Trial Outcomes & Findings for The Home INR Study (NCT NCT00032591)

NCT ID: NCT00032591

Last Updated: 2014-04-15

Results Overview

Time to first event (death, stroke, major bleed) The primary outcome was time to first event, and we used the Kaplan-Meier method to compare survival curves and the results using the log-rank test. The number of patients with a primary outcome is what was reported in the NEJM paper. Below is the unpublished cumulative incidence information.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

2922 participants

Primary outcome timeframe

Time to event

Results posted on

2014-04-15

Participant Flow

Recruitment started in August 2003 and ended at the end of May 2006. Participating sites were VA Medical Centers with anticoagulation services with active rosters of more than 400 patients.

A total of 3745 participants were consented and screened. Out of this total, 823 were excluded from the study. The majority of those excluded is due to participants not doing or passing the competency assessment.

Participant milestones

Participant milestones
Measure	Patient Self-Testing (PST) Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing	High Quality Anticoagulation Management (HQACM) High quality anticoagulation management (HQACM) with conventional monthly testing
Screening STARTED	1873	1872
Screening COMPLETED	1465	1457
Screening NOT COMPLETED	408	415
Randomization STARTED	1465	1457
Randomization COMPLETED	1465	1457
Randomization NOT COMPLETED	0	0
Follow-up STARTED	1465	1457
Follow-up COMPLETED	1463	1452
Follow-up NOT COMPLETED	2	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Home INR Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patient Self-Testing (PST) n=1465 Participants Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing	High Quality Anticoagulation Management (HQACM) n=1457 Participants High quality anticoagulation management (HQACM) with conventional monthly testing	Total n=2922 Participants Total of all reporting groups
Age, Continuous Total study population	66.6 years STANDARD_DEVIATION 9.7 • n=5 Participants	67.4 years STANDARD_DEVIATION 9.4 • n=7 Participants	67 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	26 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	1440 Participants n=5 Participants	1431 Participants n=7 Participants	2871 Participants n=5 Participants

PRIMARY outcome

Timeframe: Time to event

Population: Randomized participants with at least one day of follow-up, per intent to treat

Time to first event (death, stroke, major bleed) The primary outcome was time to first event, and we used the Kaplan-Meier method to compare survival curves and the results using the log-rank test. The number of patients with a primary outcome is what was reported in the NEJM paper. Below is the unpublished cumulative incidence information.

Outcome measures

Outcome measures
Measure	Patient Self-Testing (PST) n=1463 Participants Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing	High Quality Anticoagulation Management (HQACM) n=1452 Participants High quality anticoagulation management (HQACM) with conventional monthly testing
Time to First Event (Death, Stroke, Major Bleed) Cumulative Incidence at 500 Days	0.0785 cumulative probability of event Interval 0.0645 to 0.0925	0.0987 cumulative probability of event Interval 0.083 to 0.1144
Time to First Event (Death, Stroke, Major Bleed) Cumulative Incidence at 1000 Days	0.1542 cumulative probability of event Interval 0.1349 to 0.1734	0.1820 cumulative probability of event Interval 0.161 to 0.2031
Time to First Event (Death, Stroke, Major Bleed) Cumulative Incidence at 1500 Days	0.2268 cumulative probability of event Interval 0.2002 to 0.2535	0.2524 cumulative probability of event Interval 0.2229 to 0.2818

SECONDARY outcome

Timeframe: Full length of follow-up; average of 3 years

Population: Randomized participants with at least one day of follow-up, per intent to treat

Time in target range (TTR) based on Prothrombin Time standardized to the International Normalized Ratio

Outcome measures

Outcome measures
Measure	Patient Self-Testing (PST) n=1463 Participants Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing	High Quality Anticoagulation Management (HQACM) n=1452 Participants High quality anticoagulation management (HQACM) with conventional monthly testing
Time in Therapeutic Range Over Full Length of Follow-up (0 to 100 Percent)	66.2 percentage Standard Deviation 14.2	62.4 percentage Standard Deviation 17.1

SECONDARY outcome

Timeframe: At two years of follow-up

Population: Randomized participants with at least one day of follow-up, per intent to treat

Satisfaction with care was quantified using the Duke Anticoagulation Satisfaction Scale (DASS). Scores range from 25 to 225, with lower scores indicating higher satisfaction.

Outcome measures

Outcome measures
Measure	Patient Self-Testing (PST) n=1120 Participants Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing	High Quality Anticoagulation Management (HQACM) n=929 Participants High quality anticoagulation management (HQACM) with conventional monthly testing
DASS at 2 Years of Follow-up	46.8 score Standard Deviation 16.3	49.2 score Standard Deviation 18.0

SECONDARY outcome

Timeframe: After 2 years of follow-up for each subject

Population: Randomized participants with at least one day of follow-up, per intent to treat

Scores range from -0.36 to 1.00 per year, with a negative score indicating a state worse than being dead and a score of 1.00 indicating perfect health. Since the time frame is 2 years, the range is -0.72 to 2.00.

Outcome measures

Outcome measures
Measure	Patient Self-Testing (PST) n=1183 Participants Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing	High Quality Anticoagulation Management (HQACM) n=997 Participants High quality anticoagulation management (HQACM) with conventional monthly testing
Cumulative Gain in Health Utilities at 2 Year	1.204 score Standard Deviation 0.619	1.049 score Standard Deviation 0.575

SECONDARY outcome

Timeframe: After 2 years of follow-up for each subject

Population: Randomized participants with at least one day of follow-up, per intent to treat

Outcome measures

Outcome measures
Measure	Patient Self-Testing (PST) n=1463 Participants Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing	High Quality Anticoagulation Management (HQACM) n=1452 Participants High quality anticoagulation management (HQACM) with conventional monthly testing
Health Care Costs at 2 Year	25,754 U.S. Dollars Standard Deviation 35,673	24,505 U.S. Dollars Standard Deviation 31,827

Adverse Events

Patient Self-Testing (PST)

Serious events: 247 serious events

Other events: 399 other events

Deaths: 0 deaths

High Quality Anticoagulation Management (HQACM)

Serious events: 250 serious events

Other events: 332 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Patient Self-Testing (PST) n=1465 participants at risk Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing	High Quality Anticoagulation Management (HQACM) n=1457 participants at risk High quality anticoagulation management (HQACM) with conventional monthly testing
Infections and infestations Endocarditis staphylococcal	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic carcinoma	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Nervous system disorders Cerebral hemorrhage	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Nervous system disorders Cerebrovascular accident	0.48% 7/1465 • Number of events 9 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.69% 10/1457 • Number of events 10 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders "Chronic ischemic heart disease, unspecified"	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukemia	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Renal and urinary disorders Chronic renal failure	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Chronic subdural hematoma	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Collapse of lung	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Congestive heart failure	0.75% 11/1465 • Number of events 11 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.96% 14/1457 • Number of events 14 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Respiratory, thoracic and mediastinal disorders COPD	0.34% 5/1465 • Number of events 5 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.34% 5/1457 • Number of events 5 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Respiratory, thoracic and mediastinal disorders COPD exacerbation	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Cor pulmonale	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Surgical and medical procedures Coronary artery bypass	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Coronary artery disease	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.14% 2/1457 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Coronary artery occlusion	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
General disorders Death	1.5% 22/1465 • Number of events 22 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	1.3% 19/1457 • Number of events 19 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Vascular disorders Deep vein thrombosis	0.07% 1/1465 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Diarrhea	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Vascular disorders Dissecting aortic aneurysm	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Diverticulitis intestinal hemorrhagic	0.27% 4/1465 • Number of events 4 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Diverticulum intestinal hemorrhagic	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
General disorders Drug interaction	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Duodenal perforation	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Nervous system disorders Embolic stroke	0.14% 2/1465 • Number of events 3 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Vascular disorders Embolus	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders End stage heart disease	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Infections and infestations Endocarditis	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.34% 5/1465 • Number of events 5 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.21% 3/1457 • Number of events 3 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Esophageal cancer	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Esophageal hemorrhage	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Esophagitis	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Explosion injury	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Eye disorders Eye hemorrhage	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Fall	0.20% 3/1465 • Number of events 3 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Vascular disorders Femoral artery occlusion	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Gastric bleeding	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Gastritis	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Gastroesophageal junction ulcer	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Gastrointestinal ulcer bleeding	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 4/1457 • Number of events 4 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders GI bleed	1.6% 24/1465 • Number of events 30 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	2.3% 33/1457 • Number of events 50 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Gum bleeding	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Heart failure	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.34% 5/1457 • Number of events 5 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Musculoskeletal and connective tissue disorders Hemarthrosis	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Vascular disorders Hematoma	0.41% 6/1465 • Number of events 6 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 4/1457 • Number of events 4 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Musculoskeletal and connective tissue disorders Hematoma muscle	0.20% 3/1465 • Number of events 3 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.14% 2/1457 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Renal and urinary disorders Hematuria	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.34% 5/1457 • Number of events 5 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Hematuria traumatic	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Respiratory, thoracic and mediastinal disorders Hemopneumothorax	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Respiratory, thoracic and mediastinal disorders Hemoptysis	0.20% 3/1465 • Number of events 3 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Hemorrhage intraperitoneal	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Vascular disorders Hemorrhagic shock	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Nervous system disorders Hemorrhagic stroke	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Nervous system disorders Hemorrhagic transformation stroke	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hemorrhagic tumor necrosis	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Hemorrhoidal bleeding	0.14% 2/1465 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Respiratory, thoracic and mediastinal disorders Hemothorax	0.20% 3/1465 • Number of events 3 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer metastatic	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Hepatobiliary disorders Hepatorenal syndrome	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin*s lymphoma	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Eye disorders Hyphema	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Nervous system disorders Hypoxic brain damage	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Incision site bleeding	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Incision site haematoma	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.14% 2/1457 • Number of events 3 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Infections and infestations Infectious diarrhea	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Inflammatory bowel disease	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Nervous system disorders Intracerebral hemorrhage	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Nervous system disorders Intracranial hematoma	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Nervous system disorders Intracranial hemorrhage	0.20% 3/1465 • Number of events 3 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Intraoperative bleeding	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Ischemic cardiomyopathy	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.14% 2/1457 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Musculoskeletal and connective tissue disorders Joint bleeding	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Nervous system disorders Lacunar infarction	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukemia	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukemia myelogenous	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) "Liver, cancer of"	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.14% 2/1465 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer	0.14% 2/1465 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.14% 2/1457 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Infections and infestations Lung infection	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Respiratory, thoracic and mediastinal disorders Lung mass	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Mallory Weiss tear	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Respiratory, thoracic and mediastinal disorders Mediastinal hematoma	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Infections and infestations Mediastinitis	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Melena	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic colon cancer	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic disease	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) "Metastatic neoplasm NOS, primary site unknown"	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Nervous system disorders Middle cerebral artery stroke	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Nervous system disorders Middle cerebral artery thrombosis	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Motor cycling accident	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Motor vehicle accident	0.20% 3/1465 • Number of events 3 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
General disorders Multi organ failure	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Myocardial infarction	0.48% 7/1465 • Number of events 7 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.41% 6/1457 • Number of events 6 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma of the skin	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Infections and infestations Neutropenic sepsis	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Non-Q wave MI	0.27% 4/1465 • Number of events 5 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Infections and infestations Nosocomial pneumonia	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Investigations Occult blood positive	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic adenocarcinoma metastatic	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic cancer	0.14% 2/1465 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic cancer metastatic	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Reproductive system and breast disorders Pelvic hematoma	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Perforation post colonoscopy	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Surgical and medical procedures Pneumonectomy	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Infections and infestations Pneumonia	0.34% 5/1465 • Number of events 5 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.41% 6/1457 • Number of events 6 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Infections and infestations Pneumonia MRSA	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Surgical and medical procedures Polypectomy	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.14% 2/1457 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Hepatobiliary disorders Portal vein thrombosis	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Post biopsy bleeding	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.21% 3/1457 • Number of events 3 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Post procedural bleeding	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Postoperative bleeding	0.14% 2/1465 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.14% 2/1457 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Postoperative complication	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Infections and infestations Pyelonephritis	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Q wave MI	0.14% 2/1465 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Radiation esophagitis	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Radiation pneumonitis	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Rectal bleeding	0.20% 3/1465 • Number of events 3 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.34% 5/1457 • Number of events 5 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Renal and urinary disorders Renal artery aneurysm	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Renal and urinary disorders Renal failure	0.14% 2/1465 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.14% 2/1465 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.34% 5/1457 • Number of events 5 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Eye disorders Retinal artery occlusion	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Eye disorders Retinal hemorrhage	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Retroperitoneal bleed	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.14% 2/1457 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Ruptured appendix	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Nervous system disorders Ruptured cerebral aneurysm	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Ruptured diverticulum	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcoma	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Infections and infestations Scrotal abscess	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Infections and infestations Sepsis	0.41% 6/1465 • Number of events 6 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.34% 5/1457 • Number of events 5 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Infections and infestations Septic shock	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.14% 2/1457 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer metastatic	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.14% 2/1457 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Stoma site bleeding	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Strangulated hernia	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Nervous system disorders Subarachnoid hemorrhage	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.14% 2/1457 • Number of events 3 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Subdural hematoma	0.14% 2/1465 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.48% 7/1457 • Number of events 7 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
General disorders Sudden cardiac death	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.14% 2/1457 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
General disorders Sudden death	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Psychiatric disorders Suicide	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Vascular disorders Thromboembolism	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Tongue hematoma	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Nervous system disorders Transient ischaemic attack	0.61% 9/1465 • Number of events 9 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.62% 9/1457 • Number of events 10 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Nervous system disorders Transient ischemic attacks	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Traumatic hematoma	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.14% 2/1457 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Traumatic hemorrhage	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders UGI bleed	0.27% 4/1465 • Number of events 4 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 4/1457 • Number of events 4 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Unknown primary cancer	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Respiratory, thoracic and mediastinal disorders Unspecified disease of respiratory system	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.14% 2/1457 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Infections and infestations Urosepsis	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Vascular disorders Vascular pseudoaneurysm	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Ventricular arrhythmia	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.14% 2/1457 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Ventricular fibrillation	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.14% 2/1457 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Ventricular tachycardia	0.14% 2/1465 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Eye disorders Vitreous hemorrhage	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Vascular disorders Arterial hemorrhage	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Vascular disorders Arteriosclerotic cardiovascular disease	0.20% 3/1465 • Number of events 3 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Vascular disorders Abdominal aortic aneurysm	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Abdominal hematoma	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute leukemia	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukemia	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Acute myocardial infarction	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Nervous system disorders Anoxic encephalopathy	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Vascular disorders Aortic aneurysm rupture	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Vascular disorders Aortic dissection	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Respiratory, thoracic and mediastinal disorders ARDS	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Vascular disorders Arterial embolism limb	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Arteriovenous fistula site bleeding	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 4 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Congenital, familial and genetic disorders Arteriovenous malformations	0.14% 2/1465 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.14% 2/1457 • Number of events 3 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Respiratory, thoracic and mediastinal disorders Aspiration pneumonia	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Asystole	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Vascular disorders Atherosclerotic cardiovascular disease	0.14% 2/1465 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.21% 3/1457 • Number of events 3 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder squamous cell carcinoma	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Vascular disorders Bleeding	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Bleeding esophageal ulcer	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Bleeding gastric ulcer	0.14% 2/1465 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Nervous system disorders Bleeding intracranial	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Renal and urinary disorders Blood clot in urine	0.07% 1/1465 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Bowel infarction	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Brain herniation	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Nervous system disorders Brain stem hemorrhage	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain tumor	0.14% 2/1465 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Infections and infestations Bronchitis	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoma duodenum	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoma vocal cord	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Cardiac arrest	0.27% 4/1465 • Number of events 4 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.21% 3/1457 • Number of events 3 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Cardiac arrhythmia	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
General disorders Cardiac death	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Cardiac failure	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Cardiac ischemia	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Cardiac procedure complication	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Cardiac valve replacement complication	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Cardiogenic shock	0.14% 2/1465 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Cardiopulmonary arrest	0.14% 2/1465 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Vascular disorders Cardiovascular collapse	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Infections and infestations Cellulitis of hand	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Infections and infestations Cellulitis of leg	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Nervous system disorders Cerebellar hemorrhage	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Nervous system disorders Cerebral hematoma	0.14% 2/1465 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).

Other adverse events

Other adverse events
Measure	Patient Self-Testing (PST) n=1465 participants at risk Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing	High Quality Anticoagulation Management (HQACM) n=1457 participants at risk High quality anticoagulation management (HQACM) with conventional monthly testing
Injury, poisoning and procedural complications Abrasions	0.14% 2/1465 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Blood and lymphatic system disorders Anemia	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Anemia postoperative	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.14% 2/1457 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Arteriovenous graft site hemorrhage	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 4 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Congenital, familial and genetic disorders Arteriovenous malformation	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Vascular disorders Bleeding	2.2% 32/1465 • Number of events 45 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	1.9% 27/1457 • Number of events 31 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Ear and labyrinth disorders Bleeding from ears	0.27% 4/1465 • Number of events 4 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.48% 7/1457 • Number of events 7 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Bleeding from tongue	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.14% 2/1457 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Bleeding gastric ulcer	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Reproductive system and breast disorders Bleeding genital	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Bleeding lips	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 4/1457 • Number of events 4 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Bleeding mouth	0.34% 5/1465 • Number of events 5 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.21% 3/1457 • Number of events 3 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Renal and urinary disorders Bleeding urogenital	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Vascular disorders Bleeding varicose vein	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Blood in stool	0.34% 5/1465 • Number of events 5 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.34% 5/1457 • Number of events 5 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Bruising	0.48% 7/1465 • Number of events 8 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 4/1457 • Number of events 5 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
General disorders Catheter site bleeding	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.14% 2/1457 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
General disorders Catheter site hematoma	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Infections and infestations Cellulitis of finger	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Infections and infestations Cellulitis of leg	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
General disorders Central line complication	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Nervous system disorders Cerebral infarction	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Surgical and medical procedures Circumcision	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.14% 2/1457 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Eye disorders Conjunctival bleeding	0.27% 4/1465 • Number of events 4 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.21% 3/1457 • Number of events 3 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Eye disorders Corneal bleeding	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Investigations Cystoscopy	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Vascular disorders Deep venous thrombosis arm	0.14% 2/1465 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.14% 2/1457 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Vascular disorders Deep venous thrombosis femoral	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Diverticulosis	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Dog bite	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Vascular disorders DVT	0.14% 2/1465 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.55% 8/1457 • Number of events 8 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Skin and subcutaneous tissue disorders Ecchymosis	0.82% 12/1465 • Number of events 21 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Respiratory, thoracic and mediastinal disorders Effusion pleural bloody	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Vascular disorders Embolus arm	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Respiratory, thoracic and mediastinal disorders Epistaxis	5.4% 79/1465 • Number of events 130 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	4.3% 63/1457 • Number of events 88 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Eye disorders Eye hemorrhage	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Investigations Fecal occult blood	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Femoral artery injury	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Foot injury	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Skin and subcutaneous tissue disorders Foot ulcer	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Hepatobiliary disorders Gallbladder hemorrhage	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Gastritis	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Congenital, familial and genetic disorders Gastrointestinal arteriovenous malformation	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders GI bleed	1.8% 27/1465 • Number of events 28 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	1.2% 18/1457 • Number of events 19 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Gingival bleeding	0.20% 3/1465 • Number of events 3 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.48% 7/1457 • Number of events 7 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Nervous system disorders Haemorrhagic transformation stroke	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Musculoskeletal and connective tissue disorders Hemarthrosis	0.14% 2/1465 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Hematemesis	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Hematochezia	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.21% 3/1457 • Number of events 3 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Vascular disorders Hematoma	1.7% 25/1465 • Number of events 25 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.96% 14/1457 • Number of events 14 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Musculoskeletal and connective tissue disorders Hematoma muscle	0.14% 2/1465 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Reproductive system and breast disorders Hematospermia	0.41% 6/1465 • Number of events 7 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Renal and urinary disorders Hematuria	4.6% 67/1465 • Number of events 89 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	3.7% 54/1457 • Number of events 72 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Hemoperitoneum	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Respiratory, thoracic and mediastinal disorders Hemoptysis	0.75% 11/1465 • Number of events 13 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	1.2% 17/1457 • Number of events 19 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Respiratory, thoracic and mediastinal disorders Hemorrhage from throat	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Skin and subcutaneous tissue disorders Hemorrhage subcutaneous	0.20% 3/1465 • Number of events 3 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Nervous system disorders Hemorrhagic stroke	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.14% 2/1457 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Nervous system disorders Hemorrhagic transformation stroke	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Hemorrhoidal bleeding	0.68% 10/1465 • Number of events 13 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.62% 9/1457 • Number of events 10 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Respiratory, thoracic and mediastinal disorders Hemothorax	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Surgical and medical procedures Ileostomy	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Incision site bleeding	0.55% 8/1465 • Number of events 8 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.21% 3/1457 • Number of events 3 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Incision site hematoma	0.14% 2/1465 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.14% 2/1457 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
General disorders Injection site bleeding	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.14% 2/1457 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Intracardiac thrombus	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Nervous system disorders Intracranial hemorrhage	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Eye disorders Intraocular hemorrhage	0.48% 7/1465 • Number of events 7 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.14% 2/1457 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Intraoperative bleeding	0.55% 8/1465 • Number of events 9 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.82% 12/1457 • Number of events 12 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Musculoskeletal and connective tissue disorders Joint bleeding	0.20% 3/1465 • Number of events 3 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Musculoskeletal and connective tissue disorders Joint hematoma	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Laceration	1.3% 19/1465 • Number of events 20 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.82% 12/1457 • Number of events 12 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Limb injury	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Mallory Weiss tear	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Melena	0.14% 2/1465 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.14% 2/1457 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Musculoskeletal and connective tissue disorders Muscle hemorrhage	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.14% 2/1457 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplasia	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Myocardial infarction	0.27% 4/1465 • Number of events 4 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Non-Q wave MI	1.3% 19/1465 • Number of events 19 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	1.2% 18/1457 • Number of events 18 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Eye disorders Ocular retrobulbar hemorrhage	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Perforation post colonoscopy	0.14% 2/1465 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Respiratory, thoracic and mediastinal disorders Pleural hemorrhage	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Infections and infestations Pneumonia	0.14% 2/1465 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Post biopsy bleeding	0.27% 4/1465 • Number of events 4 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.21% 3/1457 • Number of events 3 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Post procedural bleeding	0.89% 13/1465 • Number of events 13 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.48% 7/1457 • Number of events 9 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Postoperative bleeding	0.61% 9/1465 • Number of events 9 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	1.0% 15/1457 • Number of events 15 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Postoperative hematoma	0.34% 5/1465 • Number of events 5 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.14% 2/1457 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.20% 3/1465 • Number of events 3 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.34% 5/1457 • Number of events 5 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Cardiac disorders Q wave MI	0.14% 2/1465 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.21% 3/1457 • Number of events 3 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Rectal bleeding	2.2% 32/1465 • Number of events 39 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	2.4% 35/1457 • Number of events 40 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Renal and urinary disorders Renal artery embolism	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Respiratory, thoracic and mediastinal disorders Respiratory tract hemorrhage	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Eye disorders Retinal vein occlusion	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders Retroperitoneal bleed	0.55% 8/1465 • Number of events 10 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.27% 4/1457 • Number of events 4 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Eye disorders Scleral hemorrhage	0.14% 2/1465 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.14% 2/1457 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Scrotal hematoma	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Reproductive system and breast disorders Scrotal hemorrhage	0.14% 2/1465 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Nervous system disorders Stroke	1.6% 24/1465 • Number of events 29 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	2.3% 34/1457 • Number of events 41 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Eye disorders Subconjunctival hemorrhage	0.68% 10/1465 • Number of events 11 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.14% 2/1457 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Reproductive system and breast disorders Testicular hemorrhage	0.07% 1/1465 • Number of events 2 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Traumatic hematoma	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Gastrointestinal disorders UGI bleed	0.27% 4/1465 • Number of events 4 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.34% 5/1457 • Number of events 6 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Renal and urinary disorders Urethral hemorrhage	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Renal and urinary disorders Urinary tract bleeding	0.55% 8/1465 • Number of events 11 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.62% 9/1457 • Number of events 9 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Infections and infestations Urinary tract infection	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Venous injury	0.07% 1/1465 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.00% 0/1457 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Eye disorders Vitreous hemorrhage	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/1465 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).	0.07% 1/1457 • Number of events 1 • Full length of follow-up Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT).

Additional Information

Bob Edson

Palo Alto CSPCC

Phone: (650) 493-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place