Trial Outcomes & Findings for A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction or Stroke in Participants With Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure (NCT NCT01877915)
NCT ID: NCT01877915
Last Updated: 2019-05-10
Results Overview
Event Rate of all-cause mortality (ACM), MI, or stroke were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 patient \[pt\]-year \[yr\]) = 100\*n/(total risk exposure), where n is the number of events.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
5081 participants
Primary outcome timeframe
Up to Global treatment end date (approximately 54 months)
Results posted on
2019-05-10
Participant Flow
A total of 3 participants randomized twice were only counted once in the ITT analysis set (comprised of 5,022 participants).
Participant milestones
| Measure |
Rivaroxaban
Participants received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
|
Placebo
Participants received matching placebo orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
|
|---|---|---|
|
Overall Study
STARTED
|
2507
|
2515
|
|
Overall Study
COMPLETED
|
2453
|
2447
|
|
Overall Study
NOT COMPLETED
|
54
|
68
|
Reasons for withdrawal
| Measure |
Rivaroxaban
Participants received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
|
Placebo
Participants received matching placebo orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
9
|
|
Overall Study
Withdrawal by Subject
|
42
|
55
|
|
Overall Study
Other
|
2
|
4
|
Baseline Characteristics
A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction or Stroke in Participants With Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure
Baseline characteristics by cohort
| Measure |
Rivaroxaban
n=2507 Participants
Participants received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
|
Placebo
n=2515 Participants
Participants received matching placebo orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
|
Total
n=5022 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Region of Enrollment
GERMANY
|
32 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
64 Participants
n=27 Participants
|
|
Age, Continuous
|
66.5 years
STANDARD_DEVIATION 10.07 • n=93 Participants
|
66.3 years
STANDARD_DEVIATION 10.27 • n=4 Participants
|
66.4 years
STANDARD_DEVIATION 10.17 • n=27 Participants
|
|
Sex: Female, Male
Female
|
551 Participants
n=93 Participants
|
599 Participants
n=4 Participants
|
1150 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
1956 Participants
n=93 Participants
|
1916 Participants
n=4 Participants
|
3872 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
309 Participants
n=93 Participants
|
300 Participants
n=4 Participants
|
609 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2186 Participants
n=93 Participants
|
2203 Participants
n=4 Participants
|
4389 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
11 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
362 Participants
n=93 Participants
|
365 Participants
n=4 Participants
|
727 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
65 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
2063 Participants
n=93 Participants
|
2065 Participants
n=4 Participants
|
4128 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
36 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
70 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
362 Participants
n=93 Participants
|
365 Participants
n=4 Participants
|
727 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
29 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
65 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
59 Participants
n=93 Participants
|
56 Participants
n=4 Participants
|
115 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White Hispanic or Latino
|
258 Participants
n=93 Participants
|
251 Participants
n=4 Participants
|
509 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
1799 Participants
n=93 Participants
|
1807 Participants
n=4 Participants
|
3606 Participants
n=27 Participants
|
|
Region of Enrollment
ARGENTINA
|
76 Participants
n=93 Participants
|
76 Participants
n=4 Participants
|
152 Participants
n=27 Participants
|
|
Region of Enrollment
AUSTRALIA
|
7 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Region of Enrollment
BRAZIL
|
80 Participants
n=93 Participants
|
80 Participants
n=4 Participants
|
160 Participants
n=27 Participants
|
|
Region of Enrollment
BULGARIA
|
314 Participants
n=93 Participants
|
314 Participants
n=4 Participants
|
628 Participants
n=27 Participants
|
|
Region of Enrollment
CANADA
|
14 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Region of Enrollment
CHINA
|
186 Participants
n=93 Participants
|
186 Participants
n=4 Participants
|
372 Participants
n=27 Participants
|
|
Region of Enrollment
CZECH REPUBLIC
|
35 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
69 Participants
n=27 Participants
|
|
Region of Enrollment
FRANCE
|
10 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Region of Enrollment
DENMARK
|
9 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Region of Enrollment
GREECE
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Region of Enrollment
HUNGARY
|
69 Participants
n=93 Participants
|
69 Participants
n=4 Participants
|
138 Participants
n=27 Participants
|
|
Region of Enrollment
ITALY
|
35 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
71 Participants
n=27 Participants
|
|
Region of Enrollment
JAPAN
|
133 Participants
n=93 Participants
|
132 Participants
n=4 Participants
|
265 Participants
n=27 Participants
|
|
Region of Enrollment
LATVIA
|
12 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Region of Enrollment
LITHUANIA
|
17 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
|
Region of Enrollment
MALAYSIA
|
17 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Region of Enrollment
MEXICO
|
73 Participants
n=93 Participants
|
73 Participants
n=4 Participants
|
146 Participants
n=27 Participants
|
|
Region of Enrollment
NETHERLANDS
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Region of Enrollment
POLAND
|
288 Participants
n=93 Participants
|
290 Participants
n=4 Participants
|
578 Participants
n=27 Participants
|
|
Region of Enrollment
PORTUGAL
|
20 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
|
Region of Enrollment
ROMANIA
|
200 Participants
n=93 Participants
|
198 Participants
n=4 Participants
|
398 Participants
n=27 Participants
|
|
Region of Enrollment
RUSSIAN FEDERATION
|
274 Participants
n=93 Participants
|
276 Participants
n=4 Participants
|
550 Participants
n=27 Participants
|
|
Region of Enrollment
SLOVAKIA
|
41 Participants
n=93 Participants
|
41 Participants
n=4 Participants
|
82 Participants
n=27 Participants
|
|
Region of Enrollment
SOUTH AFRICA
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Region of Enrollment
SOUTH KOREA
|
24 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
|
Region of Enrollment
SPAIN
|
89 Participants
n=93 Participants
|
89 Participants
n=4 Participants
|
178 Participants
n=27 Participants
|
|
Region of Enrollment
SWEDEN
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Region of Enrollment
TURKEY
|
96 Participants
n=93 Participants
|
96 Participants
n=4 Participants
|
192 Participants
n=27 Participants
|
|
Region of Enrollment
UKRAINE
|
264 Participants
n=93 Participants
|
265 Participants
n=4 Participants
|
529 Participants
n=27 Participants
|
|
Region of Enrollment
UNITED KINGDOM
|
13 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Region of Enrollment
UNITED STATES
|
60 Participants
n=93 Participants
|
61 Participants
n=4 Participants
|
121 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Up to Global treatment end date (approximately 54 months)Population: Intent-to-Treat analysis set included all randomized unique participants who signed a valid informed consent. Participants were analyzed according to the treatment group assigned, irrespective of the actual treatment received.
Event Rate of all-cause mortality (ACM), MI, or stroke were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 patient \[pt\]-year \[yr\]) = 100\*n/(total risk exposure), where n is the number of events.
Outcome measures
| Measure |
Rivaroxaban
n=2507 Participants
Participants received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
|
Placebo
n=2515 Participants
Participants received matching placebo orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
|
|---|---|---|
|
Event Rate of All-Cause Mortality, Myocardial Infarction (MI), or Stroke
|
13.44 Event rate per 100 patient-year
|
14.27 Event rate per 100 patient-year
|
PRIMARY outcome
Timeframe: Up to 227 WeeksPopulation: Safety Analysis Set included all intent-to-treat participants who received at least one dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure.
Event rate of either fatal bleeding or bleeding into critical space with potential for permanent disability were assessed. Fatal bleeding event was death within 7 days after a bleeding event which required hospitalization or met International Society on Thrombosis and Haemostasis(ISTH) major bleeding definition criteria. Fatal bleeding events included those met criteria in 3 categories: 1: Any ISTH major bleeding event consider primary cause of death by investigator; 2: Any ISTH major bleeding event not considered to be primary cause of death by investigator but resulted in death within 7 days;3: Any bleeding event resulted in hospital stay and death within 7 days. Bleeding into critical space with potential for permanent disability included 7 critical spaces: intracranial, intraspinal, intraocular. Event rate estimated based on time to first occurrence of event were reported in the study. Event Rate / (100 pt-yr) = 100\*n/(total risk exposure), where n is the number of events.
Outcome measures
| Measure |
Rivaroxaban
n=2499 Participants
Participants received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
|
Placebo
n=2509 Participants
Participants received matching placebo orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
|
|---|---|---|
|
Event Rate of Either Fatal Bleeding or Bleeding Into a Critical Space With Potential for Permanent Disability
Fatal Bleeding
|
0.22 Event rate per 100 patient-year
|
0.22 Event rate per 100 patient-year
|
|
Event Rate of Either Fatal Bleeding or Bleeding Into a Critical Space With Potential for Permanent Disability
Critical Space Bleeding with Permanent Disability
|
0.32 Event rate per 100 patient-year
|
0.48 Event rate per 100 patient-year
|
SECONDARY outcome
Timeframe: Up to Global treatment end date (approximately 54 months)Population: Intent-to-Treat analysis set included all randomized unique participants who signed a valid informed consent. Participants were analyzed according to the treatment group assigned, irrespective of the actual treatment received.
Event rate of cardio vascular (CV) death or re-hospitalization for worsening of heart failure were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100\*n/(total risk exposure), where n is the number of events.
Outcome measures
| Measure |
Rivaroxaban
n=2507 Participants
Participants received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
|
Placebo
n=2515 Participants
Participants received matching placebo orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
|
|---|---|---|
|
Event Rate of Cardio Vascular Death or Re-Hospitalization for Worsening of Heart Failure (RHHF)
|
23.32 Event rate per 100 patient-year
|
23.46 Event rate per 100 patient-year
|
SECONDARY outcome
Timeframe: Up to Global treatment end date (approximately 54 months)Population: Intent-to-Treat analysis set included all randomized unique participants who signed a valid informed consent. Participants were analyzed according to the treatment group assigned, irrespective of the actual treatment received.
Event rate of cardio vascular death were assessed. CV death included deaths due to spontaneous bleeding, MI, stroke, worsening HF and arrhythmias, death due to CV procedures and sudden death. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100\*n/(total risk exposure), where n is the number of events.
Outcome measures
| Measure |
Rivaroxaban
n=2507 Participants
Participants received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
|
Placebo
n=2515 Participants
Participants received matching placebo orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
|
|---|---|---|
|
Event Rate of Cardio Vascular Death
|
9.46 Event rate per 100 patient-year
|
9.96 Event rate per 100 patient-year
|
SECONDARY outcome
Timeframe: Up to Global treatment end date (approximately 54 months)Population: Intent-to-Treat analysis set included all randomized unique participants who signed a valid informed consent. Participants were analyzed according to the treatment group assigned, irrespective of the actual treatment received.
Event rate of re-hospitalization for worsening of heart failure were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100\*n/(total risk exposure), where n is the number of events.
Outcome measures
| Measure |
Rivaroxaban
n=2507 Participants
Participants received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
|
Placebo
n=2515 Participants
Participants received matching placebo orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
|
|---|---|---|
|
Event Rate of Re-Hospitalization for Worsening of Heart Failure
|
17.24 Event rate per 100 patient-year
|
17.45 Event rate per 100 patient-year
|
SECONDARY outcome
Timeframe: Up to Global treatment end date (approximately 54 months)Population: Intent-to-Treat analysis set included all randomized unique participants who signed a valid informed consent. Participants were analyzed according to the treatment group assigned, irrespective of the actual treatment received.
Event rate due to cardio vascular events were assessed. Hospitalization for a CV Event required that participants be hospitalized (in-patient or emergency department) for greater than 24 hours and must have met the following criterion:Discharge summary with primary reason for admission listed as CV in nature (example, bleeding, arrhythmia, ACS, MI) other than HF which was captured in the HF re-hospitalization. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100\*n/(total risk exposure), where n is the number of events.
Outcome measures
| Measure |
Rivaroxaban
n=2507 Participants
Participants received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
|
Placebo
n=2515 Participants
Participants received matching placebo orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
|
|---|---|---|
|
Event Rate of Re-Hospitalization for Cardio Vascular Events (RHCV)
|
13.30 Event rate per 100 patient-year
|
14.04 Event rate per 100 patient-year
|
SECONDARY outcome
Timeframe: Up to Global treatment end date (approximately 54 months)Population: Intent-to-Treat analysis set included all randomized unique participants who signed a valid informed consent. Participants were analyzed according to the treatment group assigned, irrespective of the actual treatment received.
Event rate of all-Cause Mortality (ACM) or re-Hospitalization for worsening heart failure were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100\*n/(total risk exposure), where n is the number of events.
Outcome measures
| Measure |
Rivaroxaban
n=2507 Participants
Participants received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
|
Placebo
n=2515 Participants
Participants received matching placebo orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
|
|---|---|---|
|
Event Rate of All-Cause Mortality (ACM) or Re-Hospitalization for Worsening Heart Failure
|
24.84 Event rate per 100 patient-year
|
24.57 Event rate per 100 patient-year
|
SECONDARY outcome
Timeframe: Up to 227 WeeksPopulation: Safety Analysis Set included all intent-to-treat participants who received at least one dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure.
Event rate of bleeding events and required Hospitalization were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100\*n/(total risk exposure), where n is the number of events.
Outcome measures
| Measure |
Rivaroxaban
n=2499 Participants
Participants received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
|
Placebo
n=2509 Participants
Participants received matching placebo orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
|
|---|---|---|
|
Event Rate of Bleeding Events That Requiring Hospitalization
|
1.52 Event rate per 100 patient-year
|
1.16 Event rate per 100 patient-year
|
SECONDARY outcome
Timeframe: Up to 227 WeeksPopulation: Safety Analysis Set included all intent-to-treat participants who received at least one dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure.
Event rate of ISTH major bleeding event were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100\*n/(total risk exposure), where n is the number of events.
Outcome measures
| Measure |
Rivaroxaban
n=2499 Participants
Participants received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
|
Placebo
n=2509 Participants
Participants received matching placebo orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
|
|---|---|---|
|
Event Rate of International Society on Thrombosis and Haemostasis (ISTH) Major Bleeding Event
|
2.04 Event rate per 100 patient-year
|
1.21 Event rate per 100 patient-year
|
Adverse Events
Placebo
Serious events: 451 serious events
Other events: 60 other events
Deaths: 571 deaths
Rivaroxaban
Serious events: 479 serious events
Other events: 53 other events
Deaths: 565 deaths
Serious adverse events
| Measure |
Placebo
n=2515 participants at risk
Participants received matching placebo orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
|
Rivaroxaban
n=2507 participants at risk
Participants received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
|
|---|---|---|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.12%
3/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Cardiac disorders
Cardiac Failure
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Cardiac disorders
Cardiac Ventricular Thrombosis
|
0.04%
1/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Cardiac disorders
Cardiogenic Shock
|
0.08%
2/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Blood and lymphatic system disorders
Anaemia
|
0.28%
7/2515 • Up to 54 Months
|
0.48%
12/2507 • Up to 54 Months
|
|
Blood and lymphatic system disorders
Anaemia Vitamin B12 Deficiency
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Blood and lymphatic system disorders
Aplastic Anaemia
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Cardiac disorders
Cardiorenal Syndrome
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Cardiac disorders
Myocarditis
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Cardiac disorders
Palpitations
|
0.04%
1/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Congenital, familial and genetic disorders
Arteriovenous Malformation
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Congenital, familial and genetic disorders
Buried Penis Syndrome
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Ear and labyrinth disorders
Vertigo
|
0.08%
2/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Ear and labyrinth disorders
Vertigo Positional
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Endocrine disorders
Basedow's Disease
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Endocrine disorders
Hypothyroidism
|
0.04%
1/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Eye disorders
Cataract
|
0.08%
2/2515 • Up to 54 Months
|
0.28%
7/2507 • Up to 54 Months
|
|
Eye disorders
Cataract Nuclear
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Eye disorders
Diabetic Retinopathy
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Eye disorders
Macular Hole
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Eye disorders
Ophthalmoplegia
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Eye disorders
Retinopathy Hypertensive
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Eye disorders
Subretinal Fibrosis
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Eye disorders
Visual Acuity Reduced
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Abdominal Adhesions
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.28%
7/2515 • Up to 54 Months
|
0.24%
6/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.04%
1/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Abdominal Tenderness
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Anal Fissure
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Ascites
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Chronic Gastritis
|
0.04%
1/2515 • Up to 54 Months
|
0.12%
3/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Coeliac Disease
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Constipation
|
0.04%
1/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Dental Caries
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.08%
2/2515 • Up to 54 Months
|
0.16%
4/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Diverticulum Intestinal
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Duodenal Obstruction
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.12%
3/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Dysphagia
|
0.04%
1/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Erosive Duodenitis
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Food Poisoning
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.12%
3/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Gastritis
|
0.16%
4/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Gastritis Erosive
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Gastrointestinal Angiodysplasia
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Gastrointestinal Disorder
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Gastrointestinal Necrosis
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.04%
1/2515 • Up to 54 Months
|
0.12%
3/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Gastrooesophageal Sphincter Insufficiency
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Hernial Eventration
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Ileus
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Ileus Paralytic
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Incarcerated Inguinal Hernia
|
0.08%
2/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Incarcerated Umbilical Hernia
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Inflammatory Bowel Disease
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.36%
9/2515 • Up to 54 Months
|
0.28%
7/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Intestinal Infarction
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/2515 • Up to 54 Months
|
0.20%
5/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Ischaemic Enteritis
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Large Intestinal Obstruction
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Large Intestine Polyp
|
0.04%
1/2515 • Up to 54 Months
|
0.16%
4/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Nausea
|
0.04%
1/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Pancreatic Disorder
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Pancreatic Necrosis
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.12%
3/2515 • Up to 54 Months
|
0.12%
3/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Pancreatitis Chronic
|
0.04%
1/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Ulcerative Gastritis
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Volvulus of Small Bowel
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Gastrointestinal disorders
Vomiting
|
0.08%
2/2515 • Up to 54 Months
|
0.12%
3/2507 • Up to 54 Months
|
|
General disorders
Asthenia
|
0.04%
1/2515 • Up to 54 Months
|
0.20%
5/2507 • Up to 54 Months
|
|
General disorders
Chest Discomfort
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
General disorders
Chest Pain
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
General disorders
Death
|
0.12%
3/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
General disorders
Disuse Syndrome
|
0.04%
1/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
General disorders
Drug Withdrawal Syndrome
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
General disorders
Fatigue
|
0.08%
2/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
General disorders
General Physical Health Deterioration
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
General disorders
Heteroplasia
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
General disorders
Hyperthermia Malignant
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
General disorders
Impaired Healing
|
0.04%
1/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
General disorders
Multiple Organ Dysfunction Syndrome
|
0.12%
3/2515 • Up to 54 Months
|
0.20%
5/2507 • Up to 54 Months
|
|
General disorders
Non-Cardiac Chest Pain
|
0.24%
6/2515 • Up to 54 Months
|
0.28%
7/2507 • Up to 54 Months
|
|
General disorders
Pain
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
General disorders
Pyrexia
|
0.16%
4/2515 • Up to 54 Months
|
0.16%
4/2507 • Up to 54 Months
|
|
General disorders
Soft Tissue Inflammation
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
General disorders
Sudden Death
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Hepatobiliary disorders
Acute Hepatic Failure
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Hepatobiliary disorders
Biliary Colic
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Hepatobiliary disorders
Biliary Dilatation
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Hepatobiliary disorders
Cardiac Cirrhosis
|
0.04%
1/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Hepatobiliary disorders
Cholangitis
|
0.04%
1/2515 • Up to 54 Months
|
0.12%
3/2507 • Up to 54 Months
|
|
Hepatobiliary disorders
Cholangitis Acute
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.20%
5/2515 • Up to 54 Months
|
0.40%
10/2507 • Up to 54 Months
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.28%
7/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Hepatobiliary disorders
Cholecystitis Chronic
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.12%
3/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Hepatobiliary disorders
Cirrhosis Alcoholic
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Hepatobiliary disorders
Hepatic Cirrhosis
|
0.08%
2/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.04%
1/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
0.04%
1/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Hepatobiliary disorders
Hepatic Lesion
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Hepatobiliary disorders
Hepatitis Acute
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Hepatobiliary disorders
Hepatorenal Failure
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Hepatobiliary disorders
Jaundice
|
0.04%
1/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Hepatobiliary disorders
Liver Disorder
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Hepatobiliary disorders
Portal Hypertension
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Immune system disorders
Hypersensitivity
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Abdominal Abscess
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Abscess
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Infections and infestations
Abscess Limb
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Abscess Soft Tissue
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Anal Abscess
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Appendicitis
|
0.04%
1/2515 • Up to 54 Months
|
0.12%
3/2507 • Up to 54 Months
|
|
Infections and infestations
Arthritis Bacterial
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Infections and infestations
Bacterial Infection
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Infections and infestations
Bacterial Sepsis
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Infections and infestations
Bronchitis
|
0.36%
9/2515 • Up to 54 Months
|
0.48%
12/2507 • Up to 54 Months
|
|
Infections and infestations
Bronchitis Bacterial
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Bursitis Infective
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Carbuncle
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Cellulitis
|
0.28%
7/2515 • Up to 54 Months
|
0.28%
7/2507 • Up to 54 Months
|
|
Infections and infestations
Cellulitis Gangrenous
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Infections and infestations
Cholecystitis Infective
|
0.00%
0/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Infections and infestations
Chronic Tonsillitis
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.04%
1/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Clostridium Difficile Infection
|
0.08%
2/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Infections and infestations
Cystitis
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Dengue Fever
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Infections and infestations
Device Related Infection
|
0.04%
1/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Diabetic Foot Infection
|
0.04%
1/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Infections and infestations
Diabetic Gangrene
|
0.12%
3/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Diverticulitis
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Infections and infestations
Douglas' Abscess
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Infections and infestations
Encephalitis
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Endocarditis
|
0.08%
2/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Enteritis Infectious
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Infections and infestations
Enterobacter Infection
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Infections and infestations
Epididymitis
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Erysipelas
|
0.04%
1/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Infections and infestations
Escherichia Bacteraemia
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Escherichia Infection
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Escherichia Pyelonephritis
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Infections and infestations
Escherichia Sepsis
|
0.12%
3/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Infections and infestations
Escherichia Urinary Tract Infection
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Infections and infestations
Gangrene
|
0.16%
4/2515 • Up to 54 Months
|
0.28%
7/2507 • Up to 54 Months
|
|
Infections and infestations
Gastritis Viral
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Gastroenteritis
|
0.16%
4/2515 • Up to 54 Months
|
0.24%
6/2507 • Up to 54 Months
|
|
Infections and infestations
Gastroenteritis Shigella
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Haemorrhagic Pneumonia
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Infections and infestations
Hepatitis E
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Herpes Zoster
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Infections and infestations
Herpes Zoster Infection Neurological
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Infections and infestations
Infected Dermal Cyst
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Infected Skin Ulcer
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Infection
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Infective Spondylitis
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Infections and infestations
Influenza
|
0.08%
2/2515 • Up to 54 Months
|
0.28%
7/2507 • Up to 54 Months
|
|
Infections and infestations
Intervertebral Discitis
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Localised Infection
|
0.04%
1/2515 • Up to 54 Months
|
0.12%
3/2507 • Up to 54 Months
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Infections and infestations
Lung Abscess
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Infections and infestations
Lung Infection
|
0.24%
6/2515 • Up to 54 Months
|
0.32%
8/2507 • Up to 54 Months
|
|
Infections and infestations
Medical Device Site Infection
|
0.12%
3/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Meningitis
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Infections and infestations
Myiasis
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Osteomyelitis
|
0.04%
1/2515 • Up to 54 Months
|
0.16%
4/2507 • Up to 54 Months
|
|
Infections and infestations
Pancreas Infection
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Infections and infestations
Parotid Abscess
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Infections and infestations
Periodontitis
|
0.04%
1/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Infections and infestations
Peritonitis
|
0.12%
3/2515 • Up to 54 Months
|
0.20%
5/2507 • Up to 54 Months
|
|
Infections and infestations
Pharyngeal Abscess
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Infections and infestations
Pneumonia
|
2.9%
72/2515 • Up to 54 Months
|
2.7%
68/2507 • Up to 54 Months
|
|
Infections and infestations
Pneumonia Bacterial
|
0.20%
5/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Pneumonia Klebsiella
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Pneumonia Staphylococcal
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Post Procedural Infection
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Postoperative Wound Infection
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Pulmonary Tuberculosis
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Infections and infestations
Pyelonephritis Acute
|
0.12%
3/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Infections and infestations
Pyuria
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Infections and infestations
Respiratory Tract Infection
|
0.32%
8/2515 • Up to 54 Months
|
0.40%
10/2507 • Up to 54 Months
|
|
Infections and infestations
Sepsis
|
0.28%
7/2515 • Up to 54 Months
|
0.64%
16/2507 • Up to 54 Months
|
|
Infections and infestations
Septic Shock
|
0.24%
6/2515 • Up to 54 Months
|
0.16%
4/2507 • Up to 54 Months
|
|
Infections and infestations
Sinusitis
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Infections and infestations
Staphylococcal Sepsis
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Syphilis
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Tracheitis
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.04%
1/2515 • Up to 54 Months
|
0.20%
5/2507 • Up to 54 Months
|
|
Infections and infestations
Urinary Tract Infection
|
0.36%
9/2515 • Up to 54 Months
|
0.56%
14/2507 • Up to 54 Months
|
|
Infections and infestations
Urinary Tract Infection Bacterial
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Infections and infestations
Urosepsis
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Infections and infestations
Viral Myocarditis
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Infections and infestations
Wound Infection
|
0.08%
2/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.08%
2/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Alcohol Poisoning
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.04%
1/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Bone Fissure
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Burns Third Degree
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Cervical Vertebral Fracture
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Craniocerebral Injury
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Fall
|
0.12%
3/2515 • Up to 54 Months
|
0.20%
5/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.12%
3/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.16%
4/2515 • Up to 54 Months
|
0.32%
8/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Fibula Fracture
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Foreign Body
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Gun Shot Wound
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.04%
1/2515 • Up to 54 Months
|
0.24%
6/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.08%
2/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Intentional Overdose
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.04%
1/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Multiple Fractures
|
0.04%
1/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Patella Fracture
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Pneumothorax Traumatic
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Post Procedural Complication
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Postoperative Renal Failure
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Postoperative Wound Complication
|
0.00%
0/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Radiation Pneumonitis
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.04%
1/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.12%
3/2515 • Up to 54 Months
|
0.12%
3/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.12%
3/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Tendon Rupture
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.12%
3/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Thoracic Vertebral Fracture
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Ulna Fracture
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Investigations
Biopsy Pleura
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Investigations
Biopsy Prostate
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Investigations
Blood Creatinine Increased
|
0.08%
2/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Investigations
Blood Glucose Abnormal
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Investigations
Blood Glucose Fluctuation
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Investigations
Hepatic Enzyme Increased
|
0.00%
0/2515 • Up to 54 Months
|
0.12%
3/2507 • Up to 54 Months
|
|
Investigations
Liver Function Test Increased
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Investigations
Oesophagogastroduodenoscopy
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Metabolism and nutrition disorders
Acidosis
|
0.04%
1/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.08%
2/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.12%
3/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.32%
8/2515 • Up to 54 Months
|
0.28%
7/2507 • Up to 54 Months
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
0.12%
3/2515 • Up to 54 Months
|
0.36%
9/2507 • Up to 54 Months
|
|
Metabolism and nutrition disorders
Diabetic Ketosis
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Metabolism and nutrition disorders
Diabetic Metabolic Decompensation
|
0.16%
4/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Metabolism and nutrition disorders
Fluid Retention
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.12%
3/2515 • Up to 54 Months
|
0.12%
3/2507 • Up to 54 Months
|
|
Metabolism and nutrition disorders
Hyperglycaemic Hyperosmolar Nonketotic Syndrome
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.28%
7/2515 • Up to 54 Months
|
0.16%
4/2507 • Up to 54 Months
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.20%
5/2515 • Up to 54 Months
|
0.20%
5/2507 • Up to 54 Months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.04%
1/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.20%
5/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Metabolism and nutrition disorders
Insulin-Requiring Type 2 Diabetes Mellitus
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Metabolism and nutrition disorders
Lactic Acidosis
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Metabolism and nutrition disorders
Metabolic Disorder
|
0.04%
1/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Metabolism and nutrition disorders
Type 1 Diabetes Mellitus
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.12%
3/2515 • Up to 54 Months
|
0.20%
5/2507 • Up to 54 Months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.12%
3/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Musculoskeletal and connective tissue disorders
Foot Deformity
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Musculoskeletal and connective tissue disorders
Gouty Arthritis
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Degeneration
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Disorder
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.04%
1/2515 • Up to 54 Months
|
0.16%
4/2507 • Up to 54 Months
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.08%
2/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.16%
4/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.04%
1/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.04%
1/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia Rheumatica
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
|
0.00%
0/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Musculoskeletal and connective tissue disorders
Spinal Pain
|
0.08%
2/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukaemia
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of Colon
|
0.04%
1/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.12%
3/2515 • Up to 54 Months
|
0.24%
6/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer Recurrent
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Neoplasm
|
0.04%
1/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Stage Ii
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Neoplasm
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial Carcinoma
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix Carcinoma
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic Lymphocytic Leukaemia
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear Cell Renal Cell Carcinoma
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.12%
3/2515 • Up to 54 Months
|
0.28%
7/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer Metastatic
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer Recurrent
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Neoplasm
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal Adenocarcinoma
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal Cancer
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ear Neoplasm Malignant
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial Cancer Metastatic
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epiglottic Carcinoma
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder Cancer
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
0.00%
0/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer Recurrent
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrooesophageal Cancer
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Cancer
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Cancer Stage Iv
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypopharyngeal Cancer
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal Adenocarcinoma
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma
|
0.08%
2/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer Metastatic
|
0.08%
2/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Carcinoma Cell Type Unspecified Stage Ii
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm
|
0.16%
4/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.28%
7/2515 • Up to 54 Months
|
0.28%
7/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Neoplasm of Unknown Primary Site
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Bone
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Central Nervous System
|
0.04%
1/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Liver
|
0.04%
1/2515 • Up to 54 Months
|
0.16%
4/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Lung
|
0.08%
2/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Neoplasm
|
0.00%
0/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Renal Cell Carcinoma
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Monoclonal Gammopathy
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Malignant
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm of Orbit
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's Lymphoma
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal Adenocarcinoma
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal Squamous Cell Carcinoma
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
0.04%
1/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma Metastatic
|
0.08%
2/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma Cell Myeloma
|
0.08%
2/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.16%
4/2515 • Up to 54 Months
|
0.16%
4/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer Metastatic
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer Stage Iv
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic Adenoma
|
0.04%
1/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Adenocarcinoma
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer Stage Iii
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Neoplasm
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cancer
|
0.08%
2/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cancer Metastatic
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Neoplasm
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small Cell Carcinoma
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small Intestine Carcinoma
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testis Cancer
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Throat Cancer
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Cancer
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue Neoplasm
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue Neoplasm Malignant Stage Unspecified
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional Cell Carcinoma
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Nervous system disorders
Amyotrophic Lateral Sclerosis
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Nervous system disorders
Brain Injury
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Nervous system disorders
Brain Oedema
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Nervous system disorders
Cervicobrachial Syndrome
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Nervous system disorders
Dementia
|
0.00%
0/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Nervous system disorders
Diabetic Neuropathy
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Nervous system disorders
Dizziness Postural
|
0.04%
1/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Nervous system disorders
Encephalopathy
|
0.04%
1/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Nervous system disorders
Epilepsy
|
0.04%
1/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Nervous system disorders
Headache
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Nervous system disorders
Hemianopia
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Nervous system disorders
Hypoglycaemic Coma
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Nervous system disorders
Hypoxic-Ischaemic Encephalopathy
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Nervous system disorders
Intercostal Neuralgia
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Nervous system disorders
Ischaemic Neuropathy
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Nervous system disorders
Loss of Consciousness
|
0.04%
1/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Nervous system disorders
Lumbosacral Radiculopathy
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Nervous system disorders
Metabolic Encephalopathy
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Nervous system disorders
Neuroglycopenia
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Nervous system disorders
Sciatica
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Nervous system disorders
Seizure
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Nervous system disorders
Syncope
|
0.12%
3/2515 • Up to 54 Months
|
0.24%
6/2507 • Up to 54 Months
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Nervous system disorders
Vertebrobasilar Insufficiency
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Product Issues
Device Dislocation
|
0.08%
2/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Psychiatric disorders
Alcohol Abuse
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Psychiatric disorders
Alcohol Withdrawal Syndrome
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Psychiatric disorders
Antisocial Personality Disorder
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Psychiatric disorders
Anxiety Disorder
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Psychiatric disorders
Delirium
|
0.04%
1/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Psychiatric disorders
Depression
|
0.04%
1/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Psychiatric disorders
Illness Anxiety Disorder
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Psychiatric disorders
Major Depression
|
0.08%
2/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Psychiatric disorders
Psychotic Disorder Due to A General Medical Condition
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Psychiatric disorders
Self-Injurious Ideation
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Psychiatric disorders
Suicidal Ideation
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Psychiatric disorders
Suicide Attempt
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.1%
28/2515 • Up to 54 Months
|
0.68%
17/2507 • Up to 54 Months
|
|
Renal and urinary disorders
Calculus Urinary
|
0.04%
1/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.28%
7/2515 • Up to 54 Months
|
0.56%
14/2507 • Up to 54 Months
|
|
Renal and urinary disorders
Diabetic Nephropathy
|
0.04%
1/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Renal and urinary disorders
End Stage Renal Disease
|
0.04%
1/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Renal and urinary disorders
Glomerulonephritis
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Renal and urinary disorders
Iga Nephropathy
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/2515 • Up to 54 Months
|
0.12%
3/2507 • Up to 54 Months
|
|
Renal and urinary disorders
Nephropathy Toxic
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Renal and urinary disorders
Nephrotic Syndrome
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Renal and urinary disorders
Prerenal Failure
|
0.00%
0/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Renal and urinary disorders
Renal Artery Stenosis
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Renal and urinary disorders
Renal Colic
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Renal and urinary disorders
Renal Failure
|
0.48%
12/2515 • Up to 54 Months
|
0.48%
12/2507 • Up to 54 Months
|
|
Renal and urinary disorders
Renal Impairment
|
0.36%
9/2515 • Up to 54 Months
|
0.16%
4/2507 • Up to 54 Months
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Renal and urinary disorders
Urethral Stenosis
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Renal and urinary disorders
Urinary Retention
|
0.04%
1/2515 • Up to 54 Months
|
0.12%
3/2507 • Up to 54 Months
|
|
Renal and urinary disorders
Urinary Tract Disorder
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.04%
1/2515 • Up to 54 Months
|
0.16%
4/2507 • Up to 54 Months
|
|
Reproductive system and breast disorders
Cystocele
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.04%
1/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Reproductive system and breast disorders
Ovarian Cyst Torsion
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Reproductive system and breast disorders
Uterine Polyp
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.12%
3/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.08%
2/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.08%
2/2515 • Up to 54 Months
|
0.20%
5/2507 • Up to 54 Months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.04%
1/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis Chronic
|
0.04%
1/2515 • Up to 54 Months
|
0.16%
4/2507 • Up to 54 Months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.64%
16/2515 • Up to 54 Months
|
0.60%
15/2507 • Up to 54 Months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.08%
2/2515 • Up to 54 Months
|
0.16%
4/2507 • Up to 54 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Paroxysmal Nocturnal
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.08%
2/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infiltration
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Respiratory, thoracic and mediastinal disorders
Necrotising Bronchiolitis
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.08%
2/2515 • Up to 54 Months
|
0.12%
3/2507 • Up to 54 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.04%
1/2515 • Up to 54 Months
|
0.16%
4/2507 • Up to 54 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.04%
1/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Fibrosis
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Mass
|
0.04%
1/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.12%
3/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.20%
5/2515 • Up to 54 Months
|
0.36%
9/2507 • Up to 54 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Inflammation
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnoea Syndrome
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Respiratory, thoracic and mediastinal disorders
Vocal Cord Thickening
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.04%
1/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Skin and subcutaneous tissue disorders
Diabetic Foot
|
0.16%
4/2515 • Up to 54 Months
|
0.24%
6/2507 • Up to 54 Months
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic Eczema
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Skin and subcutaneous tissue disorders
Hypersensitivity Vasculitis
|
0.08%
2/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Skin and subcutaneous tissue disorders
Necrobiosis Lipoidica Diabeticorum
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Skin and subcutaneous tissue disorders
Rash Generalised
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Skin and subcutaneous tissue disorders
Rash Macular
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.08%
2/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Skin and subcutaneous tissue disorders
Toxic Epidermal Necrolysis
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Surgical and medical procedures
Anal Sphincterotomy
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Surgical and medical procedures
Bile Duct Stent Removal
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Surgical and medical procedures
Breast Tumour Excision
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Surgical and medical procedures
Cataract Operation
|
0.08%
2/2515 • Up to 54 Months
|
0.12%
3/2507 • Up to 54 Months
|
|
Surgical and medical procedures
Chemotherapy
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Surgical and medical procedures
Cyst Removal
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Surgical and medical procedures
Debridement
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Surgical and medical procedures
Diabetes Mellitus Management
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Surgical and medical procedures
Drug Therapy
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Surgical and medical procedures
Hernia Repair
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Surgical and medical procedures
Ileostomy
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Surgical and medical procedures
Inguinal Hernia Repair
|
0.00%
0/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Surgical and medical procedures
Insertion of Ambulatory Peritoneal Catheter
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Surgical and medical procedures
Leg Amputation
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Surgical and medical procedures
Peripheral Artery Bypass
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Surgical and medical procedures
Prosthetic Vessel Implantation
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Surgical and medical procedures
Removal of Ambulatory Peritoneal Catheter
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Surgical and medical procedures
Spinal Fusion Surgery
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Surgical and medical procedures
Spinal Laminectomy
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Surgical and medical procedures
Transurethral Prostatectomy
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Vascular disorders
Aortic Aneurysm
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Vascular disorders
Aortic Dissection
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Vascular disorders
Arterial Haemorrhage
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Vascular disorders
Arteriosclerosis
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Vascular disorders
Circulatory Collapse
|
0.04%
1/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Vascular disorders
Cryoglobulinaemia
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Vascular disorders
Diabetic Vascular Disorder
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Vascular disorders
Extremity Necrosis
|
0.00%
0/2515 • Up to 54 Months
|
0.12%
3/2507 • Up to 54 Months
|
|
Vascular disorders
Hypertension
|
0.08%
2/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Vascular disorders
Hypotension
|
0.08%
2/2515 • Up to 54 Months
|
0.16%
4/2507 • Up to 54 Months
|
|
Vascular disorders
Hypovolaemic Shock
|
0.00%
0/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Vascular disorders
Orthostatic Hypotension
|
0.08%
2/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Vascular disorders
Peripheral Ischaemia
|
0.00%
0/2515 • Up to 54 Months
|
0.08%
2/2507 • Up to 54 Months
|
|
Vascular disorders
Peripheral Vascular Disorder
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Vascular disorders
Phlebitis Superficial
|
0.04%
1/2515 • Up to 54 Months
|
0.00%
0/2507 • Up to 54 Months
|
|
Vascular disorders
Subclavian Artery Stenosis
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/2515 • Up to 54 Months
|
0.04%
1/2507 • Up to 54 Months
|
Other adverse events
| Measure |
Placebo
n=2515 participants at risk
Participants received matching placebo orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
|
Rivaroxaban
n=2507 participants at risk
Participants received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
2.4%
60/2515 • Up to 54 Months
|
2.1%
53/2507 • Up to 54 Months
|
Additional Information
SENIOR DIRECTOR, CLINICAL LEADER CV
Janssen Research & Development, LLC
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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 in writing, such publication will be withheld for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER