Trial Outcomes & Findings for A Study of Vericiguat in Participants With Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-001) (NCT NCT02861534)
NCT ID: NCT02861534
Last Updated: 2021-11-15
Results Overview
Time to First Occurrence of Composite Endpoint of CV Death or HF Hospitalization was analyzed using a one-sided stratified log-rank test. Randomized participants without any HF hospitalization or CV death event at the time of analysis were censored at their last available information, the date of their non-CV death, or the primary analysis database cutoff date of 18-June-2019, whichever occurred first. A clinical events committee (CEC) reviewed and adjudicated the endpoint events. A time-to-event methodology was used to evaluate the results; the incidence rate of participants with an event (number of participants with an event per 100 participant-years at risk) is provided.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
5050 participants
Primary outcome timeframe
Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)
Results posted on
2021-11-15
Participant Flow
Participant milestones
| Measure |
Vericiguat
Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily with food, on a background of heart failure (HF) standard of care. The vericiguat dose was uptitrated to 5 mg and to 10 mg.
|
Placebo
Participants received a starting matching placebo dose of 2.5 mg taken orally once daily with food, on a background of HF standard of care. The matching placebo dose was uptitrated to 5 mg and to 10 mg.
|
|---|---|---|
|
Overall Study
STARTED
|
2526
|
2524
|
|
Overall Study
Treated
|
2519
|
2515
|
|
Overall Study
COMPLETED
|
1952
|
1937
|
|
Overall Study
NOT COMPLETED
|
574
|
587
|
Reasons for withdrawal
| Measure |
Vericiguat
Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily with food, on a background of heart failure (HF) standard of care. The vericiguat dose was uptitrated to 5 mg and to 10 mg.
|
Placebo
Participants received a starting matching placebo dose of 2.5 mg taken orally once daily with food, on a background of HF standard of care. The matching placebo dose was uptitrated to 5 mg and to 10 mg.
|
|---|---|---|
|
Overall Study
Death
|
541
|
552
|
|
Overall Study
Lost to Follow-up
|
14
|
14
|
|
Overall Study
Site Terminated by Sponsor
|
4
|
3
|
|
Overall Study
Withdrawal by Subject
|
15
|
18
|
Baseline Characteristics
A Study of Vericiguat in Participants With Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-001)
Baseline characteristics by cohort
| Measure |
Vericiguat
n=2526 Participants
Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily with food, on a background of heart failure (HF) standard of care. The vericiguat dose was uptitrated to 5 mg and to 10 mg.
|
Placebo
n=2524 Participants
Participants received a starting matching placebo dose of 2.5 mg taken orally once daily with food, on a background of HF standard of care. The matching placebo dose was uptitrated to 5 mg and to 10 mg.
|
Total
n=5050 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.5 Years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
67.2 Years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
67.3 Years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
605 Participants
n=5 Participants
|
603 Participants
n=7 Participants
|
1208 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1921 Participants
n=5 Participants
|
1921 Participants
n=7 Participants
|
3842 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
24 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
571 Participants
n=5 Participants
|
561 Participants
n=7 Participants
|
1132 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
123 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
249 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1621 Participants
n=5 Participants
|
1618 Participants
n=7 Participants
|
3239 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
183 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
363 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)Population: All randomized participants
Time to First Occurrence of Composite Endpoint of CV Death or HF Hospitalization was analyzed using a one-sided stratified log-rank test. Randomized participants without any HF hospitalization or CV death event at the time of analysis were censored at their last available information, the date of their non-CV death, or the primary analysis database cutoff date of 18-June-2019, whichever occurred first. A clinical events committee (CEC) reviewed and adjudicated the endpoint events. A time-to-event methodology was used to evaluate the results; the incidence rate of participants with an event (number of participants with an event per 100 participant-years at risk) is provided.
Outcome measures
| Measure |
Vericiguat
n=2526 Participants
Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily with food, on a background of HF standard of care. The vericiguat dose was uptitrated to 5 mg and to 10 mg.
|
Placebo
n=2524 Participants
Participants received a starting matching placebo dose of 2.5 mg taken orally once daily with food, on a background of HF standard of care. The matching placebo dose was uptitrated to 5 mg and to 10 mg.
|
|---|---|---|
|
Time to First Occurrence of Composite Endpoint of Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization
|
33.6 Parts w/ event per 100 part-yrs at risk
Interval 41.5 to 46.4
|
37.8 Parts w/ event per 100 part-yrs at risk
Interval 44.4 to 49.4
|
SECONDARY outcome
Timeframe: Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)Population: All randomized participants
Time to First Occurrence of CV Death was analyzed using a one-sided stratified log-rank test. Randomized participants without a CV death at the time of analysis were censored at their last available information, the date of their non-CV death, or the primary analysis database cutoff date of 18-June-2019, whichever occurred first. A CEC reviewed and adjudicated the endpoint events. A time-to-event methodology was used to evaluate the results; the incidence rate of participants with an event (number of participants with an event per 100 participant-years at risk) is provided.
Outcome measures
| Measure |
Vericiguat
n=2526 Participants
Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily with food, on a background of HF standard of care. The vericiguat dose was uptitrated to 5 mg and to 10 mg.
|
Placebo
n=2524 Participants
Participants received a starting matching placebo dose of 2.5 mg taken orally once daily with food, on a background of HF standard of care. The matching placebo dose was uptitrated to 5 mg and to 10 mg.
|
|---|---|---|
|
Time to the First Occurrence of CV Death
|
12.9 Parts w/ event per 100 part-yrs at risk
|
13.9 Parts w/ event per 100 part-yrs at risk
|
SECONDARY outcome
Timeframe: Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)Population: All randomized participants
Time to the First Occurrence of HF Hospitalization was analyzed using a one-sided stratified log-rank test. Randomized participants without any HF hospitalization at the time of analysis were censored at their last available information, the date of their death, or the primary analysis database cutoff date of 18-June-2019, whichever occurred first. A CEC reviewed and adjudicated the endpoint events. A time-to-event methodology was used to evaluate the results; the incidence rate of participants with an event (number of participants with an event per 100 participant-years at risk) is provided.
Outcome measures
| Measure |
Vericiguat
n=2526 Participants
Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily with food, on a background of HF standard of care. The vericiguat dose was uptitrated to 5 mg and to 10 mg.
|
Placebo
n=2524 Participants
Participants received a starting matching placebo dose of 2.5 mg taken orally once daily with food, on a background of HF standard of care. The matching placebo dose was uptitrated to 5 mg and to 10 mg.
|
|---|---|---|
|
Time to the First Occurrence of HF Hospitalization
|
25.9 Parts w/ event per 100 part-yrs at risk
|
29.1 Parts w/ event per 100 part-yrs at risk
|
SECONDARY outcome
Timeframe: Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)Population: All randomized participants
Time to Total HF Hospitalizations (including first and recurring) was analyzed using an Andersen-Gill model. Randomized participants without any HF hospitalization at the time of analysis were censored at their last available information, the date of their death, or the primary analysis database cutoff date of 18-June-2019, whichever occurred first. A CEC reviewed and adjudicated the endpoint events. A time-to-event methodology was used to evaluate the results; the incidence rate of participants with an event (number of participants with an event per 100 participant-years of follow-up) is provided.
Outcome measures
| Measure |
Vericiguat
n=2526 Participants
Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily with food, on a background of HF standard of care. The vericiguat dose was uptitrated to 5 mg and to 10 mg.
|
Placebo
n=2524 Participants
Participants received a starting matching placebo dose of 2.5 mg taken orally once daily with food, on a background of HF standard of care. The matching placebo dose was uptitrated to 5 mg and to 10 mg.
|
|---|---|---|
|
Time to Total HF Hospitalizations (Including First and Recurrent Events)
|
38.3 Parts w/ event per 100 part-yrs
|
42.4 Parts w/ event per 100 part-yrs
|
SECONDARY outcome
Timeframe: Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)Population: All randomized participants
Time to First Occurrence of Composite Endpoint of All-Cause Mortality or HF Hospitalization was analyzed using a one-sided stratified log-rank test. Randomized participants without any all-cause mortality event or HF hospitalization at the time of analysis were censored at their last available information or the primary analysis database cutoff date of 18-June-2019, whichever occurred first. A CEC reviewed and adjudicated the endpoint events. A time-to-event methodology was used to evaluate the results; the incidence rate of participants with an event (number of participants with an event per 100 participant-years at risk) is provided.
Outcome measures
| Measure |
Vericiguat
n=2526 Participants
Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily with food, on a background of HF standard of care. The vericiguat dose was uptitrated to 5 mg and to 10 mg.
|
Placebo
n=2524 Participants
Participants received a starting matching placebo dose of 2.5 mg taken orally once daily with food, on a background of HF standard of care. The matching placebo dose was uptitrated to 5 mg and to 10 mg.
|
|---|---|---|
|
Time to First Occurrence of Composite Endpoint of All-Cause Mortality or HF Hospitalization
|
35.9 Parts w/ event per 100 part-yrs at risk
|
40.1 Parts w/ event per 100 part-yrs at risk
|
SECONDARY outcome
Timeframe: Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)Population: All randomized participants
Time to All-Cause Mortality was analyzed using a one-sided stratified log-rank test. Randomized participants without any all-cause mortality event at the time of analysis were censored at their last available information or the primary analysis database cutoff date of 18-June-2019, whichever occurred first. A CEC reviewed and adjudicated the endpoint events. A time-to-event methodology was used to evaluate the results: the incidence rate of participants with an event (number of participants with an event per 100 participant-years at risk) is provided.
Outcome measures
| Measure |
Vericiguat
n=2526 Participants
Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily with food, on a background of HF standard of care. The vericiguat dose was uptitrated to 5 mg and to 10 mg.
|
Placebo
n=2524 Participants
Participants received a starting matching placebo dose of 2.5 mg taken orally once daily with food, on a background of HF standard of care. The matching placebo dose was uptitrated to 5 mg and to 10 mg.
|
|---|---|---|
|
Time to All-Cause Mortality
|
16.0 Parts w/ event per 100 part-yrs at risk
|
16.9 Parts w/ event per 100 part-yrs at risk
|
SECONDARY outcome
Timeframe: Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)Population: All randomized participants who received at least 1 dose of study treatment
An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Outcome measures
| Measure |
Vericiguat
n=2519 Participants
Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily with food, on a background of HF standard of care. The vericiguat dose was uptitrated to 5 mg and to 10 mg.
|
Placebo
n=2515 Participants
Participants received a starting matching placebo dose of 2.5 mg taken orally once daily with food, on a background of HF standard of care. The matching placebo dose was uptitrated to 5 mg and to 10 mg.
|
|---|---|---|
|
Number of Participants Who Experienced One or More Adverse Events
|
2027 Participants
|
2036 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)Population: All randomized participants who received at least 1 dose of study treatment
An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Outcome measures
| Measure |
Vericiguat
n=2519 Participants
Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily with food, on a background of HF standard of care. The vericiguat dose was uptitrated to 5 mg and to 10 mg.
|
Placebo
n=2515 Participants
Participants received a starting matching placebo dose of 2.5 mg taken orally once daily with food, on a background of HF standard of care. The matching placebo dose was uptitrated to 5 mg and to 10 mg.
|
|---|---|---|
|
Number of Participants Who Discontinued Treatment Due to an Adverse Event
|
167 Participants
|
158 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)Population: All randomized participants who received at least 1 dose of study treatment
Study participants were monitored for symptomatic hypotension, an event of clinical interest, and results were reported.
Outcome measures
| Measure |
Vericiguat
n=2519 Participants
Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily with food, on a background of HF standard of care. The vericiguat dose was uptitrated to 5 mg and to 10 mg.
|
Placebo
n=2515 Participants
Participants received a starting matching placebo dose of 2.5 mg taken orally once daily with food, on a background of HF standard of care. The matching placebo dose was uptitrated to 5 mg and to 10 mg.
|
|---|---|---|
|
Percentage of Participants Who Experienced Symptomatic Hypotension
|
9.1 Percentage of participants
|
7.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to approximately 33 months (through primary analysis database cutoff date of 18-June-2019)Population: All randomized participants who received at least 1 dose of study treatment
Study participants were monitored for syncope, an event of clinical interest, and results were reported.
Outcome measures
| Measure |
Vericiguat
n=2519 Participants
Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily with food, on a background of HF standard of care. The vericiguat dose was uptitrated to 5 mg and to 10 mg.
|
Placebo
n=2515 Participants
Participants received a starting matching placebo dose of 2.5 mg taken orally once daily with food, on a background of HF standard of care. The matching placebo dose was uptitrated to 5 mg and to 10 mg.
|
|---|---|---|
|
Percentage of Participants Who Experienced Syncope
|
4.0 Percentage of participants
|
3.5 Percentage of participants
|
Adverse Events
Vericiguat
Serious events: 852 serious events
Other events: 958 other events
Deaths: 553 deaths
Placebo
Serious events: 897 serious events
Other events: 925 other events
Deaths: 561 deaths
Serious adverse events
| Measure |
Vericiguat
n=2519 participants at risk
Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily with food, on a background of HF standard of care. The vericiguat dose was uptitrated to 5 mg and to 10 mg.
|
Placebo
n=2515 participants at risk
Participants received a starting matching placebo dose of 2.5 mg taken orally once daily with food, on a background of HF standard of care. The matching placebo dose was uptitrated to 5 mg and to 10 mg.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.16%
4/2519 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.24%
6/2519 • Number of events 6 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.12%
3/2515 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Acute coronary syndrome
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.16%
4/2515 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Acute myocardial infarction
|
0.20%
5/2519 • Number of events 6 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.20%
5/2515 • Number of events 5 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Angina pectoris
|
0.36%
9/2519 • Number of events 10 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.32%
8/2515 • Number of events 9 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Angina unstable
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.28%
7/2515 • Number of events 13 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Aortic valve calcification
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Eye disorders
Vitreous haemorrhage
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.16%
4/2519 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Hepatobiliary disorders
Hepatic failure
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.16%
4/2519 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Hepatobiliary disorders
Liver disorder
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Implant site cellulitis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
41/2519 • Number of events 50 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.95%
24/2515 • Number of events 25 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Blood and lymphatic system disorders
Bicytopenia
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Blood and lymphatic system disorders
Hypocoagulable state
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.12%
3/2519 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.12%
3/2519 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Aortic valve stenosis
|
0.12%
3/2519 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.12%
3/2515 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Arrhythmia
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Atrial fibrillation
|
0.56%
14/2519 • Number of events 15 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
1.2%
29/2515 • Number of events 31 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Atrial flutter
|
0.24%
6/2519 • Number of events 7 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.28%
7/2515 • Number of events 7 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Atrioventricular block
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Bradycardia
|
0.12%
3/2519 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.12%
3/2515 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Cardiac arrest
|
0.12%
3/2519 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.12%
3/2515 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Cardiac asthma
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Cardiac failure
|
3.3%
82/2519 • Number of events 88 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
4.6%
116/2515 • Number of events 128 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Cardiac failure acute
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.16%
4/2515 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Cardiac failure chronic
|
0.20%
5/2519 • Number of events 5 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.40%
10/2515 • Number of events 10 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Cardiac failure congestive
|
0.52%
13/2519 • Number of events 13 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.99%
25/2515 • Number of events 25 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Cardiac perforation
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.16%
4/2519 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Cardiogenic shock
|
0.32%
8/2519 • Number of events 8 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.16%
4/2515 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Cardiorenal syndrome
|
0.12%
3/2519 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Cardiovascular disorder
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.12%
3/2519 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.12%
3/2515 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Coronary artery disease
|
0.28%
7/2519 • Number of events 8 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.12%
3/2515 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Coronary artery stenosis
|
0.12%
3/2519 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Extrasystoles
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Heart valve incompetence
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Intracardiac thrombus
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Mitral valve incompetence
|
0.28%
7/2519 • Number of events 7 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.20%
5/2515 • Number of events 5 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Myocardial infarction
|
0.24%
6/2519 • Number of events 6 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.12%
3/2515 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Myocardial ischaemia
|
0.12%
3/2519 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Palpitations
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Pericarditis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Sinus bradycardia
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Sinus node dysfunction
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Ventricular dysfunction
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Ventricular fibrillation
|
0.36%
9/2519 • Number of events 10 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.28%
7/2515 • Number of events 9 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Ventricular tachycardia
|
0.56%
14/2519 • Number of events 18 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
1.1%
27/2515 • Number of events 29 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Congenital, familial and genetic disorders
Corneal dystrophy
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Congenital, familial and genetic disorders
Gastrointestinal arteriovenous malformation
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Congenital, familial and genetic disorders
Pyloric stenosis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Ear and labyrinth disorders
Vertigo
|
0.12%
3/2519 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.28%
7/2515 • Number of events 7 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.12%
3/2515 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Endocrine disorders
Basedow's disease
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Endocrine disorders
Carcinoid syndrome
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Endocrine disorders
Glucocorticoid deficiency
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Endocrine disorders
Hyperthyroidism
|
0.16%
4/2519 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Endocrine disorders
Hypoparathyroidism secondary
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Eye disorders
Blindness
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Eye disorders
Cataract
|
0.36%
9/2519 • Number of events 10 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.24%
6/2515 • Number of events 8 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Eye disorders
Diabetic retinopathy
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Eye disorders
Diplopia
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Eye disorders
Eye haemorrhage
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Eye disorders
Glaucoma
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Eye disorders
Macular cyst
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Eye disorders
Retinal artery thrombosis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Abdominal pain
|
0.16%
4/2519 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.16%
4/2515 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.16%
4/2519 • Number of events 5 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.12%
3/2515 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Anorectal ulcer
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Ascites
|
0.32%
8/2519 • Number of events 10 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.16%
4/2515 • Number of events 5 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Colitis
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Constipation
|
0.12%
3/2519 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Dental cyst
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Diarrhoea
|
0.40%
10/2519 • Number of events 10 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.28%
7/2515 • Number of events 7 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Diverticulum
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.12%
3/2515 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Gastric perforation
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Gastritis
|
0.16%
4/2519 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.28%
7/2515 • Number of events 7 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.48%
12/2519 • Number of events 14 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.28%
7/2515 • Number of events 7 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.16%
4/2515 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Haematemesis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.12%
3/2519 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Ileus
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.12%
3/2515 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.44%
11/2519 • Number of events 11 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.36%
9/2515 • Number of events 9 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Inguinal hernia strangulated
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Ischaemic enteritis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Large intestinal ulcer haemorrhage
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Large intestinal ulcer perforation
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.04%
1/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.16%
4/2515 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Melaena
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Nausea
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Oesophageal achalasia
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Pancreatitis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Pancreatolithiasis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.12%
3/2519 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.24%
6/2515 • Number of events 6 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Vomiting
|
0.16%
4/2519 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
General disorders
Asthenia
|
0.24%
6/2519 • Number of events 6 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.24%
6/2515 • Number of events 7 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
General disorders
Cardiac complication associated with device
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
General disorders
Chest discomfort
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
General disorders
Chest pain
|
0.40%
10/2519 • Number of events 10 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.32%
8/2515 • Number of events 14 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
General disorders
Device related thrombosis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
General disorders
Discomfort
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
General disorders
General physical health deterioration
|
0.24%
6/2519 • Number of events 6 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
General disorders
Generalised oedema
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
General disorders
Hernia
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
General disorders
Impaired healing
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
General disorders
Implant site erythema
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
General disorders
Implant site haematoma
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
General disorders
Implant site haemorrhage
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
General disorders
Influenza like illness
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
General disorders
Medical device pain
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
General disorders
Medical device site haematoma
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
General disorders
Medical device site swelling
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
General disorders
Medical device site thrombosis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.16%
4/2515 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
General disorders
Non-cardiac chest pain
|
0.16%
4/2519 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.28%
7/2515 • Number of events 7 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
General disorders
Oedema
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
General disorders
Oedema peripheral
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.12%
3/2515 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
General disorders
Physical deconditioning
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
General disorders
Pyrexia
|
0.12%
3/2519 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
General disorders
Sensation of foreign body
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
General disorders
Strangulated hernia
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
General disorders
Sudden cardiac death
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
General disorders
UGT1A1 gene polymorphism
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
General disorders
Vascular stent occlusion
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
General disorders
Vascular stent stenosis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
General disorders
Vascular stent thrombosis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.12%
3/2515 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Hepatobiliary disorders
Bile duct stone
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Hepatobiliary disorders
Biloma
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Hepatobiliary disorders
Cholangitis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Hepatobiliary disorders
Cholecystitis
|
0.16%
4/2519 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.16%
4/2515 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.16%
4/2519 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.24%
6/2515 • Number of events 6 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.16%
4/2519 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Hepatobiliary disorders
Cholestasis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Hepatobiliary disorders
Chronic hepatic failure
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Hepatobiliary disorders
Hepatic congestion
|
0.16%
4/2519 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Hepatobiliary disorders
Liver injury
|
0.20%
5/2519 • Number of events 5 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Hepatobiliary disorders
Portosplenomesenteric venous thrombosis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Immune system disorders
Amyloidosis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Abscess limb
|
0.12%
3/2519 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Acinetobacter bacteraemia
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Amoebic dysentery
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Anal abscess
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Appendicitis
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Arteriovenous fistula site infection
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Bacterial sepsis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Bronchitis
|
0.40%
10/2519 • Number of events 10 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.28%
7/2515 • Number of events 7 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Bronchitis viral
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Cellulitis
|
0.99%
25/2519 • Number of events 27 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.76%
19/2515 • Number of events 20 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Cellulitis gangrenous
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Chest wall abscess
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Chronic sinusitis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Clostridium difficile colitis
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Complicated appendicitis
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Cystitis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Cystitis bacterial
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Device related infection
|
0.16%
4/2519 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Diabetic foot infection
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Diarrhoea infectious
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Disseminated tuberculosis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Diverticulitis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Endocarditis
|
0.16%
4/2519 • Number of events 7 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Enteritis infectious
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Enterocolitis viral
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Epididymitis
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Erysipelas
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.24%
6/2515 • Number of events 6 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Extradural abscess
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Eye infection bacterial
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Febrile infection
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Fungaemia
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Gangrene
|
0.16%
4/2519 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.16%
4/2515 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Gas gangrene
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Gastroenteritis
|
0.64%
16/2519 • Number of events 16 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.40%
10/2515 • Number of events 10 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Groin abscess
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
H1N1 influenza
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Haematoma infection
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Implant site infection
|
0.12%
3/2519 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.12%
3/2515 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Infected bite
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Infected skin ulcer
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Infection
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.12%
3/2515 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Infectious pleural effusion
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.12%
3/2515 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Influenza
|
0.44%
11/2519 • Number of events 11 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.32%
8/2515 • Number of events 8 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Intervertebral discitis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Intestinal sepsis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Liver abscess
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Localised infection
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Lower respiratory tract infection
|
0.28%
7/2519 • Number of events 8 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.16%
4/2515 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Lung infection
|
0.40%
10/2519 • Number of events 12 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.12%
3/2515 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Measles
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Medical device site abscess
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Myocarditis infectious
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Necrotising fasciitis
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Nosocomial infection
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Osteomyelitis
|
0.24%
6/2519 • Number of events 6 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.24%
6/2515 • Number of events 7 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Osteomyelitis acute
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Osteomyelitis chronic
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Otitis externa
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Parotid abscess
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Periodontitis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Perirectal abscess
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Peritonitis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Peritonitis bacterial
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Pertussis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Pneumonia
|
4.1%
104/2519 • Number of events 113 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
4.6%
116/2515 • Number of events 127 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Pneumonia bacterial
|
0.12%
3/2519 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.16%
4/2515 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Pneumonia chlamydial
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Pneumonia streptococcal
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Pneumonia viral
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Postoperative wound infection
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Psoas abscess
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Pulmonary sepsis
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.12%
3/2515 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Pyelonephritis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Pyelonephritis chronic
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Renal abscess
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Respiratory tract infection
|
0.20%
5/2519 • Number of events 5 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.16%
4/2515 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Salmonella bacteraemia
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Sepsis
|
0.64%
16/2519 • Number of events 16 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.99%
25/2515 • Number of events 25 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Septic shock
|
0.44%
11/2519 • Number of events 11 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.56%
14/2515 • Number of events 14 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Serratia bacteraemia
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Sinusitis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Skin bacterial infection
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Skin infection
|
0.08%
2/2519 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Staphylococcal infection
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Staphylococcal sepsis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Staphylococcal skin infection
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Subcutaneous abscess
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Systemic candida
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Thrombophlebitis septic
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Tracheobronchitis
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Tuberculous pleurisy
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Typhoid fever
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Upper respiratory tract infection
|
0.44%
11/2519 • Number of events 11 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.40%
10/2515 • Number of events 10 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Ureter abscess
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Urinary tract infection
|
0.79%
20/2519 • Number of events 23 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.64%
16/2515 • Number of events 18 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Urosepsis
|
0.28%
7/2519 • Number of events 8 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Vestibular neuronitis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Viral diarrhoea
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Viral infection
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.12%
3/2519 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
West Nile viral infection
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Wound infection
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.16%
4/2515 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Wound sepsis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Arterial bypass occlusion
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Asbestosis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Bone fissure
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Cardiac valve replacement complication
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Concussion
|
0.12%
3/2519 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Contusion
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Coronary vascular graft stenosis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Costal cartilage fracture
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Fall
|
0.24%
6/2519 • Number of events 6 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.20%
5/2515 • Number of events 5 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.08%
2/2519 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.32%
8/2515 • Number of events 8 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.12%
3/2519 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.48%
12/2515 • Number of events 12 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Head injury
|
0.16%
4/2519 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.24%
6/2519 • Number of events 6 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.12%
3/2515 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.12%
3/2515 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.20%
5/2515 • Number of events 5 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Overdose
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Penis injury
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Post procedural hypothyroidism
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Postoperative hypotension
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Sedation complication
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Seroma
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.12%
3/2519 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Snake bite
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.24%
6/2519 • Number of events 6 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Suture related complication
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.24%
6/2515 • Number of events 6 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Traumatic liver injury
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Traumatic ulcer
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.12%
3/2515 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Vasoplegia syndrome
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Investigations
Angiocardiogram
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Investigations
Anticoagulation drug level above therapeutic
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Investigations
Blood creatinine increased
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Investigations
Blood potassium increased
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Investigations
Blood sodium decreased
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Investigations
Blood urea increased
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Investigations
Bone density abnormal
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Investigations
Cardiac index abnormal
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Investigations
Cardiac stress test abnormal
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Investigations
Catheterisation cardiac
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Investigations
Cortisol decreased
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.12%
3/2515 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Investigations
Haemoglobin decreased
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Investigations
Heart rate irregular
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Investigations
Hepatic enzyme abnormal
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Investigations
Hepatic enzyme increased
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Investigations
Influenza A virus test positive
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Investigations
International normalised ratio increased
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Investigations
Liver function test abnormal
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Investigations
Liver function test increased
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Investigations
Occult blood positive
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Investigations
Transaminases increased
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Investigations
Troponin increased
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Investigations
Weight decreased
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Investigations
Weight increased
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Metabolism and nutrition disorders
Cachexia
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Metabolism and nutrition disorders
Dehydration
|
0.28%
7/2519 • Number of events 7 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.48%
12/2515 • Number of events 13 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.20%
5/2519 • Number of events 6 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.40%
10/2515 • Number of events 11 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Metabolism and nutrition disorders
Diabetes with hyperosmolarity
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.16%
4/2519 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Metabolism and nutrition disorders
Gout
|
0.40%
10/2519 • Number of events 12 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.48%
12/2515 • Number of events 14 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.24%
6/2519 • Number of events 6 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.16%
4/2515 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.12%
3/2519 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.52%
13/2519 • Number of events 13 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.56%
14/2515 • Number of events 14 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Metabolism and nutrition disorders
Hyperosmolar state
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.48%
12/2519 • Number of events 13 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.36%
9/2515 • Number of events 9 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.28%
7/2519 • Number of events 8 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.28%
7/2515 • Number of events 7 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.20%
5/2519 • Number of events 5 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.20%
5/2515 • Number of events 5 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Metabolism and nutrition disorders
Marasmus
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.16%
4/2515 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Metabolism and nutrition disorders
Mineral metabolism disorder
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.20%
5/2519 • Number of events 5 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.32%
8/2515 • Number of events 8 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Musculoskeletal and connective tissue disorders
Chondritis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Musculoskeletal and connective tissue disorders
Enthesopathy
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.28%
7/2519 • Number of events 9 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.24%
6/2515 • Number of events 7 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Musculoskeletal and connective tissue disorders
Gouty tophus
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Musculoskeletal and connective tissue disorders
Haematoma muscle
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.04%
1/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.20%
5/2515 • Number of events 5 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.16%
4/2515 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.16%
4/2519 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.12%
3/2519 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.12%
3/2515 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.12%
3/2515 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.12%
3/2519 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal gland cancer metastatic
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiocentric lymphoma
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign gastric neoplasm
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of bladder
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.16%
4/2515 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cutaneous T-cell lymphoma
|
0.04%
1/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.12%
3/2519 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatobiliary cancer
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Inflammatory pseudotumour
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.16%
4/2515 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoproliferative disorder
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to abdominal cavity
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal cancer
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal squamous cell carcinoma
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Polycythaemia vera
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.20%
5/2515 • Number of events 5 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.12%
3/2519 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Retroperitoneal cancer
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of head and neck
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the oral cavity
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sweat gland tumour
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour ulceration
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Waldenstrom's macroglobulinaemia
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Altered state of consciousness
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Autonomic neuropathy
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Axonal neuropathy
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Brain hypoxia
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Brain injury
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.12%
3/2515 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Cauda equina syndrome
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Cerebral artery embolism
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Cerebral artery stenosis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Cerebral infarction
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Cerebral ischaemia
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Cerebrovascular accident
|
0.12%
3/2519 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.24%
6/2515 • Number of events 6 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Coma
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Dementia
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Dizziness
|
0.24%
6/2519 • Number of events 6 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Headache
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Hemiparesis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Ischaemic stroke
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Lethargy
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Myelopathy
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Neuropathy peripheral
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Post stroke epilepsy
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Presyncope
|
0.16%
4/2519 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Sciatica
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Seizure
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Status epilepticus
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Syncope
|
1.7%
43/2519 • Number of events 45 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
1.3%
33/2515 • Number of events 35 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Tension headache
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Transient ischaemic attack
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Vascular dementia
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Product Issues
Device battery issue
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.16%
4/2515 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Product Issues
Device dislocation
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Product Issues
Device failure
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Product Issues
Device ineffective
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Product Issues
Device malfunction
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.16%
4/2515 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Product Issues
Lead dislodgement
|
0.04%
1/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Psychiatric disorders
Anxiety
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Psychiatric disorders
Confusional state
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Psychiatric disorders
Delirium
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.12%
3/2515 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Psychiatric disorders
Depression
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Psychiatric disorders
Drug use disorder
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Psychiatric disorders
Panic attack
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Psychiatric disorders
Suicide attempt
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Renal and urinary disorders
Acute kidney injury
|
2.6%
66/2519 • Number of events 69 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
2.0%
51/2515 • Number of events 53 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Renal and urinary disorders
Bladder cyst
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Renal and urinary disorders
Bladder mass
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Renal and urinary disorders
Calculus bladder
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.6%
40/2519 • Number of events 42 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
1.2%
31/2515 • Number of events 31 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Renal and urinary disorders
Costovertebral angle tenderness
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Renal and urinary disorders
End stage renal disease
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Renal and urinary disorders
Haematuria
|
0.12%
3/2519 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.28%
7/2515 • Number of events 7 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Renal and urinary disorders
Nephropathy
|
0.12%
3/2519 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Renal and urinary disorders
Renal colic
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Renal and urinary disorders
Renal cyst
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Renal and urinary disorders
Renal failure
|
0.95%
24/2519 • Number of events 25 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
1.2%
30/2515 • Number of events 31 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Renal and urinary disorders
Renal impairment
|
0.24%
6/2519 • Number of events 6 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.28%
7/2515 • Number of events 7 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Renal and urinary disorders
Renal infarct
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Renal and urinary disorders
Renal mass
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Renal and urinary disorders
Urate nephropathy
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Renal and urinary disorders
Urinary retention
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.32%
8/2515 • Number of events 8 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.16%
4/2519 • Number of events 5 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.36%
9/2519 • Number of events 9 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.28%
7/2515 • Number of events 7 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.24%
6/2519 • Number of events 6 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.16%
4/2515 • Number of events 6 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial haemorrhage
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.5%
38/2519 • Number of events 51 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
1.2%
30/2515 • Number of events 50 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.44%
11/2519 • Number of events 11 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.28%
7/2515 • Number of events 7 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.12%
3/2515 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.24%
6/2519 • Number of events 8 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.52%
13/2515 • Number of events 15 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.24%
6/2519 • Number of events 7 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.16%
4/2515 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.16%
4/2519 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.24%
6/2515 • Number of events 6 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haematoma
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.16%
4/2519 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.12%
3/2515 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.12%
3/2519 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.20%
5/2515 • Number of events 5 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis hypertrophic
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar haemorrhage
|
0.04%
1/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.16%
4/2515 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Skin and subcutaneous tissue disorders
Henoch-Schonlein purpura
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.20%
5/2519 • Number of events 5 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.36%
9/2515 • Number of events 14 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Surgical and medical procedures
Aortic aneurysm repair
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Surgical and medical procedures
Arrhythmia prophylaxis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Surgical and medical procedures
Cardiac pacemaker replacement
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Surgical and medical procedures
Cardiac rehabilitation therapy
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Surgical and medical procedures
Cardiac resynchronisation therapy
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.28%
7/2515 • Number of events 7 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Surgical and medical procedures
Cardiovascular event prophylaxis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.16%
4/2515 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Surgical and medical procedures
Cardioversion
|
0.04%
1/2519 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Surgical and medical procedures
Central venous catheter removal
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Surgical and medical procedures
Gastrectomy
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Surgical and medical procedures
Implantable defibrillator insertion
|
0.20%
5/2519 • Number of events 5 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Surgical and medical procedures
Implantable defibrillator removal
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Surgical and medical procedures
Implantable defibrillator replacement
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Surgical and medical procedures
Intraocular lens implant
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Surgical and medical procedures
Leg amputation
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Surgical and medical procedures
Nephroprotective therapy
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Surgical and medical procedures
Therapeutic procedure
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Surgical and medical procedures
Toe operation
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Aortic aneurysm
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Aortic dissection
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Aortic stenosis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Bleeding varicose vein
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Deep vein thrombosis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Diabetic vascular disorder
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Dry gangrene
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Extremity necrosis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Haematoma
|
0.16%
4/2519 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Haemorrhagic vasculitis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Hypertension
|
0.20%
5/2519 • Number of events 5 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.16%
4/2515 • Number of events 4 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Hypertensive crisis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.20%
5/2515 • Number of events 5 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Hypotension
|
1.3%
33/2519 • Number of events 34 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
1.7%
44/2515 • Number of events 45 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Hypovolaemic shock
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Iliac artery occlusion
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Intermittent claudication
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Ischaemia
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Lymphorrhoea
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Orthostatic hypotension
|
0.24%
6/2519 • Number of events 6 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.24%
6/2519 • Number of events 6 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.44%
11/2515 • Number of events 12 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Peripheral artery occlusion
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Peripheral artery stenosis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Peripheral embolism
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Peripheral ischaemia
|
0.08%
2/2519 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.12%
3/2515 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Peripheral vascular disorder
|
0.16%
4/2519 • Number of events 6 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.12%
3/2515 • Number of events 3 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Peripheral venous disease
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Shock
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.04%
1/2515 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/2519 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Thrombophlebitis
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.08%
2/2515 • Number of events 2 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Varicose vein
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Varicose vein ruptured
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Vascular occlusion
|
0.04%
1/2519 • Number of events 1 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
0.00%
0/2515 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
Other adverse events
| Measure |
Vericiguat
n=2519 participants at risk
Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily with food, on a background of HF standard of care. The vericiguat dose was uptitrated to 5 mg and to 10 mg.
|
Placebo
n=2515 participants at risk
Participants received a starting matching placebo dose of 2.5 mg taken orally once daily with food, on a background of HF standard of care. The matching placebo dose was uptitrated to 5 mg and to 10 mg.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.6%
165/2519 • Number of events 181 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
5.3%
134/2515 • Number of events 139 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Cardiac disorders
Cardiac failure
|
6.4%
160/2519 • Number of events 219 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
6.2%
157/2515 • Number of events 221 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
127/2519 • Number of events 141 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
4.8%
120/2515 • Number of events 136 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
126/2519 • Number of events 153 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
5.2%
131/2515 • Number of events 163 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.4%
112/2519 • Number of events 124 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
5.5%
138/2515 • Number of events 167 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Nervous system disorders
Dizziness
|
6.7%
169/2519 • Number of events 195 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
6.0%
152/2515 • Number of events 169 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
127/2519 • Number of events 161 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
5.2%
132/2515 • Number of events 158 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
|
Vascular disorders
Hypotension
|
14.6%
369/2519 • Number of events 487 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
13.2%
331/2515 • Number of events 437 • Up to approximately 35 months (through Last Subject Last Visit date of 02-Sept-2019)
Serious Adverse Events and Other Adverse Events: All randomized participants who received at least 1 dose of study treatment All-Cause Mortality: All randomized participants
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER