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Ranolazine for Incomplete Vessel Revascularization Post-Percutaneous Coronary Intervention (PCI) (RIVER-PCI)

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ClinicalTrials.gov Identifier: NCT01442038
Recruitment Status : Completed
First Posted : September 28, 2011
Results First Posted : July 15, 2016
Last Update Posted : July 15, 2016
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Coronary Artery Disease
Angina Pectoris
Interventions Drug: Ranolazine
Drug: Placebo
Enrollment 2651

Recruitment Details Participants were enrolled at study sites in the United States, Canada, Europe, Russia, and Israel. The first participant was screened on 03 November 2011. The last study visit occurred on 09 February 2015.
Pre-assignment Details 2734 participants were screened.
Arm/Group Title Ranolazine Placebo
Hide Arm/Group Description Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study) Ranolazine placebo (1 tablet) for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
Period Title: Overall Study
Started 1332 1319
Completed 1029 1040
Not Completed 303 279
Reason Not Completed
Death             35             29
Investigator-Initiated Early Closure             44             43
Participant Withdrew Consent             137             102
Lost to Follow-up             37             51
Adverse Event             26             15
Protocol Deviation             9             20
Investigator's Discretion             13             16
Study Terminated By Sponsor             2             3
Arm/Group Title Ranolazine Placebo Total
Hide Arm/Group Description Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study) Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study) Total of all reporting groups
Overall Number of Baseline Participants 1322 1297 2619
Hide Baseline Analysis Population Description
Safety Analysis Set: participant who were randomized and received at least one dose of study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1322 participants 1297 participants 2619 participants
63.4  (10.51) 63.4  (10.06) 63.4  (10.29)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1322 participants 1297 participants 2619 participants
< 65 Years 714 719 1433
65-74 Years 402 383 785
≥ 75 Years 206 195 401
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1322 participants 1297 participants 2619 participants
Female
276
  20.9%
260
  20.0%
536
  20.5%
Male
1046
  79.1%
1037
  80.0%
2083
  79.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1322 participants 1297 participants 2619 participants
American Indian or Alaska Native 0 3 3
Asian 16 10 26
Black or African American 49 43 92
Native Hawaiian or Pacific Islander 2 1 3
White 1203 1196 2399
Other 29 28 57
Not Permitted 23 16 39
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1322 participants 1297 participants 2619 participants
Hispanic or Latino 72 64 136
Not Hispanic or Latino 1219 1208 2427
Not Reported 28 24 52
Unknown 3 1 4
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1322 participants 1297 participants 2619 participants
Russian Federation 154 168 322
United States 499 466 965
United Kingdom 16 17 33
Spain 80 87 167
Canada 80 85 165
Austria 12 15 27
Czech Republic 31 44 75
Netherlands 13 13 26
Sweden 19 25 44
Belgium 20 21 41
Poland 203 172 375
Italy 28 33 61
Israel 111 109 220
France 22 15 37
Germany 34 27 61
1.Primary Outcome
Title Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization
Hide Description Time to event distributions were estimated by the Kaplan-Meier (KM) method. 1 month = 28 days; 1 calendar year = 365 days.
Time Frame Baseline through end of study (average 90 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: all participants in the Safety Analysis Set (randomized and received at least one dose of study drug), except participants with no qualifying percutaneous coronary intervention (PCI; formerly known as angioplasty with stent))
Arm/Group Title Ranolazine Placebo
Hide Arm/Group Description:
Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
Overall Number of Participants Analyzed 1317 1287
Measure Type: Number
Unit of Measure: percentage of participants
KM Estimate: 1 Month 3.4 2.3
KM Estimate: 6 Months 11.3 10.0
KM Estimate: 12 Months 19.1 17.3
KM Estimate: 1 Calendar Year 20.2 18.9
KM Estimate: 18 Months 23.8 25.3
KM Estimate: 24 Months 27.6 29.4
KM Estimate: 2 Calendar Years 30.7 31.0
KM Estimate: 30 months 31.1 33.8
KM Estimate: 36 Months 32.2 37.8
KM Estimate: 3 Calendar Years NA [1]  37.8
[1]
NA = not calculable: all participants had an event or were censored prior to the Year 3 time point
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ranolazine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments The p-value and hazard ratio are from Cox proportional hazards model stratifying by reason for qualifying percutaneous coronary intervention (PCI): acute coronary syndrome (ACS) versus non-ACS indication, and history of diabetes (yes versus no).
Method Cox Proportional Hazards Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.948
Confidence Interval (2-Sided) 95%
0.818 to 1.099
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death
Hide Description Time to event distributions were estimated by the Kaplan-Meier method. 1 month = 28 days; 1 calendar year = 365 days.
Time Frame Baseline through end of study (average 90 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Ranolazine Placebo
Hide Arm/Group Description:
Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
Overall Number of Participants Analyzed 1317 1287
Measure Type: Number
Unit of Measure: percentage of participants
KM Estimate: 1 Month 0.2 0.1
KM Estimate: 6 Months 0.5 0.2
KM Estimate: 12 Months 0.5 0.5
KM Estimate: 1 Calendar Year 0.5 0.5
KM Estimate: 18 Months 0.5 0.8
KM Estimate: 24 Months 0.5 0.9
KM Estimate: 2 Calendar Years 0.7 0.9
KM Estimate: 30 months 0.7 0.9
KM Estimate: 36 Months 0.7 0.9
KM Estimate: 3 Calendar Years 0.7 0.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ranolazine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments The p-value and hazard ratio are from Cox proportional hazards model stratifying by reason for qualifying PCI: ACS versus non-ACS indication, and history of diabetes (yes versus no).
Method Cox Proportional Hazards Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.665
Confidence Interval (2-Sided) 95%
0.244 to 1.691
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death
Hide Description Time to event distributions were estimated by the Kaplan-Meier method. 1 month = 28 days; 1 calendar year = 365 days.
Time Frame Baseline through end of study (average 90 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Ranolazine Placebo
Hide Arm/Group Description:
Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
Overall Number of Participants Analyzed 1317 1287
Measure Type: Number
Unit of Measure: percentage of participants
KM Estimate: 1 Month 0.2 0.1
KM Estimate: 6 Months 0.6 0.4
KM Estimate: 12 Months 1.0 0.9
KM Estimate: 1 Calendar Year 1.1 1.0
KM Estimate: 18 Months 1.5 1.4
KM Estimate: 24 Months 1.7 1.7
KM Estimate: 2 Calendar Years 1.9 1.7
KM Estimate: 30 months 1.9 1.7
KM Estimate: 36 Months 1.9 1.7
KM Estimate: 3 Calendar Years 1.9 1.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ranolazine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.82
Comments The p-value and hazard ratio are from Cox proportional hazards model stratifying by reason for qualifying PCI: ACS versus non-ACS indication, and history of diabetes (yes versus no).
Method Cox Proportional Hazards Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.073
Confidence Interval (2-Sided) 95%
0.579 to 1.994
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction
Hide Description Time to event distributions were estimated by the Kaplan-Meier method. 1 month = 28 days; 1 calendar year = 365 days.
Time Frame Baseline through end of study (average 90 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Ranolazine Placebo
Hide Arm/Group Description:
Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
Overall Number of Participants Analyzed 1317 1287
Measure Type: Number
Unit of Measure: percentage of participants
KM Estimate: 1 Month 1.2 0.6
KM Estimate: 6 Months 3.8 3.3
KM Estimate: 12 Months 5.8 5.7
KM Estimate: 1 Calendar Year 6.2 6.2
KM Estimate: 18 Months 7.3 8.5
KM Estimate: 24 Months 8.7 9.4
KM Estimate: 2 Calendar Years 10.0 9.4
KM Estimate: 30 months 10.9 10.1
KM Estimate: 36 Months 10.9 13.4
KM Estimate: 3 Calendar Years 10.9 13.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ranolazine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.81
Comments The p-value and hazard ratio are from Cox proportional hazards model stratifying by reason for qualifying PCI: ACS versus non-ACS indication, and history of diabetes (yes versus no).
Method Cox Proportional Hazards Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.968
Confidence Interval (2-Sided) 95%
0.745 to 1.256
Estimation Comments [Not Specified]
Time Frame Baseline through end of study drug treatment (average exposure 72 weeks) plus 30 days
Adverse Event Reporting Description Safety Analysis Set: participants who were randomized and received at least one dose of study drug
 
Arm/Group Title Ranolazine Placebo
Hide Arm/Group Description Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study) Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
All-Cause Mortality
Ranolazine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ranolazine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   516/1322 (39.03%)   485/1297 (37.39%) 
Blood and lymphatic system disorders     
Anaemia  1  10/1322 (0.76%)  3/1297 (0.23%) 
Iron deficiency anaemia  1  2/1322 (0.15%)  1/1297 (0.08%) 
Leukocytosis  1  1/1322 (0.08%)  1/1297 (0.08%) 
Lymphadenopathy  1  1/1322 (0.08%)  0/1297 (0.00%) 
Normochromic normocytic anaemia  1  1/1322 (0.08%)  0/1297 (0.00%) 
Platelet dysfunction  1  1/1322 (0.08%)  0/1297 (0.00%) 
Cardiac disorders     
Acute coronary syndrome  1  2/1322 (0.15%)  9/1297 (0.69%) 
Acute myocardial infarction  1  28/1322 (2.12%)  29/1297 (2.24%) 
Angina pectoris  1  125/1322 (9.46%)  114/1297 (8.79%) 
Angina unstable  1  58/1322 (4.39%)  71/1297 (5.47%) 
Arrhythmia  1  1/1322 (0.08%)  0/1297 (0.00%) 
Arrhythmia supraventricular  1  2/1322 (0.15%)  0/1297 (0.00%) 
Arteriosclerosis coronary artery  1  0/1322 (0.00%)  2/1297 (0.15%) 
Atrial fibrillation  1  12/1322 (0.91%)  14/1297 (1.08%) 
Atrial flutter  1  5/1322 (0.38%)  0/1297 (0.00%) 
Atrioventricular block  1  1/1322 (0.08%)  1/1297 (0.08%) 
Atrioventricular block complete  1  1/1322 (0.08%)  0/1297 (0.00%) 
Atrioventricular block first degree  1  0/1322 (0.00%)  1/1297 (0.08%) 
Atrioventricular block second degree  1  0/1322 (0.00%)  2/1297 (0.15%) 
Bradycardia  1  5/1322 (0.38%)  3/1297 (0.23%) 
Cardiac arrest  1  5/1322 (0.38%)  3/1297 (0.23%) 
Cardiac failure  1  11/1322 (0.83%)  12/1297 (0.93%) 
Cardiac failure acute  1  2/1322 (0.15%)  2/1297 (0.15%) 
Cardiac failure chronic  1  0/1322 (0.00%)  2/1297 (0.15%) 
Cardiac failure congestive  1  20/1322 (1.51%)  6/1297 (0.46%) 
Cardiac tamponade  1  0/1322 (0.00%)  1/1297 (0.08%) 
Cardio-respiratory arrest  1  1/1322 (0.08%)  1/1297 (0.08%) 
Cardiogenic shock  1  1/1322 (0.08%)  1/1297 (0.08%) 
Cardiopulmonary failure  1  1/1322 (0.08%)  0/1297 (0.00%) 
Cardiorenal syndrome  1  0/1322 (0.00%)  1/1297 (0.08%) 
Conduction disorder  1  1/1322 (0.08%)  0/1297 (0.00%) 
Cor pulmonale  1  1/1322 (0.08%)  0/1297 (0.00%) 
Coronary artery disease  1  14/1322 (1.06%)  11/1297 (0.85%) 
Coronary artery insufficiency  1  0/1322 (0.00%)  1/1297 (0.08%) 
Coronary artery occlusion  1  1/1322 (0.08%)  1/1297 (0.08%) 
Coronary artery stenosis  1  2/1322 (0.15%)  2/1297 (0.15%) 
Ischaemic cardiomyopathy  1  2/1322 (0.15%)  4/1297 (0.31%) 
Left ventricular dysfunction  1  1/1322 (0.08%)  1/1297 (0.08%) 
Mitral valve incompetence  1  3/1322 (0.23%)  0/1297 (0.00%) 
Myocardial infarction  1  18/1322 (1.36%)  18/1297 (1.39%) 
Myocardial ischaemia  1  8/1322 (0.61%)  12/1297 (0.93%) 
Myocardial rupture  1  0/1322 (0.00%)  1/1297 (0.08%) 
Palpitations  1  1/1322 (0.08%)  0/1297 (0.00%) 
Pericarditis  1  1/1322 (0.08%)  0/1297 (0.00%) 
Postinfarction angina  1  1/1322 (0.08%)  1/1297 (0.08%) 
Right ventricular dysfunction  1  1/1322 (0.08%)  0/1297 (0.00%) 
Sinus arrest  1  1/1322 (0.08%)  0/1297 (0.00%) 
Sinus arrhythmia  1  0/1322 (0.00%)  1/1297 (0.08%) 
Sinus bradycardia  1  1/1322 (0.08%)  0/1297 (0.00%) 
Sinus tachycardia  1  1/1322 (0.08%)  0/1297 (0.00%) 
Supraventricular tachycardia  1  1/1322 (0.08%)  1/1297 (0.08%) 
Tachycardia  1  2/1322 (0.15%)  1/1297 (0.08%) 
Ventricular arrhythmia  1  0/1322 (0.00%)  2/1297 (0.15%) 
Ventricular dysfunction  1  1/1322 (0.08%)  0/1297 (0.00%) 
Ventricular fibrillation  1  1/1322 (0.08%)  2/1297 (0.15%) 
Ventricular tachyarrhythmia  1  1/1322 (0.08%)  0/1297 (0.00%) 
Ventricular tachycardia  1  5/1322 (0.38%)  4/1297 (0.31%) 
Wolff-Parkinson-White syndrome  1  1/1322 (0.08%)  0/1297 (0.00%) 
Congenital, familial and genetic disorders     
Atrial septal defect  1  1/1322 (0.08%)  0/1297 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  1/1322 (0.08%)  3/1297 (0.23%) 
Vestibular disorder  1  0/1322 (0.00%)  1/1297 (0.08%) 
Endocrine disorders     
Adrenal insufficiency  1  1/1322 (0.08%)  0/1297 (0.00%) 
Hyperthyroidism  1  1/1322 (0.08%)  1/1297 (0.08%) 
Eye disorders     
Cataract  1  0/1322 (0.00%)  1/1297 (0.08%) 
Hyphaema  1  0/1322 (0.00%)  1/1297 (0.08%) 
Retinal detachment  1  0/1322 (0.00%)  1/1297 (0.08%) 
Gastrointestinal disorders     
Abdominal discomfort  1  0/1322 (0.00%)  1/1297 (0.08%) 
Abdominal hernia  1  0/1322 (0.00%)  1/1297 (0.08%) 
Abdominal pain  1  3/1322 (0.23%)  2/1297 (0.15%) 
Abdominal pain lower  1  1/1322 (0.08%)  0/1297 (0.00%) 
Abdominal pain upper  1  2/1322 (0.15%)  0/1297 (0.00%) 
Anal fissure  1  0/1322 (0.00%)  1/1297 (0.08%) 
Ascites  1  0/1322 (0.00%)  1/1297 (0.08%) 
Chronic gastrointestinal bleeding  1  0/1322 (0.00%)  1/1297 (0.08%) 
Colitis  1  2/1322 (0.15%)  0/1297 (0.00%) 
Colitis ischaemic  1  3/1322 (0.23%)  0/1297 (0.00%) 
Constipation  1  1/1322 (0.08%)  1/1297 (0.08%) 
Crohn's disease  1  0/1322 (0.00%)  1/1297 (0.08%) 
Diarrhoea  1  3/1322 (0.23%)  0/1297 (0.00%) 
Diverticular perforation  1  1/1322 (0.08%)  0/1297 (0.00%) 
Diverticulum  1  1/1322 (0.08%)  0/1297 (0.00%) 
Diverticulum intestinal  1  0/1322 (0.00%)  1/1297 (0.08%) 
Duodenal ulcer  1  1/1322 (0.08%)  2/1297 (0.15%) 
Duodenitis  1  2/1322 (0.15%)  0/1297 (0.00%) 
Dysphagia  1  1/1322 (0.08%)  0/1297 (0.00%) 
Gastric ulcer  1  1/1322 (0.08%)  0/1297 (0.00%) 
Gastritis  1  2/1322 (0.15%)  0/1297 (0.00%) 
Gastritis erosive  1  0/1322 (0.00%)  1/1297 (0.08%) 
Gastrointestinal haemorrhage  1  8/1322 (0.61%)  13/1297 (1.00%) 
Gastrointestinal perforation  1  1/1322 (0.08%)  0/1297 (0.00%) 
Gastrointestinal polyp haemorrhage  1  1/1322 (0.08%)  0/1297 (0.00%) 
Gastrooesophageal reflux disease  1  0/1322 (0.00%)  1/1297 (0.08%) 
Haematemesis  1  1/1322 (0.08%)  0/1297 (0.00%) 
Haematochezia  1  1/1322 (0.08%)  0/1297 (0.00%) 
Haemorrhoids  1  0/1322 (0.00%)  1/1297 (0.08%) 
Ileus  1  2/1322 (0.15%)  1/1297 (0.08%) 
Ileus paralytic  1  1/1322 (0.08%)  0/1297 (0.00%) 
Inguinal hernia  1  2/1322 (0.15%)  2/1297 (0.15%) 
Intestinal angina  1  0/1322 (0.00%)  1/1297 (0.08%) 
Intestinal haemorrhage  1  0/1322 (0.00%)  1/1297 (0.08%) 
Intestinal mass  1  0/1322 (0.00%)  1/1297 (0.08%) 
Intestinal obstruction  1  0/1322 (0.00%)  1/1297 (0.08%) 
Intestinal perforation  1  2/1322 (0.15%)  0/1297 (0.00%) 
Intra-abdominal haemorrhage  1  0/1322 (0.00%)  1/1297 (0.08%) 
Large intestine polyp  1  1/1322 (0.08%)  0/1297 (0.00%) 
Lip disorder  1  1/1322 (0.08%)  0/1297 (0.00%) 
Lower gastrointestinal haemorrhage  1  2/1322 (0.15%)  0/1297 (0.00%) 
Mesenteric artery thrombosis  1  1/1322 (0.08%)  0/1297 (0.00%) 
Nausea  1  4/1322 (0.30%)  1/1297 (0.08%) 
Oesophagitis  1  0/1322 (0.00%)  1/1297 (0.08%) 
Pancreatitis  1  1/1322 (0.08%)  0/1297 (0.00%) 
Pancreatitis acute  1  0/1322 (0.00%)  1/1297 (0.08%) 
Pancreatitis chronic  1  0/1322 (0.00%)  1/1297 (0.08%) 
Proctitis  1  0/1322 (0.00%)  1/1297 (0.08%) 
Radicular cyst  1  0/1322 (0.00%)  1/1297 (0.08%) 
Rectal haemorrhage  1  6/1322 (0.45%)  0/1297 (0.00%) 
Retroperitoneal haematoma  1  1/1322 (0.08%)  1/1297 (0.08%) 
Small intestinal obstruction  1  1/1322 (0.08%)  0/1297 (0.00%) 
Small intestinal ulcer haemorrhage  1  0/1322 (0.00%)  1/1297 (0.08%) 
Vomiting  1  4/1322 (0.30%)  3/1297 (0.23%) 
General disorders     
Arterial restenosis  1  0/1322 (0.00%)  2/1297 (0.15%) 
Asthenia  1  3/1322 (0.23%)  0/1297 (0.00%) 
Carotid artery restenosis  1  1/1322 (0.08%)  0/1297 (0.00%) 
Chest discomfort  1  2/1322 (0.15%)  3/1297 (0.23%) 
Chest pain  1  37/1322 (2.80%)  24/1297 (1.85%) 
Coronary artery restenosis  1  1/1322 (0.08%)  2/1297 (0.15%) 
Death  1  1/1322 (0.08%)  1/1297 (0.08%) 
Device extrusion  1  0/1322 (0.00%)  1/1297 (0.08%) 
Device malfunction  1  0/1322 (0.00%)  1/1297 (0.08%) 
Face oedema  1  1/1322 (0.08%)  0/1297 (0.00%) 
Fatigue  1  2/1322 (0.15%)  0/1297 (0.00%) 
Impaired healing  1  1/1322 (0.08%)  0/1297 (0.00%) 
Multi-organ disorder  1  0/1322 (0.00%)  1/1297 (0.08%) 
Multi-organ failure  1  0/1322 (0.00%)  3/1297 (0.23%) 
Non-cardiac chest pain  1  19/1322 (1.44%)  19/1297 (1.46%) 
Oedema peripheral  1  0/1322 (0.00%)  1/1297 (0.08%) 
Peripheral artery restenosis  1  1/1322 (0.08%)  1/1297 (0.08%) 
Pyrexia  1  2/1322 (0.15%)  2/1297 (0.15%) 
Sudden cardiac death  1  2/1322 (0.15%)  1/1297 (0.08%) 
Thrombosis in device  1  1/1322 (0.08%)  0/1297 (0.00%) 
Ulcer haemorrhage  1  1/1322 (0.08%)  0/1297 (0.00%) 
Hepatobiliary disorders     
Biliary colic  1  1/1322 (0.08%)  0/1297 (0.00%) 
Cholecystitis  1  0/1322 (0.00%)  1/1297 (0.08%) 
Cholecystitis acute  1  2/1322 (0.15%)  1/1297 (0.08%) 
Cholelithiasis  1  1/1322 (0.08%)  2/1297 (0.15%) 
Hepatic cirrhosis  1  0/1322 (0.00%)  1/1297 (0.08%) 
Immune system disorders     
Drug hypersensitivity  1  1/1322 (0.08%)  0/1297 (0.00%) 
Infections and infestations     
Abdominal wall abscess  1  1/1322 (0.08%)  0/1297 (0.00%) 
Abscess limb  1  2/1322 (0.15%)  1/1297 (0.08%) 
Abscess neck  1  0/1322 (0.00%)  1/1297 (0.08%) 
Appendicitis  1  3/1322 (0.23%)  3/1297 (0.23%) 
Appendicitis perforated  1  0/1322 (0.00%)  1/1297 (0.08%) 
Bronchitis  1  1/1322 (0.08%)  4/1297 (0.31%) 
Bronchitis bacterial  1  1/1322 (0.08%)  0/1297 (0.00%) 
Bronchopneumonia  1  1/1322 (0.08%)  1/1297 (0.08%) 
Bursitis infective  1  0/1322 (0.00%)  2/1297 (0.15%) 
Cellulitis  1  5/1322 (0.38%)  2/1297 (0.15%) 
Cholangitis infective  1  1/1322 (0.08%)  0/1297 (0.00%) 
Clostridium difficile colitis  1  1/1322 (0.08%)  0/1297 (0.00%) 
Clostridium difficile infection  1  0/1322 (0.00%)  1/1297 (0.08%) 
Creutzfeldt-Jakob disease  1  1/1322 (0.08%)  0/1297 (0.00%) 
Cystitis  1  1/1322 (0.08%)  0/1297 (0.00%) 
Device related infection  1  0/1322 (0.00%)  2/1297 (0.15%) 
Diarrhoea infectious  1  1/1322 (0.08%)  0/1297 (0.00%) 
Diverticulitis  1  4/1322 (0.30%)  1/1297 (0.08%) 
Endocarditis bacterial  1  0/1322 (0.00%)  1/1297 (0.08%) 
Enterocolitis bacterial  1  0/1322 (0.00%)  1/1297 (0.08%) 
Erysipelas  1  1/1322 (0.08%)  1/1297 (0.08%) 
Gastroenteritis  1  3/1322 (0.23%)  2/1297 (0.15%) 
Gastroenteritis viral  1  0/1322 (0.00%)  2/1297 (0.15%) 
Gingival abscess  1  0/1322 (0.00%)  1/1297 (0.08%) 
Groin abscess  1  0/1322 (0.00%)  1/1297 (0.08%) 
Herpes zoster oticus  1  0/1322 (0.00%)  1/1297 (0.08%) 
Infection  1  0/1322 (0.00%)  1/1297 (0.08%) 
Influenza  1  1/1322 (0.08%)  1/1297 (0.08%) 
Localised infection  1  1/1322 (0.08%)  0/1297 (0.00%) 
Orchitis  1  0/1322 (0.00%)  1/1297 (0.08%) 
Osteomyelitis  1  2/1322 (0.15%)  1/1297 (0.08%) 
Osteomyelitis acute  1  1/1322 (0.08%)  0/1297 (0.00%) 
Otitis externa  1  0/1322 (0.00%)  1/1297 (0.08%) 
Pneumonia  1  14/1322 (1.06%)  12/1297 (0.93%) 
Postoperative abscess  1  1/1322 (0.08%)  0/1297 (0.00%) 
Postoperative wound infection  1  1/1322 (0.08%)  0/1297 (0.00%) 
Pulmonary tuberculosis  1  1/1322 (0.08%)  0/1297 (0.00%) 
Pyelonephritis acute  1  1/1322 (0.08%)  3/1297 (0.23%) 
Respiratory tract infection viral  1  1/1322 (0.08%)  0/1297 (0.00%) 
Sepsis  1  6/1322 (0.45%)  1/1297 (0.08%) 
Sepsis syndrome  1  0/1322 (0.00%)  1/1297 (0.08%) 
Septic shock  1  3/1322 (0.23%)  1/1297 (0.08%) 
Skin infection  1  0/1322 (0.00%)  1/1297 (0.08%) 
Subcutaneous abscess  1  1/1322 (0.08%)  0/1297 (0.00%) 
Tuberculosis  1  1/1322 (0.08%)  0/1297 (0.00%) 
Urinary tract infection  1  2/1322 (0.15%)  6/1297 (0.46%) 
Urinary tract infection bacterial  1  0/1322 (0.00%)  1/1297 (0.08%) 
Urosepsis  1  2/1322 (0.15%)  1/1297 (0.08%) 
Viral upper respiratory tract infection  1  1/1322 (0.08%)  0/1297 (0.00%) 
Wound infection  1  1/1322 (0.08%)  2/1297 (0.15%) 
Injury, poisoning and procedural complications     
Anaemia postoperative  1  0/1322 (0.00%)  1/1297 (0.08%) 
Chest injury  1  1/1322 (0.08%)  0/1297 (0.00%) 
Concussion  1  0/1322 (0.00%)  1/1297 (0.08%) 
Craniocerebral injury  1  0/1322 (0.00%)  1/1297 (0.08%) 
Facial bones fracture  1  1/1322 (0.08%)  0/1297 (0.00%) 
Fall  1  0/1322 (0.00%)  1/1297 (0.08%) 
Femur fracture  1  1/1322 (0.08%)  0/1297 (0.00%) 
Foot fracture  1  0/1322 (0.00%)  1/1297 (0.08%) 
Graft thrombosis  1  1/1322 (0.08%)  0/1297 (0.00%) 
Head injury  1  3/1322 (0.23%)  1/1297 (0.08%) 
Hip fracture  1  1/1322 (0.08%)  1/1297 (0.08%) 
Humerus fracture  1  1/1322 (0.08%)  0/1297 (0.00%) 
Laceration  1  1/1322 (0.08%)  2/1297 (0.15%) 
Limb injury  1  1/1322 (0.08%)  0/1297 (0.00%) 
Lower limb fracture  1  1/1322 (0.08%)  0/1297 (0.00%) 
Lumbar vertebral fracture  1  1/1322 (0.08%)  0/1297 (0.00%) 
Muscle rupture  1  1/1322 (0.08%)  0/1297 (0.00%) 
Overdose  1  2/1322 (0.15%)  0/1297 (0.00%) 
Pelvic fracture  1  1/1322 (0.08%)  0/1297 (0.00%) 
Periorbital haematoma  1  1/1322 (0.08%)  0/1297 (0.00%) 
Peripheral arterial reocclusion  1  1/1322 (0.08%)  0/1297 (0.00%) 
Post procedural complication  1  1/1322 (0.08%)  0/1297 (0.00%) 
Post procedural fistula  1  0/1322 (0.00%)  1/1297 (0.08%) 
Post procedural haematoma  1  0/1322 (0.00%)  1/1297 (0.08%) 
Post procedural haemorrhage  1  0/1322 (0.00%)  1/1297 (0.08%) 
Postoperative hernia  1  1/1322 (0.08%)  0/1297 (0.00%) 
Postoperative wound complication  1  1/1322 (0.08%)  0/1297 (0.00%) 
Postpericardiotomy syndrome  1  1/1322 (0.08%)  0/1297 (0.00%) 
Procedural pain  1  0/1322 (0.00%)  1/1297 (0.08%) 
Pubis fracture  1  1/1322 (0.08%)  0/1297 (0.00%) 
Rib fracture  1  2/1322 (0.15%)  0/1297 (0.00%) 
Road traffic accident  1  1/1322 (0.08%)  1/1297 (0.08%) 
Subcutaneous haematoma  1  0/1322 (0.00%)  1/1297 (0.08%) 
Subdural haematoma  1  1/1322 (0.08%)  0/1297 (0.00%) 
Subdural haemorrhage  1  1/1322 (0.08%)  0/1297 (0.00%) 
Upper limb fracture  1  1/1322 (0.08%)  0/1297 (0.00%) 
Vascular graft complication  1  1/1322 (0.08%)  0/1297 (0.00%) 
Vascular pseudoaneurysm  1  1/1322 (0.08%)  0/1297 (0.00%) 
Investigations     
Cardiac stress test abnormal  1  1/1322 (0.08%)  1/1297 (0.08%) 
Ejection fraction decreased  1  1/1322 (0.08%)  0/1297 (0.00%) 
Electrocardiogram ST segment depression  1  0/1322 (0.00%)  1/1297 (0.08%) 
Hepatic enzyme increased  1  0/1322 (0.00%)  1/1297 (0.08%) 
Metabolism and nutrition disorders     
Dehydration  1  2/1322 (0.15%)  1/1297 (0.08%) 
Diabetes mellitus inadequate control  1  1/1322 (0.08%)  0/1297 (0.00%) 
Diabetic ketoacidosis  1  1/1322 (0.08%)  0/1297 (0.00%) 
Electrolyte imbalance  1  1/1322 (0.08%)  0/1297 (0.00%) 
Fluid overload  1  0/1322 (0.00%)  1/1297 (0.08%) 
Gout  1  0/1322 (0.00%)  1/1297 (0.08%) 
Hyperglycaemia  1  2/1322 (0.15%)  1/1297 (0.08%) 
Hyperkalaemia  1  4/1322 (0.30%)  0/1297 (0.00%) 
Hypoglycaemia  1  4/1322 (0.30%)  2/1297 (0.15%) 
Hypokalaemia  1  0/1322 (0.00%)  2/1297 (0.15%) 
Hypomagnesaemia  1  1/1322 (0.08%)  0/1297 (0.00%) 
Hyponatraemia  1  4/1322 (0.30%)  1/1297 (0.08%) 
Hypovolaemia  1  2/1322 (0.15%)  0/1297 (0.00%) 
Type 2 diabetes mellitus  1  0/1322 (0.00%)  1/1297 (0.08%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/1322 (0.08%)  1/1297 (0.08%) 
Arthritis  1  0/1322 (0.00%)  1/1297 (0.08%) 
Back pain  1  2/1322 (0.15%)  2/1297 (0.15%) 
Cervical spinal stenosis  1  0/1322 (0.00%)  1/1297 (0.08%) 
Intervertebral disc protrusion  1  0/1322 (0.00%)  1/1297 (0.08%) 
Lumbar spinal stenosis  1  1/1322 (0.08%)  1/1297 (0.08%) 
Musculoskeletal chest pain  1  2/1322 (0.15%)  1/1297 (0.08%) 
Musculoskeletal pain  1  2/1322 (0.15%)  0/1297 (0.00%) 
Myalgia  1  1/1322 (0.08%)  0/1297 (0.00%) 
Neck mass  1  1/1322 (0.08%)  0/1297 (0.00%) 
Neck pain  1  1/1322 (0.08%)  1/1297 (0.08%) 
Osteoarthritis  1  5/1322 (0.38%)  1/1297 (0.08%) 
Osteochondrosis  1  1/1322 (0.08%)  0/1297 (0.00%) 
Polyarthritis  1  0/1322 (0.00%)  1/1297 (0.08%) 
Psoriatic arthropathy  1  1/1322 (0.08%)  0/1297 (0.00%) 
Rhabdomyolysis  1  2/1322 (0.15%)  1/1297 (0.08%) 
Rotator cuff syndrome  1  2/1322 (0.15%)  1/1297 (0.08%) 
Spinal column stenosis  1  0/1322 (0.00%)  3/1297 (0.23%) 
Spinal disorder  1  0/1322 (0.00%)  1/1297 (0.08%) 
Spinal osteoarthritis  1  1/1322 (0.08%)  1/1297 (0.08%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma of colon  1  1/1322 (0.08%)  0/1297 (0.00%) 
Adrenal adenoma  1  1/1322 (0.08%)  0/1297 (0.00%) 
Bladder adenocarcinoma stage unspecified  1  2/1322 (0.15%)  0/1297 (0.00%) 
Bladder cancer  1  0/1322 (0.00%)  1/1297 (0.08%) 
Bladder cancer stage 0, with cancer in situ  1  1/1322 (0.08%)  0/1297 (0.00%) 
Bladder neoplasm  1  1/1322 (0.08%)  1/1297 (0.08%) 
Bladder transitional cell carcinoma  1  0/1322 (0.00%)  2/1297 (0.15%) 
Breast cancer  1  1/1322 (0.08%)  0/1297 (0.00%) 
Bronchial carcinoma  1  1/1322 (0.08%)  0/1297 (0.00%) 
Cholangiocarcinoma  1  0/1322 (0.00%)  1/1297 (0.08%) 
Colon neoplasm  1  0/1322 (0.00%)  1/1297 (0.08%) 
Endometrial cancer  1  0/1322 (0.00%)  1/1297 (0.08%) 
Endometrial cancer stage I  1  1/1322 (0.08%)  0/1297 (0.00%) 
Fibrous histiocytoma  1  0/1322 (0.00%)  1/1297 (0.08%) 
Glioblastoma  1  0/1322 (0.00%)  1/1297 (0.08%) 
Leukaemia  1  1/1322 (0.08%)  0/1297 (0.00%) 
Lung adenocarcinoma  1  1/1322 (0.08%)  0/1297 (0.00%) 
Lung neoplasm  1  0/1322 (0.00%)  1/1297 (0.08%) 
Lung neoplasm malignant  1  0/1322 (0.00%)  1/1297 (0.08%) 
Malignant melanoma  1  1/1322 (0.08%)  1/1297 (0.08%) 
Metastases to peritoneum  1  0/1322 (0.00%)  1/1297 (0.08%) 
Neoplasm  1  0/1322 (0.00%)  1/1297 (0.08%) 
Neoplasm malignant  1  1/1322 (0.08%)  0/1297 (0.00%) 
Oesophageal adenocarcinoma  1  1/1322 (0.08%)  0/1297 (0.00%) 
Oesophageal carcinoma  1  1/1322 (0.08%)  0/1297 (0.00%) 
Pancreatic carcinoma metastatic  1  0/1322 (0.00%)  1/1297 (0.08%) 
Plasma cell myeloma  1  1/1322 (0.08%)  0/1297 (0.00%) 
Prostate cancer  1  3/1322 (0.23%)  1/1297 (0.08%) 
Renal cell carcinoma  1  0/1322 (0.00%)  1/1297 (0.08%) 
Salivary gland neoplasm  1  0/1322 (0.00%)  1/1297 (0.08%) 
Small cell lung cancer  1  1/1322 (0.08%)  0/1297 (0.00%) 
Squamous cell carcinoma  1  1/1322 (0.08%)  1/1297 (0.08%) 
Squamous cell carcinoma of skin  1  2/1322 (0.15%)  0/1297 (0.00%) 
Testis cancer  1  0/1322 (0.00%)  1/1297 (0.08%) 
Thyroid neoplasm  1  1/1322 (0.08%)  0/1297 (0.00%) 
Transitional cell carcinoma  1  0/1322 (0.00%)  1/1297 (0.08%) 
Uterine cancer  1  2/1322 (0.15%)  0/1297 (0.00%) 
Nervous system disorders     
Balance disorder  1  0/1322 (0.00%)  1/1297 (0.08%) 
Brain oedema  1  0/1322 (0.00%)  1/1297 (0.08%) 
Carotid artery aneurysm  1  1/1322 (0.08%)  0/1297 (0.00%) 
Carotid artery dissection  1  0/1322 (0.00%)  1/1297 (0.08%) 
Carotid artery occlusion  1  0/1322 (0.00%)  1/1297 (0.08%) 
Carotid artery stenosis  1  8/1322 (0.61%)  2/1297 (0.15%) 
Cerebellar infarction  1  0/1322 (0.00%)  1/1297 (0.08%) 
Cerebral haematoma  1  1/1322 (0.08%)  0/1297 (0.00%) 
Cerebral haemorrhage  1  1/1322 (0.08%)  0/1297 (0.00%) 
Cerebral infarction  1  1/1322 (0.08%)  1/1297 (0.08%) 
Cerebrovascular accident  1  12/1322 (0.91%)  9/1297 (0.69%) 
Dizziness  1  5/1322 (0.38%)  1/1297 (0.08%) 
Dysarthria  1  1/1322 (0.08%)  0/1297 (0.00%) 
Generalised tonic-clonic seizure  1  1/1322 (0.08%)  0/1297 (0.00%) 
Guillain-Barre syndrome  1  1/1322 (0.08%)  0/1297 (0.00%) 
Haemorrhagic transformation stroke  1  0/1322 (0.00%)  1/1297 (0.08%) 
Headache  1  2/1322 (0.15%)  2/1297 (0.15%) 
Intracranial pressure increased  1  1/1322 (0.08%)  0/1297 (0.00%) 
Ischaemic stroke  1  5/1322 (0.38%)  1/1297 (0.08%) 
Lacunar infarction  1  0/1322 (0.00%)  2/1297 (0.15%) 
Lateral medullary syndrome  1  1/1322 (0.08%)  0/1297 (0.00%) 
Loss of consciousness  1  2/1322 (0.15%)  0/1297 (0.00%) 
Lumbar radiculopathy  1  1/1322 (0.08%)  0/1297 (0.00%) 
Mononeuropathy  1  0/1322 (0.00%)  1/1297 (0.08%) 
Muscle contractions involuntary  1  0/1322 (0.00%)  1/1297 (0.08%) 
Myasthenia gravis  1  0/1322 (0.00%)  1/1297 (0.08%) 
Myelopathy  1  1/1322 (0.08%)  1/1297 (0.08%) 
Paraesthesia  1  1/1322 (0.08%)  0/1297 (0.00%) 
Presyncope  1  9/1322 (0.68%)  2/1297 (0.15%) 
Radicular pain  1  1/1322 (0.08%)  0/1297 (0.00%) 
Sciatica  1  0/1322 (0.00%)  1/1297 (0.08%) 
Subarachnoid haemorrhage  1  1/1322 (0.08%)  0/1297 (0.00%) 
Syncope  1  25/1322 (1.89%)  13/1297 (1.00%) 
Toxic encephalopathy  1  1/1322 (0.08%)  0/1297 (0.00%) 
Transient ischaemic attack  1  12/1322 (0.91%)  3/1297 (0.23%) 
Tremor  1  1/1322 (0.08%)  0/1297 (0.00%) 
Vertebral artery stenosis  1  0/1322 (0.00%)  1/1297 (0.08%) 
Psychiatric disorders     
Delusional disorder, unspecified type  1  1/1322 (0.08%)  0/1297 (0.00%) 
Depression  1  3/1322 (0.23%)  1/1297 (0.08%) 
Major depression  1  0/1322 (0.00%)  1/1297 (0.08%) 
Mental status changes  1  2/1322 (0.15%)  4/1297 (0.31%) 
Suicidal ideation  1  1/1322 (0.08%)  0/1297 (0.00%) 
Renal and urinary disorders     
Bladder outlet obstruction  1  0/1322 (0.00%)  1/1297 (0.08%) 
Diabetic nephropathy  1  1/1322 (0.08%)  0/1297 (0.00%) 
Haematuria  1  1/1322 (0.08%)  4/1297 (0.31%) 
Nephropathy  1  1/1322 (0.08%)  0/1297 (0.00%) 
Nephrotic syndrome  1  1/1322 (0.08%)  0/1297 (0.00%) 
Renal artery stenosis  1  1/1322 (0.08%)  0/1297 (0.00%) 
Renal colic  1  0/1322 (0.00%)  1/1297 (0.08%) 
Renal failure  1  4/1322 (0.30%)  0/1297 (0.00%) 
Renal failure acute  1  5/1322 (0.38%)  6/1297 (0.46%) 
Renal failure chronic  1  1/1322 (0.08%)  0/1297 (0.00%) 
Renal infarct  1  1/1322 (0.08%)  0/1297 (0.00%) 
Urinary incontinence  1  0/1322 (0.00%)  1/1297 (0.08%) 
Urinary retention  1  0/1322 (0.00%)  2/1297 (0.15%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  0/1322 (0.00%)  4/1297 (0.31%) 
Epididymal cyst  1  0/1322 (0.00%)  1/1297 (0.08%) 
Prostatitis  1  2/1322 (0.15%)  0/1297 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  1/1322 (0.08%)  1/1297 (0.08%) 
Asthma  1  0/1322 (0.00%)  1/1297 (0.08%) 
Bronchitis chronic  1  0/1322 (0.00%)  1/1297 (0.08%) 
Chronic obstructive pulmonary disease  1  5/1322 (0.38%)  7/1297 (0.54%) 
Dyspnoea  1  13/1322 (0.98%)  13/1297 (1.00%) 
Dyspnoea exertional  1  2/1322 (0.15%)  4/1297 (0.31%) 
Epistaxis  1  1/1322 (0.08%)  2/1297 (0.15%) 
Haemoptysis  1  1/1322 (0.08%)  0/1297 (0.00%) 
Hypoxia  1  1/1322 (0.08%)  0/1297 (0.00%) 
Laryngeal stenosis  1  1/1322 (0.08%)  0/1297 (0.00%) 
Lung consolidation  1  1/1322 (0.08%)  0/1297 (0.00%) 
Pharyngeal haemorrhage  1  0/1322 (0.00%)  1/1297 (0.08%) 
Pleural effusion  1  1/1322 (0.08%)  2/1297 (0.15%) 
Pneumonia aspiration  1  0/1322 (0.00%)  1/1297 (0.08%) 
Pneumothorax  1  1/1322 (0.08%)  2/1297 (0.15%) 
Pneumothorax spontaneous  1  0/1322 (0.00%)  1/1297 (0.08%) 
Pulmonary congestion  1  1/1322 (0.08%)  0/1297 (0.00%) 
Pulmonary embolism  1  1/1322 (0.08%)  2/1297 (0.15%) 
Pulmonary fibrosis  1  0/1322 (0.00%)  1/1297 (0.08%) 
Pulmonary hypertension  1  1/1322 (0.08%)  0/1297 (0.00%) 
Pulmonary oedema  1  2/1322 (0.15%)  4/1297 (0.31%) 
Respiratory disorder  1  1/1322 (0.08%)  0/1297 (0.00%) 
Respiratory distress  1  1/1322 (0.08%)  0/1297 (0.00%) 
Respiratory failure  1  2/1322 (0.15%)  1/1297 (0.08%) 
Tonsillar hypertrophy  1  0/1322 (0.00%)  1/1297 (0.08%) 
Tracheal stenosis  1  1/1322 (0.08%)  0/1297 (0.00%) 
Skin and subcutaneous tissue disorders     
Angioedema  1  1/1322 (0.08%)  0/1297 (0.00%) 
Diabetic foot  1  1/1322 (0.08%)  0/1297 (0.00%) 
Dry gangrene  1  1/1322 (0.08%)  0/1297 (0.00%) 
Hyperhidrosis  1  1/1322 (0.08%)  0/1297 (0.00%) 
Psoriasis  1  0/1322 (0.00%)  1/1297 (0.08%) 
Rash  1  0/1322 (0.00%)  1/1297 (0.08%) 
Rash generalised  1  0/1322 (0.00%)  1/1297 (0.08%) 
Skin lesion  1  0/1322 (0.00%)  1/1297 (0.08%) 
Skin ulcer  1  0/1322 (0.00%)  1/1297 (0.08%) 
Vascular disorders     
Aortic aneurysm  1  5/1322 (0.38%)  2/1297 (0.15%) 
Aortic stenosis  1  3/1322 (0.23%)  0/1297 (0.00%) 
Arterial stenosis  1  0/1322 (0.00%)  1/1297 (0.08%) 
Arteriosclerosis  1  0/1322 (0.00%)  1/1297 (0.08%) 
Deep vein thrombosis  1  4/1322 (0.30%)  1/1297 (0.08%) 
Extremity necrosis  1  0/1322 (0.00%)  1/1297 (0.08%) 
Femoral artery occlusion  1  1/1322 (0.08%)  0/1297 (0.00%) 
Hypertension  1  9/1322 (0.68%)  3/1297 (0.23%) 
Hypertensive crisis  1  1/1322 (0.08%)  2/1297 (0.15%) 
Hypertensive emergency  1  2/1322 (0.15%)  0/1297 (0.00%) 
Hypotension  1  7/1322 (0.53%)  1/1297 (0.08%) 
Hypovolaemic shock  1  1/1322 (0.08%)  0/1297 (0.00%) 
Intermittent claudication  1  3/1322 (0.23%)  0/1297 (0.00%) 
Ischaemia  1  0/1322 (0.00%)  1/1297 (0.08%) 
Lymphorrhoea  1  0/1322 (0.00%)  1/1297 (0.08%) 
Malignant hypertension  1  1/1322 (0.08%)  1/1297 (0.08%) 
Orthostatic hypotension  1  4/1322 (0.30%)  0/1297 (0.00%) 
Peripheral arterial occlusive disease  1  4/1322 (0.30%)  7/1297 (0.54%) 
Peripheral artery stenosis  1  1/1322 (0.08%)  2/1297 (0.15%) 
Peripheral artery thrombosis  1  1/1322 (0.08%)  0/1297 (0.00%) 
Peripheral ischaemia  1  6/1322 (0.45%)  7/1297 (0.54%) 
Peripheral vascular disorder  1  4/1322 (0.30%)  5/1297 (0.39%) 
Renovascular hypertension  1  1/1322 (0.08%)  0/1297 (0.00%) 
Subclavian vein thrombosis  1  1/1322 (0.08%)  0/1297 (0.00%) 
Thrombosis  1  2/1322 (0.15%)  1/1297 (0.08%) 
Varicose vein  1  0/1322 (0.00%)  1/1297 (0.08%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ranolazine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   665/1322 (50.30%)   531/1297 (40.94%) 
Cardiac disorders     
Angina pectoris  1  161/1322 (12.18%)  156/1297 (12.03%) 
Gastrointestinal disorders     
Constipation  1  167/1322 (12.63%)  71/1297 (5.47%) 
Nausea  1  123/1322 (9.30%)  63/1297 (4.86%) 
General disorders     
Chest pain  1  97/1322 (7.34%)  92/1297 (7.09%) 
Fatigue  1  99/1322 (7.49%)  74/1297 (5.71%) 
Nervous system disorders     
Dizziness  1  240/1322 (18.15%)  119/1297 (9.18%) 
Headache  1  98/1322 (7.41%)  89/1297 (6.86%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  69/1322 (5.22%)  51/1297 (3.93%) 
Dyspnoea  1  89/1322 (6.73%)  89/1297 (6.86%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
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.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01442038     History of Changes
Other Study ID Numbers: GS-US-259-0116
2011-002507-15 ( EudraCT Number )
First Submitted: September 22, 2011
First Posted: September 28, 2011
Results First Submitted: February 9, 2016
Results First Posted: July 15, 2016
Last Update Posted: July 15, 2016