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A Study of Rivaroxaban (JNJ-39039039) on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients (MARINER)

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ClinicalTrials.gov Identifier: NCT02111564
Recruitment Status : Completed
First Posted : April 11, 2014
Results First Posted : November 25, 2019
Last Update Posted : November 25, 2019
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Prevention
Conditions Heart Failure
Respiratory Insufficiency
Stroke Acute
Infectious Diseases
Rheumatic Diseases
Interventions Drug: Rivaroxaban, 10 mg
Drug: Rivaroxaban, 7.5 mg
Drug: Placebo
Enrollment 12024
Recruitment Details 12024 participants were randomized (rivaroxaban-6007;placebo-6017). 5 participants in placebo were excluded(2 invalid consent,3 randomized before Health Authority approval).
Pre-assignment Details Participants were randomized (1:1) to receive rivaroxaban or placebo. In rivaroxaban, participants were treated with rivaroxaban 10 mg or 7.5 mg as per their creatinine clearance level. Data in the participant flow section is reported for study discontinuation from the disposition data.
Arm/Group Title Rivaroxaban 10 mg or 7.5 mg Placebo
Hide Arm/Group Description Participants with a creatinine clearance (CrCl) greater than or equal to (>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from >=30 to less than (<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days. Participants received rivaroxaban matched placebo tablet once daily orally for 45 days.
Period Title: Overall Study
Started 6007 6012
Treated 5982 5980
Completed 5876 5869
Not Completed 131 143
Reason Not Completed
Death             109             120
Lost to Follow-up             2             3
Withdrawal by Subject             20             20
Arm/Group Title Rivaroxaban 10 mg or 7.5 mg Placebo Total
Hide Arm/Group Description Participants with a creatinine clearance (CrCl) greater than or equal to (>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from >=30 to less than (<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days. Participants received rivaroxaban matched placebo tablet once daily orally for 45 days. Total of all reporting groups
Overall Number of Baseline Participants 6007 6012 12019
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6007 participants 6012 participants 12019 participants
69.7  (10.06) 69.7  (10.22) 69.7  (10.14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6007 participants 6012 participants 12019 participants
Female
2877
  47.9%
2858
  47.5%
5735
  47.7%
Male
3130
  52.1%
3154
  52.5%
6284
  52.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6007 participants 6012 participants 12019 participants
Hispanic or Latino
499
   8.3%
482
   8.0%
981
   8.2%
Not Hispanic or Latino
5490
  91.4%
5510
  91.7%
11000
  91.5%
Unknown or Not Reported
18
   0.3%
20
   0.3%
38
   0.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6007 participants 6012 participants 12019 participants
American Indian or Alaska Native
9
   0.1%
5
   0.1%
14
   0.1%
Asian
8
   0.1%
8
   0.1%
16
   0.1%
Native Hawaiian or Other Pacific Islander
128
   2.1%
123
   2.0%
251
   2.1%
Black or African American
71
   1.2%
57
   0.9%
128
   1.1%
White
5782
  96.3%
5808
  96.6%
11590
  96.4%
More than one race
6
   0.1%
9
   0.1%
15
   0.1%
Unknown or Not Reported
3
   0.0%
2
   0.0%
5
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6007 participants 6012 participants 12019 participants
ARGENTINA
120
   2.0%
122
   2.0%
242
   2.0%
AUSTRALIA
45
   0.7%
43
   0.7%
88
   0.7%
AUSTRIA
6
   0.1%
8
   0.1%
14
   0.1%
BELARUS
67
   1.1%
66
   1.1%
133
   1.1%
BOSNIA-HERZEGOVINA
298
   5.0%
299
   5.0%
597
   5.0%
BRAZIL
46
   0.8%
46
   0.8%
92
   0.8%
BULGARIA
714
  11.9%
714
  11.9%
1428
  11.9%
CANADA
21
   0.3%
22
   0.4%
43
   0.4%
COLOMBIA
70
   1.2%
70
   1.2%
140
   1.2%
CROATIA
135
   2.2%
135
   2.2%
270
   2.2%
CZECH REPUBLIC
115
   1.9%
116
   1.9%
231
   1.9%
DENMARK
3
   0.0%
4
   0.1%
7
   0.1%
ESTONIA
5
   0.1%
6
   0.1%
11
   0.1%
GEORGIA
880
  14.6%
882
  14.7%
1762
  14.7%
GERMANY
8
   0.1%
9
   0.1%
17
   0.1%
GREECE
66
   1.1%
65
   1.1%
131
   1.1%
HUNGARY
275
   4.6%
274
   4.6%
549
   4.6%
ISRAEL
55
   0.9%
56
   0.9%
111
   0.9%
ITALY
74
   1.2%
73
   1.2%
147
   1.2%
LATVIA
154
   2.6%
154
   2.6%
308
   2.6%
LITHUANIA
82
   1.4%
82
   1.4%
164
   1.4%
MEXICO
17
   0.3%
15
   0.2%
32
   0.3%
NETHERLANDS
8
   0.1%
9
   0.1%
17
   0.1%
PERU
33
   0.5%
32
   0.5%
65
   0.5%
POLAND
310
   5.2%
309
   5.1%
619
   5.2%
PORTUGAL
6
   0.1%
7
   0.1%
13
   0.1%
PUERTO RICO
0
   0.0%
1
   0.0%
1
   0.0%
REPUBLIC OF MACEDONIA
451
   7.5%
451
   7.5%
902
   7.5%
ROMANIA
162
   2.7%
162
   2.7%
324
   2.7%
RUSSIAN FEDERATION
571
   9.5%
571
   9.5%
1142
   9.5%
SERBIA
305
   5.1%
304
   5.1%
609
   5.1%
SOUTH AFRICA
103
   1.7%
102
   1.7%
205
   1.7%
SPAIN
192
   3.2%
191
   3.2%
383
   3.2%
TURKEY
35
   0.6%
35
   0.6%
70
   0.6%
UKRAINE
426
   7.1%
428
   7.1%
854
   7.1%
UNITED KINGDOM
4
   0.1%
4
   0.1%
8
   0.1%
UNITED STATES
145
   2.4%
145
   2.4%
290
   2.4%
1.Primary Outcome
Title Time From Randomization to First Occurrence of Composite of All Symptomatic Venous Thromboembolism (VTE) and VTE Related Death Adjudicated by Clinical Event Committee (CEC)
Hide Description Symptomatic VTE included lower extremity deep vein thrombosis (DVT) and non-fatal pulmonary embolism (PE). Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45.
Time Frame Up to Day 45
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Arm/Group Title Rivaroxaban 10 mg or 7.5 mg Placebo
Hide Arm/Group Description:
Participants with a creatinine clearance (CrCl) greater than or equal to (>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from >=30 to less than (<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days.
Participants received rivaroxaban matched placebo tablet once daily orally for 45 days.
Overall Number of Participants Analyzed 6007 6012
Measure Type: Number
Unit of Measure: Events per 100 participants in 45 days
0.84 1.11
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rivaroxaban 10 mg or 7.5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.136
Comments [Not Specified]
Method Cox proportional hazards model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.76
Confidence Interval (2-Sided) 95%
0.52 to 1.09
Estimation Comments [Not Specified]
2.Primary Outcome
Title Event Rate Based on Time From Randomization to the First Occurrence of Major Bleeding Adjudicated by CEC
Hide Description A major bleeding event was defined using validated International Society on Thrombosis and Haemostasis (ISTH) bleeding criteria. A major bleeding event was defined as overt bleeding that was associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more, or a transfusion of 2 or more units of packed red blood cells or whole blood, or a critical site defined as intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or a fatal outcome. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or last dose + 2 days.
Time Frame From randomization to 2 days after the last dose (Day 45)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety analysis set included all enrolled participants in the ITT analysis set who received at least 1 dose of study drug.
Arm/Group Title Rivaroxaban 10 mg or 7.5 mg Placebo
Hide Arm/Group Description:
Participants with a creatinine clearance (CrCl) greater than or equal to (>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from >=30 to less than (<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days.
Participants received rivaroxaban matched placebo tablet once daily orally for 45 days.
Overall Number of Participants Analyzed 5982 5980
Measure Type: Number
Unit of Measure: Events per 100 participants in 45 days
0.28 0.15
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rivaroxaban 10 mg or 7.5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.124
Comments [Not Specified]
Method Cox proportional hazards model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.88
Confidence Interval (2-Sided) 95%
0.84 to 4.23
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Event Rate Based on Time From Randomization to First Occurrence of VTE-Related Death Adjudicated by CEC
Hide Description Event rate based on time from randomization to first occurrence of VTE-related death (adjudicated by CEC) was assessed. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45.
Time Frame Up to Day 45
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Arm/Group Title Rivaroxaban 10 mg or 7.5 mg Placebo
Hide Arm/Group Description:
Participants with a creatinine clearance (CrCl) greater than or equal to (>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from >=30 to less than (<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days.
Participants received rivaroxaban matched placebo tablet once daily orally for 45 days.
Overall Number of Participants Analyzed 6007 6012
Measure Type: Number
Unit of Measure: Events per 100 participants in 45 days
0.72 0.77
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rivaroxaban 10 mg or 7.5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.751
Comments [Not Specified]
Method Cox proportional hazards model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.62 to 1.42
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Event Rate Based on Time From Randomization to the First Occurrence of a Symptomatic Venous Thromboembolism Event (VTE) Adjudicated by CEC
Hide Description Event rate based on time from randomization to the first occurrence of a symptomatic VTE (adjudicated by CEC) was assessed. Symptomatic VTE included lower extremity DVT and non-fatal PE. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45.
Time Frame Up to Day 45
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Arm/Group Title Rivaroxaban 10 mg or 7.5 mg Placebo
Hide Arm/Group Description:
Participants with a creatinine clearance (CrCl) greater than or equal to (>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from >=30 to less than (<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days.
Participants received rivaroxaban matched placebo tablet once daily orally for 45 days.
Overall Number of Participants Analyzed 6007 6012
Measure Type: Number
Unit of Measure: Events per 100 participants in 45 days
0.19 0.42
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rivaroxaban 10 mg or 7.5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments [Not Specified]
Method Cox proportional hazards model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.44
Confidence Interval (2-Sided) 95%
0.22 to 0.89
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Event Rate Based on Time From Randomization to the First Occurrence of a Composite of Symptomatic VTE and All-Cause Mortality (ACM) Adjudicated by CEC
Hide Description Event rate based on time from randomization to the first occurrence of a composite of symptomatic VTE and ACM (adjudicated by CEC) was assessed. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45.
Time Frame Up to Day 45
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Arm/Group Title Rivaroxaban 10 mg or 7.5 mg Placebo
Hide Arm/Group Description:
Participants with a creatinine clearance (CrCl) greater than or equal to (>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from >=30 to less than (<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days.
Participants received rivaroxaban matched placebo tablet once daily orally for 45 days.
Overall Number of Participants Analyzed 6007 6012
Measure Type: Number
Unit of Measure: Events per 100 participants in 45 days
1.31 1.80
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rivaroxaban 10 mg or 7.5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.033
Comments [Not Specified]
Method Cox proportional hazards model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.73
Confidence Interval (2-Sided) 95%
0.54 to 0.97
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Event Rate Based on Time From Randomization to the First Occurrence of a Composite of Symptomatic VTE, Myocardial Infarction (MI), Non-Hemorrhagic Stroke, and Cardiovascular (CV) Death Adjudicated by CEC
Hide Description Event rate based on time from randomization to the first occurrence of a composite of symptomatic VTE (lower extremity DVT and non-fatal PE), MI, non-hemorrhagic stroke, and CV death (death due to a known CV cause and death in which a CV cause cannot be ruled out; by this definition, a VTE-related death was considered a CV death) as adjudicated by CEC was reported. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45.
Time Frame Up to Day 45
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Arm/Group Title Rivaroxaban 10 mg or 7.5 mg Placebo
Hide Arm/Group Description:
Participants with a creatinine clearance (CrCl) greater than or equal to (>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from >=30 to less than (<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days.
Participants received rivaroxaban matched placebo tablet once daily orally for 45 days.
Overall Number of Participants Analyzed 6007 6012
Measure Type: Number
Unit of Measure: Events per 100 participants in 45 days
1.58 2.03
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rivaroxaban 10 mg or 7.5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.073
Comments [Not Specified]
Method Cox proportional hazards model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.78
Confidence Interval (2-Sided) 95%
0.60 to 1.02
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Event Rate Based on Time From Randomization to First Occurrence of All-Cause Mortality (ACM) Adjudicated by CEC
Hide Description Event rate based on time from randomization to first occurrence of ACM (adjudicated by CEC) was assessed. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45.
Time Frame Up to Day 45
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Arm/Group Title Rivaroxaban 10 mg or 7.5 mg Placebo
Hide Arm/Group Description:
Participants with a creatinine clearance (CrCl) greater than or equal to (>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from >=30 to less than (<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days.
Participants received rivaroxaban matched placebo tablet once daily orally for 45 days.
Overall Number of Participants Analyzed 6007 6012
Measure Type: Number
Unit of Measure: Events per 100 participants in 45 days
1.19 1.49
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rivaroxaban 10 mg or 7.5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.156
Comments [Not Specified]
Method Cox proportional hazards model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.58 to 1.09
Estimation Comments [Not Specified]
Time Frame Up to 75 days (+/-5 days)
Adverse Event Reporting Description Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
 
Arm/Group Title Rivaroxaban 10 mg or 7.5 mg Placebo
Hide Arm/Group Description Participants with a creatinine clearance (CrCl) greater than or equal to (>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from >=30 to less than (<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days. Participants received rivaroxaban matched placebo tablet once daily orally for 45 days.
All-Cause Mortality
Rivaroxaban 10 mg or 7.5 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   115/6007 (1.91%)   126/6012 (2.10%) 
Hide Serious Adverse Events
Rivaroxaban 10 mg or 7.5 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   475/6007 (7.91%)   493/6012 (8.20%) 
Blood and lymphatic system disorders     
Anaemia * 1  3/6007 (0.05%)  0/6012 (0.00%) 
Autoimmune Haemolytic Anaemia * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Haemorrhagic Anaemia * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Iron Deficiency Anaemia * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Thrombocytopenia * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Cardiac disorders     
Acute Left Ventricular Failure * 1  1/6007 (0.02%)  1/6012 (0.02%) 
Angina Pectoris * 1  3/6007 (0.05%)  1/6012 (0.02%) 
Aortic Valve Incompetence * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Atrial Fibrillation * 1  13/6007 (0.22%)  10/6012 (0.17%) 
Atrial Flutter * 1  3/6007 (0.05%)  6/6012 (0.10%) 
Atrioventricular Block Complete * 1  4/6007 (0.07%)  1/6012 (0.02%) 
Atrioventricular Block Second Degree * 1  1/6007 (0.02%)  1/6012 (0.02%) 
Bradyarrhythmia * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Bradycardia * 1  0/6007 (0.00%)  2/6012 (0.03%) 
Cardiac Arrest * 1  5/6007 (0.08%)  5/6012 (0.08%) 
Cardiac Asthma * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Cardiac Failure * 1  51/6007 (0.85%)  62/6012 (1.03%) 
Cardiac Failure Acute * 1  14/6007 (0.23%)  14/6012 (0.23%) 
Cardiac Failure Chronic * 1  13/6007 (0.22%)  8/6012 (0.13%) 
Cardiac Failure Congestive * 1  24/6007 (0.40%)  25/6012 (0.42%) 
Cardiac Valve Disease * 1  1/6007 (0.02%)  1/6012 (0.02%) 
Cardiac Ventricular Thrombosis * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Cardio-Respiratory Arrest * 1  5/6007 (0.08%)  2/6012 (0.03%) 
Cardiogenic Shock * 1  4/6007 (0.07%)  2/6012 (0.03%) 
Cardiomyopathy * 1  2/6007 (0.03%)  1/6012 (0.02%) 
Cardiomyopathy Acute * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Cardiopulmonary Failure * 1  4/6007 (0.07%)  4/6012 (0.07%) 
Congestive Cardiomyopathy * 1  1/6007 (0.02%)  2/6012 (0.03%) 
Cor Pulmonale * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Coronary Artery Disease * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Coronary Artery Stenosis * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Diastolic Dysfunction * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Hypertensive Heart Disease * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Interventricular Septum Rupture * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Ischaemic Cardiomyopathy * 1  1/6007 (0.02%)  1/6012 (0.02%) 
Left Ventricular Failure * 1  4/6007 (0.07%)  2/6012 (0.03%) 
Mitral Valve Incompetence * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Myocardial Fibrosis * 1  2/6007 (0.03%)  0/6012 (0.00%) 
Myocardial Ischaemia * 1  1/6007 (0.02%)  1/6012 (0.02%) 
Myocarditis * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Nodal Rhythm * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Pericarditis * 1  1/6007 (0.02%)  1/6012 (0.02%) 
Right Ventricular Failure * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Sinus Bradycardia * 1  1/6007 (0.02%)  1/6012 (0.02%) 
Sinus Node Dysfunction * 1  2/6007 (0.03%)  1/6012 (0.02%) 
Supraventricular Tachycardia * 1  1/6007 (0.02%)  3/6012 (0.05%) 
Tachycardia * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Ventricular Extrasystoles * 1  0/6007 (0.00%)  2/6012 (0.03%) 
Ventricular Tachycardia * 1  3/6007 (0.05%)  0/6012 (0.00%) 
Ear and labyrinth disorders     
Motion Sickness * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Vertigo * 1  2/6007 (0.03%)  0/6012 (0.00%) 
Vertigo Positional * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Eye disorders     
Conjunctival Oedema * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Exophthalmos * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Retinal Artery Occlusion * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Gastrointestinal disorders     
Abdominal Incarcerated Hernia * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Abdominal Pain * 1  1/6007 (0.02%)  1/6012 (0.02%) 
Acute Abdomen * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Ascites * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Chronic Gastritis * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Colitis Ischaemic * 1  1/6007 (0.02%)  1/6012 (0.02%) 
Diarrhoea * 1  3/6007 (0.05%)  0/6012 (0.00%) 
Duodenal Ulcer * 1  2/6007 (0.03%)  2/6012 (0.03%) 
Dyspepsia * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Dysphagia * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Enterocolitis * 1  2/6007 (0.03%)  2/6012 (0.03%) 
Enterocolitis Haemorrhagic * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Enterovesical Fistula * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Gastric Polyps * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Gastric Ulcer * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Gastritis * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Gastrooesophageal Reflux Disease * 1  1/6007 (0.02%)  1/6012 (0.02%) 
Haemorrhoids * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Ileus * 1  1/6007 (0.02%)  1/6012 (0.02%) 
Inguinal Hernia * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Intestinal Ischaemia * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Pancreatic Disorder * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Pancreatitis * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Pancreatitis Acute * 1  2/6007 (0.03%)  2/6012 (0.03%) 
Peptic Ulcer * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Peptic Ulcer Haemorrhage * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Peptic Ulcer Perforation * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Rectal Polyp * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Small Intestinal Obstruction * 1  0/6007 (0.00%)  2/6012 (0.03%) 
Subileus * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Vomiting * 1  0/6007 (0.00%)  1/6012 (0.02%) 
General disorders     
Asthenia * 1  1/6007 (0.02%)  1/6012 (0.02%) 
Chest Pain * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Death * 1  25/6007 (0.42%)  30/6012 (0.50%) 
Fatigue * 1  1/6007 (0.02%)  2/6012 (0.03%) 
Multiple Organ Dysfunction Syndrome * 1  1/6007 (0.02%)  2/6012 (0.03%) 
Oedema Peripheral * 1  1/6007 (0.02%)  1/6012 (0.02%) 
Peripheral Swelling * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Pyrexia * 1  0/6007 (0.00%)  3/6012 (0.05%) 
Sudden Cardiac Death * 1  1/6007 (0.02%)  2/6012 (0.03%) 
Systemic Inflammatory Response Syndrome * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Hepatobiliary disorders     
Bile Duct Obstruction * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Bile Duct Stone * 1  0/6007 (0.00%)  2/6012 (0.03%) 
Cholecystitis * 1  2/6007 (0.03%)  3/6012 (0.05%) 
Cholecystitis Acute * 1  2/6007 (0.03%)  0/6012 (0.00%) 
Cholecystitis Chronic * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Cholelithiasis * 1  2/6007 (0.03%)  2/6012 (0.03%) 
Hepatic Lesion * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Immune system disorders     
Anaphylactic Reaction * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Infections and infestations     
Abdominal Abscess * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Abscess Limb * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Anal Abscess * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Breast Cellulitis * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Bronchitis * 1  5/6007 (0.08%)  3/6012 (0.05%) 
Bronchopulmonary Aspergillosis * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Cellulitis * 1  11/6007 (0.18%)  10/6012 (0.17%) 
Clostridium Difficile Colitis * 1  2/6007 (0.03%)  1/6012 (0.02%) 
Clostridium Difficile Infection * 1  1/6007 (0.02%)  1/6012 (0.02%) 
Diabetic Foot Infection * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Diverticulitis * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Empyema * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Endocarditis * 1  0/6007 (0.00%)  2/6012 (0.03%) 
Endocarditis Bacterial * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Endophthalmitis * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Endotoxic Shock * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Erysipelas * 1  3/6007 (0.05%)  4/6012 (0.07%) 
Fungal Oesophagitis * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Fungal Skin Infection * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Gastroenteritis * 1  2/6007 (0.03%)  3/6012 (0.05%) 
Gastroenteritis Salmonella * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Gastroenteritis Viral * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Haematoma Infection * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Helicobacter Infection * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Infection * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Infectious Colitis * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Infectious Pleural Effusion * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Infective Exacerbation of Bronchiectasis * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Infective Exacerbation of Chronic Obstructive Airways Disease * 1  1/6007 (0.02%)  4/6012 (0.07%) 
Infective Spondylitis * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Influenza * 1  1/6007 (0.02%)  1/6012 (0.02%) 
Injection Site Abscess * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Intervertebral Discitis * 1  0/6007 (0.00%)  2/6012 (0.03%) 
Lower Respiratory Tract Infection * 1  2/6007 (0.03%)  1/6012 (0.02%) 
Lung Abscess * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Lung Infection * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Mediastinitis * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Osteomyelitis * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Parotitis * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Pneumonia * 1  58/6007 (0.97%)  48/6012 (0.80%) 
Pneumonia Bacterial * 1  2/6007 (0.03%)  4/6012 (0.07%) 
Pneumonia Pseudomonal * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Pneumonia Staphylococcal * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Postoperative Wound Infection * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Pulmonary Sepsis * 1  0/6007 (0.00%)  2/6012 (0.03%) 
Pulmonary Tuberculosis * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Pyelonephritis * 1  0/6007 (0.00%)  2/6012 (0.03%) 
Pyelonephritis Chronic * 1  2/6007 (0.03%)  1/6012 (0.02%) 
Pyoderma * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Respiratory Tract Infection * 1  3/6007 (0.05%)  3/6012 (0.05%) 
Sepsis * 1  4/6007 (0.07%)  3/6012 (0.05%) 
Septic Shock * 1  1/6007 (0.02%)  4/6012 (0.07%) 
Sinusitis * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Soft Tissue Infection * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Splenic Abscess * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Staphylococcal Bacteraemia * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Staphylococcal Sepsis * 1  2/6007 (0.03%)  0/6012 (0.00%) 
Systemic Infection * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Tracheobronchitis * 1  2/6007 (0.03%)  0/6012 (0.00%) 
Tuberculous Pleurisy * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Upper Respiratory Tract Infection * 1  2/6007 (0.03%)  1/6012 (0.02%) 
Urinary Tract Infection * 1  11/6007 (0.18%)  11/6012 (0.18%) 
Urinary Tract Infection Bacterial * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Urosepsis * 1  0/6007 (0.00%)  4/6012 (0.07%) 
Viral Infection * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Wound Infection * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Wound Infection Staphylococcal * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Injury, poisoning and procedural complications     
Accidental Overdose * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Cervical Vertebral Fracture * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Fall * 1  1/6007 (0.02%)  1/6012 (0.02%) 
Femoral Neck Fracture * 1  0/6007 (0.00%)  2/6012 (0.03%) 
Femur Fracture * 1  0/6007 (0.00%)  3/6012 (0.05%) 
Head Injury * 1  1/6007 (0.02%)  2/6012 (0.03%) 
Hip Fracture * 1  1/6007 (0.02%)  2/6012 (0.03%) 
Humerus Fracture * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Intestinal Anastomosis Complication * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Laceration * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Ligament Rupture * 1  1/6007 (0.02%)  1/6012 (0.02%) 
Lower Limb Fracture * 1  1/6007 (0.02%)  1/6012 (0.02%) 
Lumbar Vertebral Fracture * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Multiple Injuries * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Nerve Injury * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Procedural Pneumothorax * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Rib Fracture * 1  1/6007 (0.02%)  1/6012 (0.02%) 
Soft Tissue Injury * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Tendon Injury * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Toxicity to Various Agents * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Traumatic Lung Injury * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Twiddler's Syndrome * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Investigations     
Aspiration Bronchial * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Body Temperature Increased * 1  0/6007 (0.00%)  2/6012 (0.03%) 
Cardiac Output Decreased * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Myocardial Necrosis Marker Increased * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Metabolism and nutrition disorders     
Dehydration * 1  2/6007 (0.03%)  3/6012 (0.05%) 
Diabetes Mellitus * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Diabetes Mellitus Inadequate Control * 1  1/6007 (0.02%)  1/6012 (0.02%) 
Diabetic Metabolic Decompensation * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Failure to Thrive * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Fluid Overload * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Gout * 1  1/6007 (0.02%)  2/6012 (0.03%) 
Hyperglycaemia * 1  2/6007 (0.03%)  0/6012 (0.00%) 
Hyperkalaemia * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Hypoalbuminaemia * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Hypocalcaemia * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Hypoglycaemia * 1  3/6007 (0.05%)  5/6012 (0.08%) 
Hypokalaemia * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Hyponatraemia * 1  1/6007 (0.02%)  1/6012 (0.02%) 
Overweight * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Type 2 Diabetes Mellitus * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Vitamin B12 Deficiency * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthritis * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Back Pain * 1  1/6007 (0.02%)  1/6012 (0.02%) 
Bursitis * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Compartment Syndrome * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Musculoskeletal Chest Pain * 1  2/6007 (0.03%)  0/6012 (0.00%) 
Osteoarthritis * 1  2/6007 (0.03%)  1/6012 (0.02%) 
Rheumatoid Arthritis * 1  1/6007 (0.02%)  3/6012 (0.05%) 
Vertebral Lesion * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute Leukaemia * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Adenocarcinoma * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Adenocarcinoma of Colon * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Bladder Cancer Recurrent * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Bladder Neoplasm * 1  0/6007 (0.00%)  2/6012 (0.03%) 
Breast Cancer * 1  1/6007 (0.02%)  1/6012 (0.02%) 
Breast Neoplasm * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Colon Cancer Metastatic * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Gastric Cancer * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Hepatic Cancer Metastatic * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Invasive Ductal Breast Carcinoma * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Lung Cancer Metastatic * 1  0/6007 (0.00%)  2/6012 (0.03%) 
Lung Infiltration Malignant * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Lung Neoplasm * 1  2/6007 (0.03%)  1/6012 (0.02%) 
Lung Neoplasm Malignant * 1  0/6007 (0.00%)  5/6012 (0.08%) 
Malignant Neoplasm of Unknown Primary Site * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Malignant Pleural Effusion * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Mediastinum Neoplasm * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Meningioma * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Metastatic Neoplasm * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Non-Hodgkin's Lymphoma * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Non-Small Cell Lung Cancer * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Ovarian Cancer * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Plasma Cell Myeloma * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Rectal Cancer * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Rectal Neoplasm * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Rectosigmoid Cancer * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Renal Neoplasm * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Squamous Cell Carcinoma of Lung * 1  1/6007 (0.02%)  1/6012 (0.02%) 
Nervous system disorders     
Aphasia * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Carotid Artery Occlusion * 1  1/6007 (0.02%)  1/6012 (0.02%) 
Carotid Artery Stenosis * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Craniocervical Syndrome * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Demyelinating Polyneuropathy * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Encephalopathy * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Epilepsy * 1  1/6007 (0.02%)  1/6012 (0.02%) 
Facial Paralysis * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Headache * 1  2/6007 (0.03%)  0/6012 (0.00%) 
Hypoglycaemic Coma * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Hypoglycaemic Encephalopathy * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Ischaemic Stroke * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Lumbar Radiculopathy * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Orthostatic Intolerance * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Presyncope * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Sciatica * 1  1/6007 (0.02%)  1/6012 (0.02%) 
Seizure * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Syncope * 1  6/6007 (0.10%)  5/6012 (0.08%) 
Vascular Encephalopathy * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Vertebral Artery Stenosis * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Vertigo CNS Origin * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Product Issues     
Device Dislocation * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Device Failure * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Device Occlusion * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Psychiatric disorders     
Anxiety * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Conversion Disorder * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Panic Attack * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Renal and urinary disorders     
Acute Kidney Injury * 1  7/6007 (0.12%)  8/6012 (0.13%) 
Chronic Kidney Disease * 1  1/6007 (0.02%)  2/6012 (0.03%) 
Ketonuria * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Nephritis * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Nephrolithiasis * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Nephrotic Syndrome * 1  2/6007 (0.03%)  0/6012 (0.00%) 
Renal Failure * 1  3/6007 (0.05%)  3/6012 (0.05%) 
Renal Impairment * 1  1/6007 (0.02%)  2/6012 (0.03%) 
Urinary Retention * 1  3/6007 (0.05%)  0/6012 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute Pulmonary Oedema * 1  4/6007 (0.07%)  1/6012 (0.02%) 
Acute Respiratory Failure * 1  7/6007 (0.12%)  9/6012 (0.15%) 
Asthma * 1  8/6007 (0.13%)  3/6012 (0.05%) 
Bronchiectasis * 1  1/6007 (0.02%)  2/6012 (0.03%) 
Bronchitis Chronic * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Bronchospasm * 1  1/6007 (0.02%)  3/6012 (0.05%) 
Chronic Obstructive Pulmonary Disease * 1  81/6007 (1.35%)  77/6012 (1.28%) 
Chronic Respiratory Failure * 1  4/6007 (0.07%)  0/6012 (0.00%) 
Dyspnoea * 1  1/6007 (0.02%)  5/6012 (0.08%) 
Hydrothorax * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Interstitial Lung Disease * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Lupus Pleurisy * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Pickwickian Syndrome * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Pleural Effusion * 1  2/6007 (0.03%)  3/6012 (0.05%) 
Pneumonia Aspiration * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Pneumothorax * 1  3/6007 (0.05%)  0/6012 (0.00%) 
Pneumothorax Spontaneous * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Pulmonary Arterial Hypertension * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Pulmonary Congestion * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Pulmonary Fibrosis * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Pulmonary Mass * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Pulmonary Oedema * 1  1/6007 (0.02%)  4/6012 (0.07%) 
Pulmonary Pneumatocele * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Respiratory Distress * 1  1/6007 (0.02%)  1/6012 (0.02%) 
Respiratory Failure * 1  9/6007 (0.15%)  8/6012 (0.13%) 
Skin and subcutaneous tissue disorders     
Angioedema * 1  2/6007 (0.03%)  0/6012 (0.00%) 
Dermatitis Allergic * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Diabetic Foot * 1  2/6007 (0.03%)  1/6012 (0.02%) 
Rash * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Skin Necrosis * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Skin Ulcer * 1  1/6007 (0.02%)  2/6012 (0.03%) 
Vasculitic Ulcer * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Social circumstances     
Bereavement * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Immobile * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Surgical and medical procedures     
Hospitalisation * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Vascular disorders     
Aortic Dissection * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Aortic Stenosis * 1  2/6007 (0.03%)  1/6012 (0.02%) 
Arterial Stenosis * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Distributive Shock * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Hypertension * 1  1/6007 (0.02%)  2/6012 (0.03%) 
Hypertensive Crisis * 1  0/6007 (0.00%)  3/6012 (0.05%) 
Hypotension * 1  5/6007 (0.08%)  3/6012 (0.05%) 
Peripheral Arterial Occlusive Disease * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Peripheral Artery Occlusion * 1  1/6007 (0.02%)  0/6012 (0.00%) 
Peripheral Artery Thrombosis * 1  0/6007 (0.00%)  2/6012 (0.03%) 
Peripheral Ischaemia * 1  0/6007 (0.00%)  1/6012 (0.02%) 
Post Thrombotic Syndrome * 1  1/6007 (0.02%)  0/6012 (0.00%) 
1
Term from vocabulary, MedDRA Version 20.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Rivaroxaban 10 mg or 7.5 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   250/6007 (4.16%)   280/6012 (4.66%) 
Gastrointestinal disorders     
Diarrhoea * 1  69/6007 (1.15%)  52/6012 (0.86%) 
Nervous system disorders     
Headache * 1  114/6007 (1.90%)  147/6012 (2.45%) 
Vascular disorders     
Hypertension * 1  75/6007 (1.25%)  93/6012 (1.55%) 
1
Term from vocabulary, MedDRA Version 20.1
*
Indicates events were collected by non-systematic assessment
Study was stopped prior to achieving preplanned 161 participants with primary outcome events. Other limitations included how VTE-related death was defined and participants with moderate renal impairment may have been under-dosed.
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.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Leader
Organization: Janssen Research & Development, LLC
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02111564    
Other Study ID Numbers: CR103834
2014-000305-13 ( EudraCT Number )
RIVAROXDVT3002 ( Other Identifier: Janssen Research & Development, LLC )
First Submitted: March 31, 2014
First Posted: April 11, 2014
Results First Submitted: November 5, 2019
Results First Posted: November 25, 2019
Last Update Posted: November 25, 2019