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Study to Assess Safety and Efficacy of Ticagrelor (AZD6140) Versus Clopidogrel in Asian/Japanese Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS)

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ClinicalTrials.gov Identifier: NCT01294462
Recruitment Status : Completed
First Posted : February 11, 2011
Results First Posted : May 2, 2014
Last Update Posted : June 27, 2014
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Acute Coronary Syndrome
Percutaneous Coronary Intervention
Interventions Drug: Ticagrelor
Drug: Clopidogrel
Drug: Acetylsalicylic acid ASA
Enrollment 801
Recruitment Details In total, 817 patients were enrolled from 3 countries (Japan, South Korea and Taiwan). Of the randomised patients, most patients were Japanese (723 [90.3%]). The first patient was enrolled on 28 February 2010 and the last patient completed the study on 31 July 2012.
Pre-assignment Details In total, 801 patients (401 in the ticagrelor [AZD6140 90 mg bd] group and 400 patients in the clopidogrel [clopidogrel 75 mg od] group) were randomised to treatment. The reasons for not being randomised were “Incorrect enrolment before randomisation” and “Patient decision (withdrawal of consent)”.
Arm/Group Title Ticagrelor (AZD6140) Clopidogrel
Hide Arm/Group Description Ticagrelor (AZD6140) 90 mg bid Clopidogrel 75mg od
Period Title: Overall Study
Started 401 400
Received Randomized Treatment 387 380
Completed 335 337
Not Completed 66 63
Reason Not Completed
Lost to Follow-up             1             0
Withdrawal by Subject             65             63
Arm/Group Title Ticagrelor (AZD6140) Clopidogrel Total
Hide Arm/Group Description Ticagrelor (AZD6140) 90 mg bid Clopidogrel 75mg od Total of all reporting groups
Overall Number of Baseline Participants 400 400 800
Hide Baseline Analysis Population Description
One discontinued patient (due to withdrawal of consent) in Ticagrelor (AZD6140) group did not agree to disclose any data. Thus the number of baseline participants in Ticagrelor (AZD6140) group is 400 instead of 401 that is the number of participants who started the first period.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 400 participants 400 participants 800 participants
67  (12) 66  (11) 67  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 400 participants 400 participants 800 participants
Female
95
  23.8%
93
  23.3%
188
  23.5%
Male
305
  76.3%
307
  76.8%
612
  76.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 400 participants 400 participants 800 participants
Chinese 16 19 35
Japanese 361 360 721
Korean 23 21 44
1.Primary Outcome
Title Major Bleeding
Hide Description Time to first occurrence of any major bleeding event (adjudicated by an independent Clinical Endpoint Committee (ICEC)). 1-year event rate (%) estimated via Kaplan-Meier method.
Time Frame Ongoing up to12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set which includes all patients who received randomized treatment with available post-treatment safety data
Arm/Group Title Ticagrelor (AZD6140) Clopidogrel
Hide Arm/Group Description:
Ticagrelor (AZD6140) 90mg bid
Clopidogrel 75mg od
Overall Number of Participants Analyzed 387 380
Measure Type: Number
Unit of Measure: Percent probability
11.2 8.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ticagrelor (AZD6140), Clopidogrel
Comments No formal statistical comparison.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments No P-value provided since the objective was not to perform formal statistical comparison.
Method Regression, Cox
Comments Analyzed based on proportional hazards model including treatment group only.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.54
Confidence Interval (2-Sided) 95%
0.94 to 2.53
Estimation Comments Ticagrelor/Placebo
2.Primary Outcome
Title Major Adverse Cardiac Events (MACE)
Hide Description Time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke (adjudicated by an ICEC). 1-year event rate (%) estimated via Kaplan-Meier method.
Time Frame Ongoing up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set which includes all randomized patients with available post-randomization efficacy data
Arm/Group Title Ticagrelor (AZD6140) Clopidogrel
Hide Arm/Group Description:
Ticagrelor (AZD6140) 90mg bid
Clopidogrel 75mg od
Overall Number of Participants Analyzed 400 400
Measure Type: Number
Unit of Measure: Percent probability
10.2 8.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ticagrelor (AZD6140), Clopidogrel
Comments No formal statistical comparison based on hypothesis test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments No P-value provided since the objective was not to perform formal statistical comparison.
Method Regression, Cox
Comments Analyzed based on proportional hazards model including treatment group only.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.47
Confidence Interval (2-Sided) 95%
0.88 to 2.44
Estimation Comments Ticagrelor/Placebo
3.Secondary Outcome
Title Major and Minor Bleeding
Hide Description Time to first occurrence of any major or minor bleeding event (adjudicated by an independent Clinical Endpoint Committee (ICEC)). 1-year event rate (%) estimated via Kaplan-Meier method.
Time Frame Ongoing up to12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set which includes all patients who received randomized treatment with available post-treatment safety data
Arm/Group Title Ticagrelor (AZD6140) Clopidogrel
Hide Arm/Group Description:
Ticagrelor (AZD6140) 90mg bid
Clopidogrel 75mg od
Overall Number of Participants Analyzed 387 380
Measure Type: Number
Unit of Measure: Percent probability
26.8 16.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ticagrelor (AZD6140), Clopidogrel
Comments No formal statistical comparison.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments No P-value provided since the objective was not to perform formal statistical comparison.
Method Regression, Cox
Comments Analyzed based on proportional hazards model including treatment group only.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.72
Confidence Interval (2-Sided) 95%
1.23 to 2.40
Estimation Comments Ticagrelor/Placebo
4.Secondary Outcome
Title Composite of All-cause Mortality, MI or Stroke
Hide Description Time to first occurrence of any event from the composite of death from any causes, Myocardial Infarction (MI) and stroke (adjudicated by an ICEC). 1-year event rate (%) estimated via Kaplan-Meier method.
Time Frame Ongoing up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set which includes all randomized patients with available post-randomization efficacy data
Arm/Group Title Ticagrelor (AZD6140) Clopidogrel
Hide Arm/Group Description:
Ticagrelor (AZD6140) 90mg bid
Clopidogrel 75mg od
Overall Number of Participants Analyzed 400 400
Measure Type: Number
Unit of Measure: Percent probability
10.5 8.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ticagrelor (AZD6140), Clopidogrel
Comments No formal statistical comparison based on hypothesis test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments No P-value provided since the objective was not to perform formal statistical comparison.
Method Regression, Cox
Comments Analyzed based on proportional hazards model including treatment group only.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.51
Confidence Interval (2-Sided) 95%
0.91 to 2.50
Estimation Comments Ticagrelor/Placebo
Time Frame Approximately 6 months to 1 year.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ticagrelor (AZD6140) Clopidogrel
Hide Arm/Group Description Ticagrelor (AZD6140) 90mg bid Clopidogrel 75mg od
All-Cause Mortality
Ticagrelor (AZD6140) Clopidogrel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ticagrelor (AZD6140) Clopidogrel
Affected / at Risk (%) Affected / at Risk (%)
Total   92/387 (23.77%)   112/380 (29.47%) 
Blood and lymphatic system disorders     
Disseminated intravascular coagulation * 1  0/387 (0.00%)  1/380 (0.26%) 
Thrombocytopenia * 1  0/387 (0.00%)  1/380 (0.26%) 
Cardiac disorders     
Coronary artery stenosis * 1  36/387 (9.30%)  47/380 (12.37%) 
Angina pectoris * 1  5/387 (1.29%)  9/380 (2.37%) 
Angina unstable * 1  4/387 (1.03%)  5/380 (1.32%) 
Myocardial ischaemia * 1  2/387 (0.52%)  3/380 (0.79%) 
Acute myocardial infarction * 1  4/387 (1.03%)  2/380 (0.53%) 
Ventricular fibrillation * 1  3/387 (0.78%)  1/380 (0.26%) 
Cardiac failure * 1  1/387 (0.26%)  3/380 (0.79%) 
Cardiac failure congestive * 1  1/387 (0.26%)  2/380 (0.53%) 
Atrial fibrillation * 1  1/387 (0.26%)  1/380 (0.26%) 
Myocardial infarction * 1  1/387 (0.26%)  1/380 (0.26%) 
Cardiac failure chronic * 1  1/387 (0.26%)  0/380 (0.00%) 
Pericardial effusion * 1  1/387 (0.26%)  0/380 (0.00%) 
supraventricular tachycardia * 1  1/387 (0.26%)  0/380 (0.00%) 
Postinfarction angina * 1  1/387 (0.26%)  0/380 (0.00%) 
Pulseless electrical activity * 1  1/387 (0.26%)  0/380 (0.00%) 
Prinzmetal angina * 1  0/387 (0.00%)  2/380 (0.53%) 
Cardiac tamponade * 1  0/387 (0.00%)  1/380 (0.26%) 
Myocarditis * 1  0/387 (0.00%)  1/380 (0.26%) 
Pericarditis * 1  0/387 (0.00%)  1/380 (0.26%) 
Sinus arrest * 1  0/387 (0.00%)  1/380 (0.26%) 
Coronary artery dissection * 1  0/387 (0.00%)  1/380 (0.26%) 
coronary artery perforation * 1  0/387 (0.00%)  1/380 (0.26%) 
Congenital, familial and genetic disorders     
Anomalous arrangement of pancreaticobiliary duct * 1  0/387 (0.00%)  1/380 (0.26%) 
Ear and labyrinth disorders     
Vertigo * 1  1/387 (0.26%)  0/380 (0.00%) 
Sudden hearing loss * 1  1/387 (0.26%)  0/380 (0.00%) 
Eye disorders     
Cataract * 1  0/387 (0.00%)  1/380 (0.26%) 
Gastrointestinal disorders     
Colonic polyp * 1  1/387 (0.26%)  1/380 (0.26%) 
Loose tooth * 1  1/387 (0.26%)  0/380 (0.00%) 
Diarrhoea * 1  0/387 (0.00%)  1/380 (0.26%) 
Enterocolitis * 1  0/387 (0.00%)  1/380 (0.26%) 
Radicular cyst * 1  0/387 (0.00%)  1/380 (0.26%) 
Vomiting * 1  0/387 (0.00%)  1/380 (0.26%) 
Mechanical ileus * 1  1/387 (0.26%)  0/380 (0.00%) 
General disorders     
Thrombosis in device * 1  2/387 (0.52%)  4/380 (1.05%) 
Device occlusion * 1  1/387 (0.26%)  1/380 (0.26%) 
Chest pain * 1  1/387 (0.26%)  0/380 (0.00%) 
Non-cardiac chest pain * 1  1/387 (0.26%)  0/380 (0.00%) 
Hepatobiliary disorders     
Cholecystitis acute * 1  1/387 (0.26%)  1/380 (0.26%) 
Hepatic function abnormal * 1  0/387 (0.00%)  1/380 (0.26%) 
Cholecystitis * 1  0/387 (0.00%)  1/380 (0.26%) 
Infections and infestations     
Pneumonia * 1  1/387 (0.26%)  2/380 (0.53%) 
Upper respiratory tract infection * 1  1/387 (0.26%)  2/380 (0.53%) 
Herpes Zoster * 1  1/387 (0.26%)  2/380 (0.53%) 
Pyelonephritis * 1  1/387 (0.26%)  1/380 (0.26%) 
Bacteraemia * 1  1/387 (0.26%)  0/380 (0.00%) 
Urinary tract infection * 1  1/387 (0.26%)  0/380 (0.00%) 
Groin abscess * 1  1/387 (0.26%)  0/380 (0.00%) 
Pneumonia cryptococcal * 1  1/387 (0.26%)  0/380 (0.00%) 
Appendicitis * 1  0/387 (0.00%)  1/380 (0.26%) 
Hepatitis C * 1  0/387 (0.00%)  1/380 (0.26%) 
Otitis media acute * 1  0/387 (0.00%)  1/380 (0.26%) 
Cellulitis * 1  1/387 (0.26%)  0/380 (0.00%) 
Injury, poisoning and procedural complications     
In-stent coronary artery restenosis * 1  11/387 (2.84%)  10/380 (2.63%) 
Coronary artery restenosis * 1  6/387 (1.55%)  8/380 (2.11%) 
Spinal compression fracture * 1  2/387 (0.52%)  1/380 (0.26%) 
In-stent arterial restenosis * 1  2/387 (0.52%)  1/380 (0.26%) 
patella fracture * 1  1/387 (0.26%)  0/380 (0.00%) 
Tibia fracture * 1  1/387 (0.26%)  0/380 (0.00%) 
Post procedural myocardial infarction * 1  1/387 (0.26%)  0/380 (0.00%) 
Fat embolism * 1  0/387 (0.00%)  1/380 (0.26%) 
Incisional hernia * 1  0/387 (0.00%)  1/380 (0.26%) 
Radius fracture * 1  0/387 (0.00%)  1/380 (0.26%) 
Metabolism and nutrition disorders     
Hypovolaemia * 1  1/387 (0.26%)  0/380 (0.00%) 
Decreased appetite * 1  1/387 (0.26%)  0/380 (0.00%) 
Hypoglycaemia * 1  0/387 (0.00%)  2/380 (0.53%) 
Gout * 1  0/387 (0.00%)  1/380 (0.26%) 
Acidosis * 1  1/387 (0.26%)  0/380 (0.00%) 
Diabetes mellitus inadequate control * 1  1/387 (0.26%)  0/380 (0.00%) 
Hyperkalaemia * 1  1/387 (0.26%)  0/380 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  1/387 (0.26%)  0/380 (0.00%) 
Lumber spinal stenosis * 1  1/387 (0.26%)  0/380 (0.00%) 
Spinal column stenosis * 1  0/387 (0.00%)  1/380 (0.26%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung neoplasm malignant * 1  1/387 (0.26%)  1/380 (0.26%) 
Neuroma * 1  1/387 (0.26%)  0/380 (0.00%) 
Bladder cancer * 1  0/387 (0.00%)  2/380 (0.53%) 
Gastric cancer * 1  0/387 (0.00%)  1/380 (0.26%) 
Metastases to lymph nodes * 1  0/387 (0.00%)  1/380 (0.26%) 
Colon adenoma * 1  0/387 (0.00%)  1/380 (0.26%) 
Breast cancer female * 1  0/387 (0.00%)  1/380 (0.26%) 
Nervous system disorders     
Cerebral infarction * 1  4/387 (1.03%)  2/380 (0.53%) 
Hypoaesthesia * 1  0/387 (0.00%)  1/380 (0.26%) 
Loss of consciousness * 1  1/387 (0.26%)  0/380 (0.00%) 
Spondylitic myelopathy * 1  1/387 (0.26%)  0/380 (0.00%) 
Transient ischaemic attack * 1  1/387 (0.26%)  0/380 (0.00%) 
Intercostal neuralgia * 1  1/387 (0.26%)  0/380 (0.00%) 
Cerebrovascular accident * 1  0/387 (0.00%)  1/380 (0.26%) 
Embolic stroke * 1  0/387 (0.00%)  1/380 (0.26%) 
Headache * 1  0/387 (0.00%)  1/380 (0.26%) 
Parkinson's disease * 1  0/387 (0.00%)  1/380 (0.26%) 
Brain stem stroke * 1  0/387 (0.00%)  1/380 (0.26%) 
Metabolic encephalopathy * 1  1/387 (0.26%)  0/380 (0.00%) 
Psychiatric disorders     
Anxiety * 1  1/387 (0.26%)  0/380 (0.00%) 
Anxiety disorder * 1  0/387 (0.00%)  1/380 (0.26%) 
Renal and urinary disorders     
Nephrolithiasis * 1  1/387 (0.26%)  0/380 (0.00%) 
Ureteric stenosis * 1  1/387 (0.26%)  0/380 (0.00%) 
Renal failure chronic * 1  0/387 (0.00%)  2/380 (0.53%) 
Renal artery stenosis * 1  0/387 (0.00%)  1/380 (0.26%) 
Renal failure acute * 1  0/387 (0.00%)  1/380 (0.26%) 
Reproductive system and breast disorders     
Prostatitis * 1  1/387 (0.26%)  0/380 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  1/387 (0.26%)  0/380 (0.00%) 
Hyperventilation * 1  1/387 (0.26%)  0/380 (0.00%) 
Pulmonary oedema * 1  1/387 (0.26%)  0/380 (0.00%) 
Sleep apnoea syndrome * 1  0/387 (0.00%)  4/380 (1.05%) 
Pneumonia aspiration * 1  0/387 (0.00%)  2/380 (0.53%) 
Interstitial lung disease * 1  0/387 (0.00%)  1/380 (0.26%) 
Chronic obstructive pulmonary disease * 1  1/387 (0.26%)  1/380 (0.26%) 
Skin and subcutaneous tissue disorders     
Skin mass * 1  1/387 (0.26%)  0/380 (0.00%) 
Vascular disorders     
Arteriovenous fistula * 1  1/387 (0.26%)  0/380 (0.00%) 
Aortic dissection * 1  0/387 (0.00%)  1/380 (0.26%) 
Thrombosis * 1  0/387 (0.00%)  1/380 (0.26%) 
Femoral artery occlusion * 1  0/387 (0.00%)  1/380 (0.26%) 
Peripheral arterial occlusive disease * 1  0/387 (0.00%)  1/380 (0.26%) 
Aortic stenosis * 1  1/387 (0.26%)  0/380 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1.8%
Ticagrelor (AZD6140) Clopidogrel
Affected / at Risk (%) Affected / at Risk (%)
Total   327/387 (84.50%)   337/380 (88.68%) 
Blood and lymphatic system disorders     
Anaemia * 1  9/387 (2.33%)  9/380 (2.37%) 
Cardiac disorders     
Myocardial infarcion * 1  35/387 (9.04%)  23/380 (6.05%) 
Angina pectoris * 1  16/387 (4.13%)  22/380 (5.79%) 
Coronary artery stenosis * 1  14/387 (3.62%)  17/380 (4.47%) 
Bradycardia * 1  11/387 (2.84%)  8/380 (2.11%) 
Cardiac failure * 1  8/387 (2.07%)  8/380 (2.11%) 
Ventricular tachycardia * 1  8/387 (2.07%)  8/380 (2.11%) 
Ventricular extrasystoles * 1  7/387 (1.81%)  6/380 (1.58%) 
Atrial fibrillation * 1  5/387 (1.29%)  10/380 (2.63%) 
Gastrointestinal disorders     
Constipation * 1  59/387 (15.25%)  55/380 (14.47%) 
Diarrhoea * 1  26/387 (6.72%)  23/380 (6.05%) 
Vomiting * 1  21/387 (5.43%)  27/380 (7.11%) 
Nausea * 1  21/387 (5.43%)  26/380 (6.84%) 
Abdominal discomfort * 1  9/387 (2.33%)  9/380 (2.37%) 
Abdominal pain upper * 1  10/387 (2.58%)  3/380 (0.79%) 
Dental Caries * 1  3/387 (0.78%)  8/380 (2.11%) 
General disorders     
Pyrexia * 1  56/387 (14.47%)  51/380 (13.42%) 
Non-cardiac chest pain * 1  8/387 (2.07%)  1/380 (0.26%) 
Oedema peripheral * 1  8/387 (2.07%)  12/380 (3.16%) 
Puncture site pain * 1  6/387 (1.55%)  7/380 (1.84%) 
Hepatobiliary disorders     
Hepatic function abnormal * 1  10/387 (2.58%)  9/380 (2.37%) 
Infections and infestations     
Nasopharyngitis * 1  55/387 (14.21%)  59/380 (15.53%) 
Urinary tract infection * 1  10/387 (2.58%)  5/380 (1.32%) 
Pneumonia * 1  8/387 (2.07%)  3/380 (0.79%) 
Injury, poisoning and procedural complications     
In-stent coronary artery restenosis * 1  13/387 (3.36%)  12/380 (3.16%) 
Contusion * 1  10/387 (2.58%)  8/380 (2.11%) 
Procedural pain * 1  7/387 (1.81%)  1/380 (0.26%) 
Coronary artery restenosis * 1  6/387 (1.55%)  9/380 (2.37%) 
Metabolism and nutrition disorders     
Hyperuricaemia * 1  12/387 (3.10%)  6/380 (1.58%) 
Diabetes mellitus * 1  10/387 (2.58%)  5/380 (1.32%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  44/387 (11.37%)  46/380 (12.11%) 
Pain in extremity * 1  15/387 (3.88%)  10/380 (2.63%) 
Myalgia * 1  11/387 (2.84%)  6/380 (1.58%) 
Arthralgia * 1  10/387 (2.58%)  11/380 (2.89%) 
Musculoskeletal pain * 1  10/387 (2.58%)  10/380 (2.63%) 
Nervous system disorders     
Headache * 1  33/387 (8.53%)  57/380 (15.00%) 
Dizziness * 1  22/387 (5.68%)  18/380 (4.74%) 
Hypoaesthesia * 1  7/387 (1.81%)  12/380 (3.16%) 
Psychiatric disorders     
Insomnia * 1  58/387 (14.99%)  49/380 (12.89%) 
Restlessness * 1  14/387 (3.62%)  3/380 (0.79%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  23/387 (5.94%)  22/380 (5.79%) 
Dyspnoea * 1  22/387 (5.68%)  9/380 (2.37%) 
Upper respiratory tract inflammation * 1  8/387 (2.07%)  4/380 (1.05%) 
Sleep apnoea syndrome * 1  4/387 (1.03%)  8/380 (2.11%) 
Skin and subcutaneous tissue disorders     
Eczema * 1  16/387 (4.13%)  9/380 (2.37%) 
Rash * 1  13/387 (3.36%)  20/380 (5.26%) 
Blister * 1  8/387 (2.07%)  8/380 (2.11%) 
Dermatitis contact * 1  7/387 (1.81%)  5/380 (1.32%) 
Erythema * 1  6/387 (1.55%)  8/380 (2.11%) 
Pruritus * 1  7/387 (1.81%)  11/380 (2.89%) 
Vascular disorders     
Hypertension * 1  23/387 (5.94%)  27/380 (7.11%) 
Hypotension * 1  9/387 (2.33%)  6/380 (1.58%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
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
Name/Title: Judith Hsia
Organization: AstraZeneca
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01294462     History of Changes
Other Study ID Numbers: D5130C00027
First Submitted: February 10, 2011
First Posted: February 11, 2011
Results First Submitted: July 10, 2013
Results First Posted: May 2, 2014
Last Update Posted: June 27, 2014