THINRS: The Home INR Study
Sponsor
US Department of Veterans Affairs (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00032591
Collaborator
(none)
2,922
29
2
57
100.8
1.8
Study Details
Study Description
Brief Summary
Since home monitors of prothrombin time (PT) may potentially improve the safety, quality, and convenience of chronic anticoagulation management, it is likely that there will be demands from providers, patients, and manufacturers to make home monitors available to VA patients. The rationale for patient self-testing (PST) is that, compared to conventional high quality anticoagulation management (HQACM), it would permit more intense monitoring and increased patient participation in his/her own care, resulting in increased precision in anticoagulation control and thus fewer events of thromboembolism (strokes) and bleeding. The secondary hypothesis is that PST and HQACM will be comparable in terms of health care utilization and cost.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
Intervention: Weekly patient self-testing (PST) of prothrombin time by international normalized ratio (PT INR) versus conventional monthly high quality anticoagulation management (HQACM) from an anticoagulation clinic with a minimum two years follow-up.
Primary Hypothesis: Compared to conventional monitoring in the clinic, PST of anticoagulation intensity will decrease the number of events of thromboembolism (strokes), bleeding, and all cause deaths and improve the quality of anticoagulation.
Second Hypothesis: PST and conventional monitoring will be comparable in terms of health care utilization and cost.
Primary Outcomes: Event rates (thromboembolism or bleeding episodes), time to first event, time within therapeutic range for anticoagulation intensity, and total health care cost (including price of PST monitors) and utilization.
Study Abstract: Since home monitors of prothrombin time (PT) may potentially improve the safety, quality, and convenience of chronic anticoagulation management, it is likely that there will be demands from providers, patients, and manufacturers to make home monitors available to VA patients. The rationale for PST is that it would permit more intense monitoring and increased patient participation in his/her own care, resulting in increased precision in anticoagulation control and thus fewer events.
Original plan was for a study at 32 sites with a total sample size of about 3,200 patients and a length of three years (one for recruitment and two years of follow-up). Final status was 28 sites that randomized 2922 patients in 2.75 years of recruitment with a minimum of two years of follow-up.
Study Design
Study Type:
Interventional
Actual Enrollment
:
2922 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
CSP #481 - The Home INR Study (THINRS)
Study Start Date
:
Aug 1, 2003
Actual Primary Completion Date
:
May 1, 2008
Actual Study Completion Date
:
May 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Arm 1 Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing |
Procedure: Weekly patient self-testing of prothrombin time
|
| Other: Arm 2 High quality anticoagulation management (HQACM) with conventional monthly testing |
Other: High quality anticoagulation management (HQACM) with conventional monthly testing
HQACM with testing every 4 weeks and as indicated for out of range values, medication/clinical changes.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Time to First Event (Death, Stroke, Major Bleed) [Time to event]
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.
Secondary Outcome Measures
- Time in Therapeutic Range Over Full Length of Follow-up (0 to 100 Percent) [Full length of follow-up; average of 3 years]
Time in target range (TTR) based on Prothrombin Time standardized to the International Normalized Ratio
- DASS at 2 Years of Follow-up [At two years of follow-up]
Satisfaction with care was quantified using the Duke Anticoagulation Satisfaction Scale (DASS). Scores range from 25 to 225, with lower scores indicating higher satisfaction.
- Cumulative Gain in Health Utilities at 2 Year [After 2 years of follow-up for each subject]
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.
- Health Care Costs at 2 Year [After 2 years of follow-up for each subject]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
To be enrolled in this study, patients must:
-
have AF and/or a MHV;
-
be scheduled to receive warfarin indefinitely (operationally defined as 2 years);
-
be using warfarin according to the criteria described in the Coumadin package insert (no off-label uses);
-
be expected to survive for the duration of the study;
-
not be suffering from intracranial bleeding (intracranial hemorrhage, subarachnoid hemorrhage, hemorrhagic stroke) or any other contraindication described in the Coumadin package insert;
-
be willing to perform PST;
-
be willing to be randomized;
-
possess adequate cognitive and language skills to follow the protocol and all related instructions;
-
be willing to participate for the full duration of the study;
-
sign the informed consent form; and
-
not be enrolled in another randomized clinical trial that involves a drug or device intervention.
Exclusion Criteria:
Patients are excluded in this study if:
-
subject has had intracranial hemorrhage, subarachnoid hemorrhage, hemorrhagic stroke, or any other absolute/major contraindication described in the warfarin package insert within the last month
-
subject enrolled in another randomized clinical trial that involves a drug or device intervention
-
subject is not able to follow the protocol and all related instructions, and does not have a caregiver with these skills
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA Medical Center, Birmingham | Birmingham | Alabama | United States | 35233 |
| 2 | VA Central California Health Care System, Fresno | Fresno | California | United States | 93703 |
| 3 | VA Medical Center, Loma Linda | Loma Linda | California | United States | 92357 |
| 4 | VA Palo Alto Health Care System | Palo Alto | California | United States | 94304-1290 |
| 5 | VA Greater Los Angeles Healthcare System, West LA | West Los Angeles | California | United States | 90073 |
| 6 | VA Eastern Colorado Health Care System, Denver | Denver | Colorado | United States | 80220 |
| 7 | VA Connecticut Health Care System (West Haven) | West Haven | Connecticut | United States | 06516 |
| 8 | Edward Hines, Jr. VA Hospital | Hines | Illinois | United States | 60141-5000 |
| 9 | VA Medical Center, North Chicago | North Chicago | Illinois | United States | 60064 |
| 10 | VA Medical Center, Iowa City | Iowa City | Iowa | United States | 52246-2208 |
| 11 | VA Maryland Health Care System, Baltimore | Baltimore | Maryland | United States | 21201 |
| 12 | John D. Dingell VA Medical Center, Detroit | Detroit | Michigan | United States | 48201 |
| 13 | VA Medical Center, Minneapolis | Minneapolis | Minnesota | United States | 55417 |
| 14 | VA Medical Center, Kansas City MO | Kansas City | Missouri | United States | 64128 |
| 15 | Las Vegas | North Las Vegas | Nevada | United States | 89036 |
| 16 | VA Sierra Nevada Health Care System | Reno | Nevada | United States | 89502 |
| 17 | VA Medical Center, Bronx | Bronx | New York | United States | 10468 |
| 18 | VA Western New York Healthcare System at Buffalo | Buffalo | New York | United States | 14215 |
| 19 | VA Medical Center, Syracuse | Syracuse | New York | United States | 13210 |
| 20 | Durham VA Medical Center HSR&D COE | Durham | North Carolina | United States | 27705 |
| 21 | VA Medical Center, Cleveland | Cleveland | Ohio | United States | 44106 |
| 22 | VA Medical Center, Oklahoma City | Oklahoma City | Oklahoma | United States | 73104 |
| 23 | VA Pittsburgh Health Care System | Pittsburgh | Pennsylvania | United States | 15240 |
| 24 | VA Medical Center, Providence | Providence | Rhode Island | United States | 02908 |
| 25 | VA North Texas Health Care System, Dallas | Dallas | Texas | United States | 75216 |
| 26 | VA South Texas Health Care System, San Antonio | San Antonio | Texas | United States | 78229 |
| 27 | VA Medical Center, Salem VA | Salem | Virginia | United States | 24153 |
| 28 | Wlliam S. Middleton Memorial Veterans Hospital, Madison | Madison | Wisconsin | United States | 53705 |
| 29 | VA Medical Center, San Juan | San Juan | Puerto Rico | 00921 |
Sponsors and Collaborators
- US Department of Veterans Affairs
Investigators
- Study Chair: David B. Matchar, MD, Durham VA Medical Center HSR&D COE
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
US Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00032591
Other Study ID Numbers:
- 481
First Posted:
Mar 28, 2002
Last Update Posted:
Apr 15, 2014
Last Verified:
Mar 1, 2014
Keywords provided by US Department of Veterans Affairs
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 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. |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | Patient Self-Testing (PST) | High Quality Anticoagulation Management (HQACM) |
|---|---|---|
| Arm/Group Description | Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing | High quality anticoagulation management (HQACM) with conventional monthly testing |
| Period Title: Screening | ||
| STARTED | 1873 | 1872 |
| COMPLETED | 1465 | 1457 |
| NOT COMPLETED | 408 | 415 |
| Period Title: Screening | ||
| STARTED | 1465 | 1457 |
| COMPLETED | 1465 | 1457 |
| NOT COMPLETED | 0 | 0 |
| Period Title: Screening | ||
| STARTED | 1465 | 1457 |
| COMPLETED | 1463 | 1452 |
| NOT COMPLETED | 2 | 5 |
Baseline Characteristics
| Arm/Group Title | Patient Self-Testing (PST) | High Quality Anticoagulation Management (HQACM) | Total |
|---|---|---|---|
| Arm/Group Description | Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing | High quality anticoagulation management (HQACM) with conventional monthly testing | Total of all reporting groups |
| Overall Participants | 1465 | 1457 | 2922 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Total study population |
66.6
(9.7)
|
67.4
(9.4)
|
67
(9.6)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
25
1.7%
|
26
1.8%
|
51
1.7%
|
| Male |
1440
98.3%
|
1431
98.2%
|
2871
98.3%
|
Outcome Measures
| Title | Time to First Event (Death, Stroke, Major Bleed) |
|---|---|
| Description | 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. |
| Time Frame | Time to event |
Outcome Measure Data
| Analysis Population Description |
|---|
| Randomized participants with at least one day of follow-up, per intent to treat |
| Arm/Group Title | Patient Self-Testing (PST) | High Quality Anticoagulation Management (HQACM) |
|---|---|---|
| Arm/Group Description | Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing | High quality anticoagulation management (HQACM) with conventional monthly testing |
| Measure Participants | 1463 | 1452 |
| Cumulative Incidence at 500 Days |
0.0785
|
0.0987
|
| Cumulative Incidence at 1000 Days |
0.1542
|
0.1820
|
| Cumulative Incidence at 1500 Days |
0.2268
|
0.2524
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Patient Self-Testing (PST), High Quality Anticoagulation Management (HQACM) |
|---|---|---|
| Comments | The null hypothesis was the hazard ratio was equal to 1. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | A target of 363 patients with primary events required to discern a 32% relative drop in annual primary event rates with 90% power (from 5.5% for HQACM to 3.75% for PST) was based on a sample size of 3200 patients with 1 year of enrollment and a minimum of 2 years follow-up. Due to slower than planned enrollment, we randomized 2922 patients over 2.75 years, with a mean follow-up of 3 years. | |
| Statistical Test of Hypothesis | p-Value | 0.14 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.88 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Time in Therapeutic Range Over Full Length of Follow-up (0 to 100 Percent) |
|---|---|
| Description | Time in target range (TTR) based on Prothrombin Time standardized to the International Normalized Ratio |
| Time Frame | Full length of follow-up; average of 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Randomized participants with at least one day of follow-up, per intent to treat |
| Arm/Group Title | Patient Self-Testing (PST) | High Quality Anticoagulation Management (HQACM) |
|---|---|---|
| Arm/Group Description | Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing | High quality anticoagulation management (HQACM) with conventional monthly testing |
| Measure Participants | 1463 | 1452 |
| Mean (Standard Deviation) [percentage] |
66.2
(14.2)
|
62.4
(17.1)
|
| Title | DASS at 2 Years of Follow-up |
|---|---|
| Description | Satisfaction with care was quantified using the Duke Anticoagulation Satisfaction Scale (DASS). Scores range from 25 to 225, with lower scores indicating higher satisfaction. |
| Time Frame | At two years of follow-up |
Outcome Measure Data
| Analysis Population Description |
|---|
| Randomized participants with at least one day of follow-up, per intent to treat |
| Arm/Group Title | Patient Self-Testing (PST) | High Quality Anticoagulation Management (HQACM) |
|---|---|---|
| Arm/Group Description | Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing | High quality anticoagulation management (HQACM) with conventional monthly testing |
| Measure Participants | 1120 | 929 |
| Mean (Standard Deviation) [score] |
46.8
(16.3)
|
49.2
(18.0)
|
| Title | Cumulative Gain in Health Utilities at 2 Year |
|---|---|
| Description | 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. |
| Time Frame | After 2 years of follow-up for each subject |
Outcome Measure Data
| Analysis Population Description |
|---|
| Randomized participants with at least one day of follow-up, per intent to treat |
| Arm/Group Title | Patient Self-Testing (PST) | High Quality Anticoagulation Management (HQACM) |
|---|---|---|
| Arm/Group Description | Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing | High quality anticoagulation management (HQACM) with conventional monthly testing |
| Measure Participants | 1183 | 997 |
| Mean (Standard Deviation) [score] |
1.204
(0.619)
|
1.049
(0.575)
|
| Title | Health Care Costs at 2 Year |
|---|---|
| Description | |
| Time Frame | After 2 years of follow-up for each subject |
Outcome Measure Data
| Analysis Population Description |
|---|
| Randomized participants with at least one day of follow-up, per intent to treat |
| Arm/Group Title | Patient Self-Testing (PST) | High Quality Anticoagulation Management (HQACM) |
|---|---|---|
| Arm/Group Description | Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing | High quality anticoagulation management (HQACM) with conventional monthly testing |
| Measure Participants | 1463 | 1452 |
| Mean (Standard Deviation) [U.S. Dollars] |
25,754
(35,673)
|
24,505
(31,827)
|
Adverse Events
| Time Frame | Full length of follow-up | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Serious Adverse Events (SAEs) and non-serious AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 6.1. The verbatim description was used to classify events by Body System affected (System Organ Class or SOC) and to group using a common medical term (Preferred Term or PT). | |||
| Arm/Group Title | Patient Self-Testing (PST) | High Quality Anticoagulation Management (HQACM) | ||
| Arm/Group Description | Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing | High quality anticoagulation management (HQACM) with conventional monthly testing | ||
All Cause Mortality |
||||
| Patient Self-Testing (PST) | High Quality Anticoagulation Management (HQACM) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Patient Self-Testing (PST) | High Quality Anticoagulation Management (HQACM) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 247/1465 (16.9%) | 250/1457 (17.2%) | ||
| Cardiac disorders | ||||
| Acute myocardial infarction | 1/1465 (0.1%) | 1 | 1/1457 (0.1%) | 1 |
| Asystole | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Cardiac arrest | 4/1465 (0.3%) | 4 | 3/1457 (0.2%) | 3 |
| Cardiac arrhythmia | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Cardiac failure | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Cardiac ischemia | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Cardiogenic shock | 2/1465 (0.1%) | 2 | 0/1457 (0%) | 0 |
| Cardiopulmonary arrest | 2/1465 (0.1%) | 2 | 1/1457 (0.1%) | 1 |
| "Chronic ischemic heart disease, unspecified" | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Congestive heart failure | 11/1465 (0.8%) | 11 | 14/1457 (1%) | 14 |
| Cor pulmonale | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Coronary artery disease | 1/1465 (0.1%) | 1 | 2/1457 (0.1%) | 2 |
| Coronary artery occlusion | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| End stage heart disease | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Heart failure | 0/1465 (0%) | 0 | 5/1457 (0.3%) | 5 |
| Ischemic cardiomyopathy | 1/1465 (0.1%) | 1 | 2/1457 (0.1%) | 2 |
| Myocardial infarction | 7/1465 (0.5%) | 7 | 6/1457 (0.4%) | 6 |
| Non-Q wave MI | 4/1465 (0.3%) | 5 | 0/1457 (0%) | 0 |
| Q wave MI | 2/1465 (0.1%) | 2 | 0/1457 (0%) | 0 |
| Ventricular arrhythmia | 0/1465 (0%) | 0 | 2/1457 (0.1%) | 2 |
| Ventricular fibrillation | 0/1465 (0%) | 0 | 2/1457 (0.1%) | 2 |
| Ventricular tachycardia | 2/1465 (0.1%) | 2 | 0/1457 (0%) | 0 |
| Congenital, familial and genetic disorders | ||||
| Arteriovenous malformations | 2/1465 (0.1%) | 2 | 2/1457 (0.1%) | 3 |
| Eye disorders | ||||
| Eye hemorrhage | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Hyphema | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Retinal artery occlusion | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Retinal hemorrhage | 1/1465 (0.1%) | 1 | 1/1457 (0.1%) | 1 |
| Vitreous hemorrhage | 1/1465 (0.1%) | 1 | 1/1457 (0.1%) | 1 |
| Gastrointestinal disorders | ||||
| Abdominal hematoma | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Bleeding esophageal ulcer | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Bleeding gastric ulcer | 2/1465 (0.1%) | 2 | 1/1457 (0.1%) | 1 |
| Bowel infarction | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Diarrhea | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Diverticulitis intestinal hemorrhagic | 4/1465 (0.3%) | 4 | 1/1457 (0.1%) | 1 |
| Diverticulum intestinal hemorrhagic | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Duodenal perforation | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Esophageal hemorrhage | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Esophagitis | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Gastric bleeding | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Gastritis | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Gastroesophageal junction ulcer | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 2 |
| Gastrointestinal ulcer bleeding | 0/1465 (0%) | 0 | 4/1457 (0.3%) | 4 |
| GI bleed | 24/1465 (1.6%) | 30 | 33/1457 (2.3%) | 50 |
| Gum bleeding | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Hemorrhage intraperitoneal | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Hemorrhoidal bleeding | 2/1465 (0.1%) | 2 | 1/1457 (0.1%) | 1 |
| Inflammatory bowel disease | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Lower gastrointestinal hemorrhage | 2/1465 (0.1%) | 2 | 0/1457 (0%) | 0 |
| Mallory Weiss tear | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Melena | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Perforation post colonoscopy | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Rectal bleeding | 3/1465 (0.2%) | 3 | 5/1457 (0.3%) | 5 |
| Retroperitoneal bleed | 0/1465 (0%) | 0 | 2/1457 (0.1%) | 2 |
| Ruptured appendix | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Ruptured diverticulum | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Strangulated hernia | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Tongue hematoma | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| UGI bleed | 4/1465 (0.3%) | 4 | 4/1457 (0.3%) | 4 |
| Upper gastrointestinal hemorrhage | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| General disorders | ||||
| Cardiac death | 1/1465 (0.1%) | 1 | 1/1457 (0.1%) | 1 |
| Death | 22/1465 (1.5%) | 22 | 19/1457 (1.3%) | 19 |
| Drug interaction | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Multi organ failure | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Sudden cardiac death | 1/1465 (0.1%) | 1 | 2/1457 (0.1%) | 2 |
| Sudden death | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Hepatobiliary disorders | ||||
| Hepatorenal syndrome | 1/1465 (0.1%) | 1 | 1/1457 (0.1%) | 1 |
| Portal vein thrombosis | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Infections and infestations | ||||
| Bronchitis | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Cellulitis of hand | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Cellulitis of leg | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Endocarditis | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Endocarditis staphylococcal | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Infectious diarrhea | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Lung infection | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Mediastinitis | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Neutropenic sepsis | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Nosocomial pneumonia | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Pneumonia | 5/1465 (0.3%) | 5 | 6/1457 (0.4%) | 6 |
| Pneumonia MRSA | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Pyelonephritis | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Scrotal abscess | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Sepsis | 6/1465 (0.4%) | 6 | 5/1457 (0.3%) | 5 |
| Septic shock | 1/1465 (0.1%) | 1 | 2/1457 (0.1%) | 2 |
| Urosepsis | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Arteriovenous fistula site bleeding | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 4 |
| Brain herniation | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Cardiac procedure complication | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Cardiac valve replacement complication | 1/1465 (0.1%) | 1 | 1/1457 (0.1%) | 1 |
| Chronic subdural hematoma | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Collapse of lung | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Explosion injury | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Fall | 3/1465 (0.2%) | 3 | 0/1457 (0%) | 0 |
| Hematuria traumatic | 1/1465 (0.1%) | 1 | 1/1457 (0.1%) | 1 |
| Incision site bleeding | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Incision site haematoma | 1/1465 (0.1%) | 1 | 2/1457 (0.1%) | 3 |
| Intraoperative bleeding | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Motor cycling accident | 1/1465 (0.1%) | 1 | 1/1457 (0.1%) | 1 |
| Motor vehicle accident | 3/1465 (0.2%) | 3 | 0/1457 (0%) | 0 |
| Post biopsy bleeding | 0/1465 (0%) | 0 | 3/1457 (0.2%) | 3 |
| Post procedural bleeding | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Post procedural complication | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Postoperative bleeding | 2/1465 (0.1%) | 2 | 2/1457 (0.1%) | 2 |
| Postoperative complication | 1/1465 (0.1%) | 1 | 1/1457 (0.1%) | 1 |
| Radiation esophagitis | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Radiation pneumonitis | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Stoma site bleeding | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Subdural hematoma | 2/1465 (0.1%) | 2 | 7/1457 (0.5%) | 7 |
| Traumatic hematoma | 1/1465 (0.1%) | 1 | 2/1457 (0.1%) | 2 |
| Traumatic hemorrhage | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Investigations | ||||
| Occult blood positive | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Haemarthrosis | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Hemarthrosis | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Hematoma muscle | 3/1465 (0.2%) | 3 | 2/1457 (0.1%) | 2 |
| Joint bleeding | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Acute leukemia | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Acute myeloid leukemia | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Adenocarcinoma | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Adenocarcinoma gastric | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Bile duct cancer | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Bladder cancer | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Bladder squamous cell carcinoma | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Brain tumor | 2/1465 (0.1%) | 2 | 0/1457 (0%) | 0 |
| Cancer | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Carcinoma duodenum | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Carcinoma vocal cord | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Chronic lymphocytic leukemia | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Colon cancer | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Esophageal cancer | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Gastric cancer | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Hemorrhagic tumor necrosis | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Hepatic cancer metastatic | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Hodgkin*s lymphoma | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Leukemia | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Leukemia myelogenous | 1/1465 (0.1%) | 1 | 1/1457 (0.1%) | 1 |
| "Liver, cancer of" | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Lung cancer | 2/1465 (0.1%) | 2 | 1/1457 (0.1%) | 1 |
| Lung cancer metastatic | 1/1465 (0.1%) | 1 | 2/1457 (0.1%) | 2 |
| Malignant pleural effusion | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Metastatic carcinoma | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Metastatic colon cancer | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Metastatic disease | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Metastatic neoplasm | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| "Metastatic neoplasm NOS, primary site unknown" | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Neuroendocrine carcinoma of the skin | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Non-small cell lung cancer | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Non-small cell lung cancer metastatic | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Pancreatic adenocarcinoma metastatic | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Pancreatic cancer | 2/1465 (0.1%) | 2 | 0/1457 (0%) | 0 |
| Pancreatic cancer metastatic | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Prostate cancer | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Sarcoma | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Small cell lung cancer metastatic | 1/1465 (0.1%) | 1 | 2/1457 (0.1%) | 2 |
| Squamous cell carcinoma | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Unknown primary cancer | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Nervous system disorders | ||||
| Anoxic encephalopathy | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Bleeding intracranial | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Brain stem hemorrhage | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Cerebellar hemorrhage | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Cerebral hematoma | 2/1465 (0.1%) | 2 | 1/1457 (0.1%) | 1 |
| Cerebral hemorrhage | 1/1465 (0.1%) | 1 | 1/1457 (0.1%) | 1 |
| Cerebrovascular accident | 7/1465 (0.5%) | 9 | 10/1457 (0.7%) | 10 |
| Embolic stroke | 2/1465 (0.1%) | 3 | 0/1457 (0%) | 0 |
| Hemorrhagic stroke | 1/1465 (0.1%) | 1 | 1/1457 (0.1%) | 1 |
| Hemorrhagic transformation stroke | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Hypoxic brain damage | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Intracerebral hemorrhage | 1/1465 (0.1%) | 1 | 1/1457 (0.1%) | 1 |
| Intracranial hematoma | 1/1465 (0.1%) | 1 | 1/1457 (0.1%) | 1 |
| Intracranial hemorrhage | 3/1465 (0.2%) | 3 | 1/1457 (0.1%) | 1 |
| Lacunar infarction | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Middle cerebral artery stroke | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Middle cerebral artery thrombosis | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Ruptured cerebral aneurysm | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Subarachnoid hemorrhage | 1/1465 (0.1%) | 1 | 2/1457 (0.1%) | 3 |
| Transient ischaemic attack | 9/1465 (0.6%) | 9 | 9/1457 (0.6%) | 10 |
| Transient ischemic attacks | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Psychiatric disorders | ||||
| Suicide | 1/1465 (0.1%) | 1 | 1/1457 (0.1%) | 1 |
| Renal and urinary disorders | ||||
| Blood clot in urine | 1/1465 (0.1%) | 2 | 0/1457 (0%) | 0 |
| Chronic renal failure | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Hematuria | 1/1465 (0.1%) | 1 | 5/1457 (0.3%) | 5 |
| Renal artery aneurysm | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Renal failure | 2/1465 (0.1%) | 2 | 0/1457 (0%) | 0 |
| Reproductive system and breast disorders | ||||
| Pelvic hematoma | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Acute respiratory failure | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| ARDS | 1/1465 (0.1%) | 1 | 1/1457 (0.1%) | 1 |
| Aspiration pneumonia | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| COPD | 5/1465 (0.3%) | 5 | 5/1457 (0.3%) | 5 |
| COPD exacerbation | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Epistaxis | 5/1465 (0.3%) | 5 | 3/1457 (0.2%) | 3 |
| Hemopneumothorax | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Hemoptysis | 3/1465 (0.2%) | 3 | 1/1457 (0.1%) | 1 |
| Hemothorax | 3/1465 (0.2%) | 3 | 1/1457 (0.1%) | 1 |
| Lung mass | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Mediastinal hematoma | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Pleural effusion | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Pulmonary embolism | 1/1465 (0.1%) | 1 | 1/1457 (0.1%) | 1 |
| Pulmonary fibrosis | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Pulmonary hypertension | 1/1465 (0.1%) | 1 | 1/1457 (0.1%) | 1 |
| Respiratory arrest | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Respiratory failure | 2/1465 (0.1%) | 2 | 5/1457 (0.3%) | 5 |
| Unspecified disease of respiratory system | 0/1465 (0%) | 0 | 2/1457 (0.1%) | 2 |
| Surgical and medical procedures | ||||
| Coronary artery bypass | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Pneumonectomy | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Polypectomy | 0/1465 (0%) | 0 | 2/1457 (0.1%) | 2 |
| Vascular disorders | ||||
| Abdominal aortic aneurysm | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Aortic aneurysm rupture | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Aortic dissection | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Arterial embolism limb | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Arterial hemorrhage | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Arteriosclerotic cardiovascular disease | 3/1465 (0.2%) | 3 | 0/1457 (0%) | 0 |
| Atherosclerotic cardiovascular disease | 2/1465 (0.1%) | 2 | 3/1457 (0.2%) | 3 |
| Bleeding | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Cardiovascular collapse | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Deep vein thrombosis | 1/1465 (0.1%) | 2 | 1/1457 (0.1%) | 1 |
| Dissecting aortic aneurysm | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Embolus | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Femoral artery occlusion | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Hematoma | 6/1465 (0.4%) | 6 | 4/1457 (0.3%) | 4 |
| Hemorrhagic shock | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Thromboembolism | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Vascular pseudoaneurysm | 1/1465 (0.1%) | 1 | 1/1457 (0.1%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Patient Self-Testing (PST) | High Quality Anticoagulation Management (HQACM) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 399/1465 (27.2%) | 332/1457 (22.8%) | ||
| Blood and lymphatic system disorders | ||||
| Anemia | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Cardiac disorders | ||||
| Intracardiac thrombus | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Myocardial infarction | 4/1465 (0.3%) | 4 | 1/1457 (0.1%) | 1 |
| Non-Q wave MI | 19/1465 (1.3%) | 19 | 18/1457 (1.2%) | 18 |
| Q wave MI | 2/1465 (0.1%) | 2 | 3/1457 (0.2%) | 3 |
| Congenital, familial and genetic disorders | ||||
| Arteriovenous malformation | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Gastrointestinal arteriovenous malformation | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Ear and labyrinth disorders | ||||
| Bleeding from ears | 4/1465 (0.3%) | 4 | 7/1457 (0.5%) | 7 |
| Eye disorders | ||||
| Conjunctival bleeding | 4/1465 (0.3%) | 4 | 3/1457 (0.2%) | 3 |
| Corneal bleeding | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Eye hemorrhage | 1/1465 (0.1%) | 1 | 1/1457 (0.1%) | 1 |
| Intraocular hemorrhage | 7/1465 (0.5%) | 7 | 2/1457 (0.1%) | 2 |
| Ocular retrobulbar hemorrhage | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Retinal vein occlusion | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Scleral hemorrhage | 2/1465 (0.1%) | 2 | 2/1457 (0.1%) | 2 |
| Subconjunctival hemorrhage | 10/1465 (0.7%) | 11 | 2/1457 (0.1%) | 2 |
| Vitreous hemorrhage | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Gastrointestinal disorders | ||||
| Bleeding from tongue | 1/1465 (0.1%) | 1 | 2/1457 (0.1%) | 2 |
| Bleeding gastric ulcer | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Bleeding lips | 0/1465 (0%) | 0 | 4/1457 (0.3%) | 4 |
| Bleeding mouth | 5/1465 (0.3%) | 5 | 3/1457 (0.2%) | 3 |
| Blood in stool | 5/1465 (0.3%) | 5 | 5/1457 (0.3%) | 5 |
| Diverticulosis | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Gastritis | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| GI bleed | 27/1465 (1.8%) | 28 | 18/1457 (1.2%) | 19 |
| Gingival bleeding | 3/1465 (0.2%) | 3 | 7/1457 (0.5%) | 7 |
| Hematemesis | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Hematochezia | 0/1465 (0%) | 0 | 3/1457 (0.2%) | 3 |
| Hemoperitoneum | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Hemorrhoidal bleeding | 10/1465 (0.7%) | 13 | 9/1457 (0.6%) | 10 |
| Lower gastrointestinal hemorrhage | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Mallory Weiss tear | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Melena | 2/1465 (0.1%) | 2 | 2/1457 (0.1%) | 2 |
| Perforation post colonoscopy | 2/1465 (0.1%) | 2 | 0/1457 (0%) | 0 |
| Rectal bleeding | 32/1465 (2.2%) | 39 | 35/1457 (2.4%) | 40 |
| Retroperitoneal bleed | 8/1465 (0.5%) | 10 | 4/1457 (0.3%) | 4 |
| UGI bleed | 4/1465 (0.3%) | 4 | 5/1457 (0.3%) | 6 |
| General disorders | ||||
| Catheter site bleeding | 1/1465 (0.1%) | 1 | 2/1457 (0.1%) | 2 |
| Catheter site hematoma | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Central line complication | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Injection site bleeding | 0/1465 (0%) | 0 | 2/1457 (0.1%) | 2 |
| Hepatobiliary disorders | ||||
| Gallbladder hemorrhage | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Infections and infestations | ||||
| Cellulitis of finger | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Cellulitis of leg | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Pneumonia | 2/1465 (0.1%) | 2 | 0/1457 (0%) | 0 |
| Urinary tract infection | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Abrasions | 2/1465 (0.1%) | 2 | 1/1457 (0.1%) | 1 |
| Anemia postoperative | 0/1465 (0%) | 0 | 2/1457 (0.1%) | 2 |
| Arteriovenous graft site hemorrhage | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 4 |
| Bruising | 7/1465 (0.5%) | 8 | 4/1457 (0.3%) | 5 |
| Dog bite | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Femoral artery injury | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Foot injury | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Incision site bleeding | 8/1465 (0.5%) | 8 | 3/1457 (0.2%) | 3 |
| Incision site hematoma | 2/1465 (0.1%) | 2 | 2/1457 (0.1%) | 2 |
| Intraoperative bleeding | 8/1465 (0.5%) | 9 | 12/1457 (0.8%) | 12 |
| Laceration | 19/1465 (1.3%) | 20 | 12/1457 (0.8%) | 12 |
| Limb injury | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Post biopsy bleeding | 4/1465 (0.3%) | 4 | 3/1457 (0.2%) | 3 |
| Post procedural bleeding | 13/1465 (0.9%) | 13 | 7/1457 (0.5%) | 9 |
| Postoperative bleeding | 9/1465 (0.6%) | 9 | 15/1457 (1%) | 15 |
| Postoperative hematoma | 5/1465 (0.3%) | 5 | 2/1457 (0.1%) | 2 |
| Scrotal hematoma | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Tendon rupture | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Traumatic hematoma | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Venous injury | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Wound dehiscence | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Investigations | ||||
| Cystoscopy | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Fecal occult blood | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Hemarthrosis | 2/1465 (0.1%) | 2 | 0/1457 (0%) | 0 |
| Hematoma muscle | 2/1465 (0.1%) | 2 | 1/1457 (0.1%) | 1 |
| Joint bleeding | 3/1465 (0.2%) | 3 | 0/1457 (0%) | 0 |
| Joint hematoma | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Muscle hemorrhage | 0/1465 (0%) | 0 | 2/1457 (0.1%) | 2 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Myelodysplasia | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Nervous system disorders | ||||
| Cerebral infarction | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Haemorrhagic transformation stroke | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Hemorrhagic stroke | 1/1465 (0.1%) | 1 | 2/1457 (0.1%) | 2 |
| Hemorrhagic transformation stroke | 1/1465 (0.1%) | 1 | 1/1457 (0.1%) | 1 |
| Intracranial hemorrhage | 1/1465 (0.1%) | 1 | 1/1457 (0.1%) | 1 |
| Stroke | 24/1465 (1.6%) | 29 | 34/1457 (2.3%) | 41 |
| Renal and urinary disorders | ||||
| Bleeding urogenital | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Hematuria | 67/1465 (4.6%) | 89 | 54/1457 (3.7%) | 72 |
| Renal artery embolism | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Urethral hemorrhage | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Urinary tract bleeding | 8/1465 (0.5%) | 11 | 9/1457 (0.6%) | 9 |
| Reproductive system and breast disorders | ||||
| Bleeding genital | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Hematospermia | 6/1465 (0.4%) | 7 | 1/1457 (0.1%) | 1 |
| Scrotal hemorrhage | 2/1465 (0.1%) | 2 | 1/1457 (0.1%) | 1 |
| Testicular hemorrhage | 1/1465 (0.1%) | 2 | 0/1457 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Effusion pleural bloody | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Epistaxis | 79/1465 (5.4%) | 130 | 63/1457 (4.3%) | 88 |
| Hemoptysis | 11/1465 (0.8%) | 13 | 17/1457 (1.2%) | 19 |
| Hemorrhage from throat | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Hemothorax | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Pleural hemorrhage | 1/1465 (0.1%) | 1 | 1/1457 (0.1%) | 1 |
| Pulmonary embolism | 3/1465 (0.2%) | 3 | 5/1457 (0.3%) | 5 |
| Respiratory tract hemorrhage | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Skin and subcutaneous tissue disorders | ||||
| Ecchymosis | 12/1465 (0.8%) | 21 | 0/1457 (0%) | 0 |
| Foot ulcer | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Hemorrhage subcutaneous | 3/1465 (0.2%) | 3 | 0/1457 (0%) | 0 |
| Surgical and medical procedures | ||||
| Circumcision | 0/1465 (0%) | 0 | 2/1457 (0.1%) | 2 |
| Ileostomy | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Vascular disorders | ||||
| Bleeding | 32/1465 (2.2%) | 45 | 27/1457 (1.9%) | 31 |
| Bleeding varicose vein | 1/1465 (0.1%) | 1 | 0/1457 (0%) | 0 |
| Deep venous thrombosis arm | 2/1465 (0.1%) | 2 | 2/1457 (0.1%) | 2 |
| Deep venous thrombosis femoral | 1/1465 (0.1%) | 1 | 1/1457 (0.1%) | 1 |
| DVT | 2/1465 (0.1%) | 2 | 8/1457 (0.5%) | 8 |
| Embolus arm | 0/1465 (0%) | 0 | 1/1457 (0.1%) | 1 |
| Hematoma | 25/1465 (1.7%) | 25 | 14/1457 (1%) | 14 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Bob Edson |
|---|---|
| Organization | Palo Alto CSPCC |
| Phone | (650) 493-5000 ext 22250 |
| Bob.Edson@va.gov |
Responsible Party:
US Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00032591
Other Study ID Numbers:
- 481
First Posted:
Mar 28, 2002
Last Update Posted:
Apr 15, 2014
Last Verified:
Mar 1, 2014