66 (6.06%)  3/78 (3.85%) 
Weight decreased  1  5/66 (7.58%)  3/78 (3.85%) 
Weight increased  1  4/66 (6.06%)  4/78 (5.13%) 
Metabolism and nutrition disorders     
Decreased appetite  1  2/66 (3.03%)  4/78 (5.13%) 
Fluid overload  1  1/66 (1.52%)  4/78 (5.13%) 
Gout  1  2/66 (3.03%)  4/78 (5.13%) 
Hypokalaemia  1  5/66 (7.58%)  10/78 (12.82%) 
Vitamin B12 deficiency  1  5/66 (7.58%)  0/78 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  5/66 (7.58%)  12/78 (15.38%) 
Back pain  1  6/66 (9.09%)  4/78 (5.13%) 
Muscle spasms  1  8/66 (12.12%)  12/78 (15.38%) 
Musculoskeletal pain  1  4/66 (6.06%)  2/78 (2.56%) 
Myalgia  1  2/66 (3.03%)  4/78 (5.13%) 
Pain in extremity  1  6/66 (9.09%)  5/78 (6.41%) 
Nervous system disorders     
Dizziness  1  9/66 (13.64%)  5/78 (6.41%) 
Headache  1  12/66 (18.18%)  24/78 (30.77%) 
Psychiatric disorders     
Insomnia  1  2/66 (3.03%)  5/78 (6.41%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  16/66 (24.24%)  11/78 (14.10%) 
Dyspnoea  1  10/66 (15.15%)  6/78 (7.69%) 
Epistaxis  1  6/66 (9.09%)  6/78 (7.69%) 
Hypoxia  1  2/66 (3.03%)  4/78 (5.13%) 
Nasal congestion  1  5/66 (7.58%)  2/78 (2.56%) 
Oropharyngeal pain  1  8/66 (12.12%)  1/78 (1.28%) 
Pulmonary arterial hypertension  1  2/66 (3.03%)  4/78 (5.13%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  3/66 (4.55%)  4/78 (5.13%) 
Pruritus  1  1/66 (1.52%)  6/78 (7.69%) 
Rash  1  7/66 (10.61%)  13/78 (16.67%) 
Vascular disorders     
Flushing  1  2/66 (3.03%)  5/78 (6.41%) 
Hypotension  1  6/66 (9.09%)  3/78 (3.85%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Within primary outcome measure (OM) #1, an additional death (>30 days post study completion) was included in the imatinib arm. The participant flow and secondary OM #2 reflect deaths that occurred up to and including 30 days post study completion.
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
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: Trialandresults.registries@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01117987    
Other Study ID Numbers: CQTI571A2301E1
2009-018167-26
First Submitted: May 3, 2010
First Posted: May 6, 2010
Results First Submitted: April 2, 2015
Results First Posted: May 21, 2015
Last Update Posted: August 13, 2015