This page shows what was measured, who it was measured in, and what that does not settle.
What Edoxaban does in the body
Stroke prevention in an irregular heartbeat, and treatment of clots in the legs and lungs
Your blood makes clots through a relay of enzymes, and factor Xa is the one near the end that mass-produces thrombin, the enzyme that actually builds the clot. Edoxaban plugs the active site of factor Xa directly, without needing the helper protein antithrombin that heparin depends on. Less factor Xa activity means far less thrombin, and less thrombin means the fibrin mesh of a clot is never assembled. About half the drug leaves through the kidneys, which is why kidney function changes how much of it is in your blood.
What happened in people
Stroke or systemic embolism 1.18% per year on high-dose edoxaban against 1.50% on warfarin during treatment, HR 0.79 (97.5% CI 0.63 to 0.99), in 21,105 randomised patients
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.
The only direct oral anticoagulant whose United States label restricts use in patients with better kidney function
Where it acts
Blood plasma, at the prothrombinase complex assembled on the surface of activated platelets
Kind of result
Living longer, or avoiding a major event
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · NDU3J18APO · read 2026-08-29
Its recorded molecular formula is C24H30ClN7O4S∙C7H8O3S, weighing 738.27.
US prescribing information · e77d3400-56ad-11e3-949a-0800200c9a66 · read 2026-08-30
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 141 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
Randomisation
Randomisation means chance decides who gets which treatment.
A picture of it, and where the picture fails
It is like a coin toss deciding the groups.
Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.
What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.
Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.
Absolute difference
An absolute difference is how many more people in a hundred were affected.
A picture of it, and where the picture fails
It is like counting heads in two rooms of a hundred.
Where that stops being true. Heads are easy to count. Study results carry a margin of error too.
What people get wrong. It is confused with a percentage change, which can look far larger.
The arithmetic difference in event rates between arms.
Confidence interval
A confidence interval is the range the true answer is likely to sit in.
A picture of it, and where the picture fails
It is like a weather forecast giving a range rather than one number.
Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.
What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.
An interval estimate that would contain the true parameter in a stated proportion of repeated studies.
What happened in people◇Read from sources, not yet reviewed
What was measured, goal by goal
One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.
Registered studies list 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.
There is no single score. A strong test result and a weak life result are different facts.
Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Pain
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
…Waiting for a reviewer1 registered symptom measure.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Pain
affected leg pain
Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.
What each mark on this table means
∅ Nothing in the sources checked
No registered study lists a life outcome for this goal.
… Waiting for a reviewer
1 registered symptom measure.
— Not recorded
Harms were not a registered measure for this goal.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Stroke or systemic embolism, two once-daily edoxaban regimens versus adjusted-dose warfarin
✓ The study showed what it set out to show
Who was studied
ENGAGE AF-TIMI 48 (NCT00781391)
How many people
21105
Study design
Phase 3 randomised double-blind double-dummy trial, median follow-up 2.8 years
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
On treatment: high dose 1.18% vs 1.50% per year, HR 0.79 (97.5% CI 0.63 to 0.99), p<0.001 for non-inferiority; low dose 1.61% per year, HR 1.07 (0.87 to 1.31), p=0.005 for non-inferiority. Intention to treat, high dose: HR 0.87 (97.5% CI 0.73 to 1.04), p=0.08
Repeated elsewhere
Unreplicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Superiority was not demonstrated on intention to treat. An exploratory renal subgroup gave a hazard ratio of 1.36 (0.88 to 2.10) for stroke or systemic embolism above a creatinine clearance of 95 mL/min, interaction p=0.08, and became a boxed warning.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral film-coated tablet, once daily
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Recurrent symptomatic venous thromboembolism, edoxaban versus warfarin after initial heparin
✓ The study showed what it set out to show
Who was studied
Hokusai-VTE (NCT00986154)
How many people
8292
Study design
Phase 3 randomised double-blind non-inferiority trial, 3 to 12 months of treatment
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
3.2% vs 3.5%, HR 0.89 (95% CI 0.70 to 1.13), p<0.001 for non-inferiority. Major or clinically relevant non-major bleeding 8.5% vs 10.3%, HR 0.81 (0.71 to 0.94), p=0.004 for superiority
Repeated elsewhere
Partially Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. All patients received at least five days of parenteral heparin before randomised oral treatment began, so the trial does not describe edoxaban used alone from the outset.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral film-coated tablet, once daily
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
Composite of recurrent venous thromboembolism or major bleeding at 12 months, edoxaban versus dalteparin
✓ The study showed what it set out to show
Who was studied
Hokusai VTE Cancer (NCT02073682)
How many people
1046
Study design
Phase 3 randomised open-label non-inferiority trial, up to 12 months
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
12.8% vs 13.5%, HR 0.97 (95% CI 0.70 to 1.36), p=0.006 for non-inferiority, p=0.87 for superiority
Repeated elsewhere
Partially Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. The composite concealed opposing components: recurrent venous thromboembolism 7.9% vs 11.3%, but major bleeding 6.9% vs 4.0% (risk difference 2.9 points, 95% CI 0.1 to 5.6), concentrated in upper gastrointestinal bleeding in gastrointestinal cancers. Open-label design.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral film-coated tablet, once daily
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
Composite of death, myocardial infarction, ischaemic stroke, systemic thromboembolism, valve thrombosis or major bleeding after transcatheter aortic valve replacement
Efficacy composite 17.3 vs 16.5 per 100 person-years, HR 1.05 (95% CI 0.85 to 1.31), p=0.01 for non-inferiority. Major bleeding 9.7 vs 7.0 per 100 person-years, HR 1.40 (1.03 to 1.91), p=0.93 for non-inferiority — the safety endpoint failed its non-inferiority test
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. The bleeding excess was mainly gastrointestinal. Mean age was 82.1 years. The hierarchical testing plan meant no superiority claim could be made once the bleeding test failed.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral film-coated tablet, once daily
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
2.3% vs 6.7% per year, HR 0.34 (95% CI 0.19 to 0.61), p<0.001. Major bleeding 3.3% vs 1.8%, HR 1.87 (0.90 to 3.89), p=0.09
Repeated elsewhere
Unreplicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Substantially more gastrointestinal bleeding on edoxaban. The comparator was placebo, not an active anticoagulant, and the 15 mg strength tested is not approved in the United States. 303 of 984 patients discontinued.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral film-coated tablet, once daily
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
RNAWiki holds 5 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What happened in people◇Read from sources, not yet reviewed
How close this is to real life
The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.
■Living longer, or avoiding a major eventEvidence recorded. Death, a heart attack, a stroke, a hospital stay.10 registered measures of this kind. 1 written-up study measured this and did not show a benefit.
□What a body can do day to dayNo evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
□Measured performanceNo evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
■Symptoms and quality of lifeEvidence recorded. Pain, tiredness, mood, sleep, as the person rated it.2 registered measures of this kind.
□A number that stands in for healthNo evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.No registered study measures this.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.2 registered measures inside human tissue.
□AnimalsNo evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
□Cells in a dishNo evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it changes in the body◇Read from sources, not yet reviewed
The path through the body
From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.
Start
Edoxaban
What a person takes: Oral film-coated tablet, once daily.
The measurement behind this step
Edoxaban tosylate monohydrate tablets, taken once a day with or without food. Absorption does not depend on meals, which distinguishes it from rivaroxaban at treatment doses. For venous thromboembolism the label requires 5 to 10 days of a parenteral anticoagulant first: every patient in Hokusai-VTE received heparin before the tablet, and the trial says nothing about starting with the tablet alone.
Getting in
A tablet absorbed the same way whether or not you have eaten
Swallowed once a day. Unlike some drugs in its class it does not need to be taken with food, and most of it is absorbed within an hour or two.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
Edoxaban tosylate monohydrate, oral bioavailability approximately 62%, peak plasma concentration in 1 to 2 hours. Absorption occurs mainly in the proximal small intestine and is not meaningfully food-dependent. Very little of the drug is metabolised by cytochrome P450 3A4, so its interactions are transporter interactions rather than metabolic ones.
A pump in the gut wall decides how much gets through
A protein in the intestinal lining pushes some of the drug back out before it reaches the blood. Drugs that block that pump raise edoxaban levels.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Edoxaban is a P-glycoprotein substrate. Potent P-glycoprotein inhibitors — verapamil, quinidine, dronedarone, ketoconazole, erythromycin — raise exposure, and rifampicin lowers it. This transporter, not a metabolising enzyme, is the site of essentially every clinically listed edoxaban interaction.
It sits in the pocket factor Xa uses to grip its target
Factor Xa recognises what to cut using two adjacent pockets. The drug is shaped so that one end fills each of them, and nothing else can dock.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
The 5-chloropyridyl oxamide occupies the S1 specificity pocket and the tetrahydrothiazolopyridine occupies the aromatic S4 pocket, with the cyclohexane core holding the two in an L-shaped conformation. Binding is direct, selective, reversible and competitive, requires no antithrombin cofactor, and inhibits factor Xa both free in plasma and already assembled into prothrombinase.
The thrombin amplifier is turned down, not switched off
One molecule of factor Xa makes about a thousand molecules of thrombin. Blocking it upstream means far less thrombin is made, rather than none at all.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Inhibiting prothrombinase suppresses the burst conversion of prothrombin to thrombin. Downstream consequences follow from the shortage of thrombin rather than from any direct action: less fibrinogen cleaved to fibrin, less factor XIII activation to cross-link the mesh, less thrombin-mediated platelet activation through PAR-1, and less feedback amplification through factors V, VIII and XI.
Half of it leaves through the kidneys, and the label is built on that
About half the absorbed drug is filtered out by the kidneys unchanged. Kidneys that work poorly leave too much in the blood; kidneys that work very well are the basis of the warning on the box.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Approximately 50% of absorbed edoxaban is renally cleared as unchanged drug, with a half-life of 10 to 14 hours. Both ends of the United States label follow from this single number: dose reduction at low creatinine clearance, and a boxed warning of reduced efficacy above 95 mL/min. In ENGAGE AF the measured result was stroke or systemic embolism 1.18% per year against 1.50% on warfarin during treatment, and major bleeding 2.75% against 3.43%.
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 5 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
What it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
affected leg pain
quality of life anticoagulant treatment
Measured
Things only a test, a scale or a device shows.
asymptomatic cerebral event on mri 24 hours
asymptomatic cerebral event on mri 30 days
Meaningful
Things that change how a life goes, not only a number.
new stroke
death
ischemic stroke
hemorrhagic stroke
stroke
stroke or systemic embolism
recurrent stroke of any type
incidence of non hemorrhagic stroke or systemic embolism
time to the first incident ischemic stroke event
death anticoagulant treatment
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
anti fxa activity from baseline to the end of infusion nadir
primary endpoint
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What it would be like to take◇Read from sources, not yet reviewed
How long anything takes
Nine different lengths of time that get confused with each other. None of them is worked out from another.
Before anything is noticed.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before a test result moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before performance moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
How long the result was watched.No finished study window is recorded for a study that tested this substance.
How long people took it.How long people actually took it is not stored. The study window is not the same thing.
How long people were followed.Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.
How fast the body clears it. 10 to 14 hours hours
Read from the label, which states: “The terminal elimination half-life of edoxaban following oral administration is 10 to 14 hours.”
How long effects linger.RNAWiki does not store this separately, and never works it out from another figure on this page.
Beyond the studies. Nothing is recorded about the long term.
The longest finished study sets the edge of what anyone measured.
A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Adults with atrial fibrillation not caused by a diseased or replaced heart valve, and adults who have had a deep vein thrombosis or pulmonary embolism and have already completed several days of injected anticoagulation. It is the least prescribed of the four direct oral anticoagulants in the United States.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “The safety and effectiveness of SAVAYSA have not been established in pediatric patients with confirmed VTE (PE and/or DVT).”
US prescribing information · e77d3400-56ad-11e3-949a-0800200c9a66 · read 2026-08-30
On older people, the label states: “Of the total patients in the ENGAGE AF-TIMI 48 study, 5182 (74%) were 65 years and older, while 2838 (41%) were 75 years and older.”
US prescribing information · e77d3400-56ad-11e3-949a-0800200c9a66 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Available data about SAVAYSA use in pregnant women are insufficient to determine whether there are drug-associated risks for adverse developmental outcomes.”
US prescribing information · e77d3400-56ad-11e3-949a-0800200c9a66 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of edoxaban in human milk, or its effects on the breastfeeding infant or on milk production.”
US prescribing information · e77d3400-56ad-11e3-949a-0800200c9a66 · read 2026-08-30
On people with reduced liver function, the label states: “The use of SAVAYSA in patients with moderate or severe hepatic impairment (Child-Pugh B and C) is not recommended as these patients may have intrinsic coagulation abnormalities.”
US prescribing information · e77d3400-56ad-11e3-949a-0800200c9a66 · read 2026-08-30
On people with reduced kidney function, the label states: “Renal clearance accounts for approximately 50% of the total clearance of edoxaban.”
US prescribing information · e77d3400-56ad-11e3-949a-0800200c9a66 · read 2026-08-30
Where the result stopped carrying
Superiority for stroke prevention in ENGAGE AF-TIMI 48 on the intention-to-treat analysis, p=0.08
The low-dose edoxaban regimen, which was non-inferior on treatment but trended unfavourably on intention to treat (HR 1.13) and was never approved for atrial fibrillation in the United States
The major bleeding non-inferiority test in ENVISAGE-TAVI AF, HR 1.40 (1.03 to 1.91), which also blocked any superiority claim under the trial’s testing hierarchy
Major bleeding against dalteparin in cancer-associated thrombosis, 6.9% against 4.0%
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied for a different goal
The studies measured something else entirely.
On this record: Some registered studies measured things that match no goal on this page.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral film-coated tablet, once daily
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
RNAWiki has not recorded a supervision or regulatory status for this substance.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
No register row and no identity class settled the question.
No source is stored against this line.
What is in the pack
Edoxaban tosylate monohydrate tablets, taken once a day with or without food. Absorption does not depend on meals, which distinguishes it from rivaroxaban at treatment doses.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold. The rest of the recorded wording: For venous thromboembolism the label requires 5 to 10 days of a parenteral anticoagulant first: every patient in Hokusai-VTE received heparin before the tablet, and the trial says nothing about starting with the tablet alone.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take◇Read from sources, not yet reviewed
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
·Worth asking a clinician aboutWritten into the record from the studies named on this page
The United States label carries a three-part boxed warning: reduced efficacy in nonvalvular atrial fibrillation with creatinine clearance above 95 mL/min, increased risk of ischaemic events on premature discontinuation, and spinal or epidural haematoma with neuraxial anaesthesia or spinal puncture. Roughly half the absorbed drug is renally cleared, so reduced kidney function raises exposure and bleeding risk. Gastrointestinal bleeding is the dominant bleeding pattern in the elderly, post-TAVR and cancer populations. There is no reversal agent approved for edoxaban in the United States.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
These are reports people sent to a regulator. They do not show the medicine caused the reaction.
Nobody counted how many people took the medicine and reported nothing.
The same event can be reported more than once, and many reports are incomplete.
News coverage, lawsuits and new warnings change how often people report.
A count is not a rate and not a risk.
Edoxaban appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 649 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
anaemia — 135 reaction mentions
general physical health deterioration — 94 reaction mentions
open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Oral film-coated tablet, once daily
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Absorption does not depend on meals, which distinguishes it from rivaroxaban at treatment doses.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on which forms are sold. The rest of the recorded wording: For venous thromboembolism the label requires 5 to 10 days of a parenteral anticoagulant first: every patient in Hokusai-VTE received heparin before the tablet, and the trial says nothing about starting with the tablet alone.
No source is stored against this line.
What is recorded as being sold
18 products list this as an active ingredient in the United States drug directory. 18 of them contain it and nothing else.
FDA National Drug Code directory · 42765-063 · read 2026-08-29
They are sold as powder and tablet, film coated, taken oral.
FDA National Drug Code directory · 42765-063 · read 2026-08-29
The regulator's established pharmacologic class for it is factor xa inhibitor [epc] and factor xa inhibitors [moa].
FDA National Drug Code directory · 42765-063 · read 2026-08-29
1 published label names it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · e77d3400-56ad-11e3-949a-0800200c9a66 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · e77d3400-56ad-11e3-949a-0800200c9a66 · read 2026-08-29
SAVAYSA is oral at 3 DOSAGE FORMS AND STRENGTHS 60 mg, yellow round shaped, film-coated tablets, debossed with DSC L60 on one side 30 mg, pink round shaped, film-coated tablets, debossed with DSC L30 on one side 15 mg, orange round shaped…, recorded as fda label in effect 2025-07-10 in the United States.
US prescribing information · e77d3400-56ad-11e3-949a-0800200c9a66 · read 2026-08-30
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.
Questions worth asking
Which of the trials of Edoxaban studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
Claims that go past the evidence
Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.
✗Goes past the evidence
That edoxaban prevents more strokes than warfarin — the intention-to-treat hazard ratio was 0.87 with p=0.08, and the published conclusion claims non-inferiority only
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That edoxaban is measurably less effective above a creatinine clearance of 95 mL/min — the boxed warning rests on an exploratory subgroup with a hazard ratio of 1.36 (95% CI 0.88 to 2.10) and an interaction p of 0.08
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That a tied composite in cancer-associated thrombosis means the two treatments are equivalent — the recurrence advantage and the bleeding excess cancelled each other inside the composite
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That the factor Xa antidote covers edoxaban — andexanet alfa is labelled for rivaroxaban and apixaban only, on a laboratory surrogate, with haemostatic improvement not established
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That the ELDERCARE-AF result applies outside its trial — a placebo comparator and a 15 mg strength not approved in the United States
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Edoxaban are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
Every line above can be traced to the study named beside it. Follow the link and read it.
ENGAGE AF-TIMI 48: non-inferior to a well-managed warfarin arm, at both doses
In plain words
In 21,105 people with atrial fibrillation followed for a median of 2.8 years, edoxaban prevented strokes and travelling clots about as well as warfarin did. The warfarin arm in this trial was unusually well controlled, which made it a hard target.
What was measured
Annualised rate of stroke or systemic embolism during treatment, over a median of 2.8 years
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
ENGAGE AF-TIMI 48 (NCT00781391) was a randomised, double-blind, double-dummy trial of two once-daily edoxaban regimens against adjusted-dose warfarin in 21,105 patients with moderate-to-high-risk atrial fibrillation, median follow-up 2.8 years. During treatment the annualised rate of stroke or systemic embolism was 1.50% on warfarin, whose median time in the therapeutic range was 68.4%, against 1.18% on high-dose edoxaban (hazard ratio 0.79, 97.5% CI 0.63 to 0.99, p<0.001 for non-inferiority) and 1.61% on low-dose edoxaban (hazard ratio 1.07, 97.5% CI 0.87 to 1.31, p=0.005 for non-inferiority). The key secondary composite of stroke, systemic embolism or cardiovascular death was 4.43% per year on warfarin against 3.85% on high-dose edoxaban (hazard ratio 0.87, 95% CI 0.78 to 0.96, p=0.005).
Written into the record, not signed off as a reviewed claim
Major bleeding fell from 3.43% to 2.75% a year, and cardiovascular death with it
In plain words
The clearest benefit in the trial was not fewer strokes but less bleeding. At the higher dose about one bleed in five was avoided, and at the lower dose more than half were.
What was measured
Annualised major bleeding rate and cardiovascular death rate, and the consistency of the bleeding effect across renal function
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Annualised major bleeding in ENGAGE AF was 3.43% on warfarin against 2.75% on high-dose edoxaban (hazard ratio 0.80, 95% CI 0.71 to 0.91, p<0.001) and 1.61% on low-dose edoxaban (hazard ratio 0.47, 95% CI 0.41 to 0.55, p<0.001). Death from cardiovascular causes was 3.17% per year on warfarin against 2.74% on high dose (hazard ratio 0.86, 95% CI 0.77 to 0.97, p=0.01) and 2.71% on low dose (hazard ratio 0.85, 95% CI 0.76 to 0.96, p=0.008). The bleeding reduction is the finding that survives every analysis of this trial, including the renal subgroup analysis where the efficacy signal does not: bleeding was lower at every level of creatinine clearance, interaction p=0.11.
Written into the record, not signed off as a reviewed claim
Superiority over warfarin was never demonstrated once everyone randomised was counted
In plain words
The headline number comes from counting only the time people were actually taking the drug. Count everyone who was randomised, which is the stricter and more honest analysis, and the advantage over warfarin disappears into chance.
What was measured
That edoxaban prevents more strokes than warfarin — the on-treatment hazard ratio of 0.79 is a non-inferiority result, and the intention-to-treat hazard ratio of 0.87 did not reach significance at p=0.08
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The 1.18% against 1.50% comparison is the on-treatment analysis, which is the correct primary analysis for a non-inferiority question and the wrong one for a superiority claim. In the prespecified intention-to-treat analysis of ENGAGE AF, high-dose edoxaban gave a hazard ratio of 0.87 (97.5% CI 0.73 to 1.04, p=0.08) — a trend, not a result — and low-dose edoxaban an unfavourable 1.13 (97.5% CI 0.96 to 1.34, p=0.10). The published conclusion says so plainly: both regimens were "noninferior to warfarin". Edoxaban is a drug that ties on clots and wins on bleeding, and any description of it as more effective than warfarin at preventing stroke is reading the wrong column.
Written into the record, not signed off as a reviewed claim
The boxed warning excluding the best kidneys rests on a subgroup whose interval crosses one
In plain words
This drug carries a boxed warning telling doctors not to use it in people whose kidneys work well. The number behind that warning came from a subgroup analysis that was not statistically significant, and the authors of that analysis concluded the drug’s overall benefit held across all kidney function.
What was measured
Hazard ratio for stroke or systemic embolism, higher-dose edoxaban versus warfarin, in the exploratory creatinine clearance >95 mL/min stratum: 1.36 (95% CI 0.88 to 2.10), interaction p=0.08
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The United States label opens with a boxed warning of reduced efficacy in nonvalvular atrial fibrillation patients with creatinine clearance above 95 mL/min, and section 1.1 carries the same statement as a Limitation of Use. The underlying analysis is Bohula et al., which examined 14,071 patients across the range of creatinine clearance. The prespecified cut point of 50 mL/min showed no interaction at all: hazard ratio 0.87 above and 0.87 below, interaction p=0.94. The signal appears only in exploratory cut points — creatinine clearance above 95 mL/min gave a hazard ratio of 1.36 with a 95% confidence interval of 0.88 to 2.10 and an interaction p of 0.08. That interval includes 1.00 and that p value does not cross any conventional threshold. The paper’s own conclusion states that the safety and net clinical benefit of the higher-dose regimen "are consistent across the range of renal function". The mechanism proposed — that better renal clearance means lower drug exposure and thinner protection — is biologically reasonable and is not the same thing as a measured effect. This is the clearest inference-versus-measurement gap on the page, and it went into a black box on the label.
Written into the record, not signed off as a reviewed claim
ENVISAGE-TAVI AF: the bleeding half of the trial failed its non-inferiority test
In plain words
In 1,426 people with atrial fibrillation who had just had a heart valve replaced through a catheter, edoxaban matched warfarin overall but caused significantly more serious bleeding, most of it in the gut.
What was measured
Major bleeding rate per 100 person-years after transcatheter aortic valve replacement
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
ENVISAGE-TAVI AF (NCT02943785) randomised 1,426 patients with atrial fibrillation after successful transcatheter aortic valve replacement, mean age 82.1 years, to edoxaban or a vitamin K antagonist under a hierarchical testing plan. The composite primary efficacy outcome occurred at 17.3 per 100 person-years on edoxaban against 16.5 on the vitamin K antagonist (hazard ratio 1.05, 95% CI 0.85 to 1.31, p=0.01 for non-inferiority against a 1.38 margin). The primary safety outcome went the other way: major bleeding 9.7 per 100 person-years against 7.0 (hazard ratio 1.40, 95% CI 1.03 to 1.91, p=0.93 for non-inferiority) — a failed non-inferiority test with a confidence interval entirely above 1.00, driven mainly by gastrointestinal bleeding. Because the hierarchy required superiority for bleeding before efficacy superiority could be tested, no superiority claim was possible. The result inverts the finding that ENGAGE AF is usually summarised by, and it does so in the oldest population studied.
Written into the record, not signed off as a reviewed claim
Hokusai-VTE: equal on recurrent clots, better on bleeding, in 8,292 patients
In plain words
For clots in the legs and lungs, edoxaban prevented recurrence as well as warfarin and caused less bleeding. The advantage was largest in the sickest group, those whose pulmonary embolism had strained the right side of the heart.
What was measured
Recurrent symptomatic venous thromboembolism, and major or clinically relevant non-major bleeding, over 3 to 12 months
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Hokusai-VTE (NCT00986154) randomised 8,292 patients with acute venous thromboembolism — 4,921 with deep vein thrombosis and 3,319 with pulmonary embolism — to edoxaban or warfarin after initial heparin, for 3 to 12 months. Recurrent symptomatic venous thromboembolism occurred in 130 edoxaban patients (3.2%) and 146 warfarin patients (3.5%), hazard ratio 0.89 (95% CI 0.70 to 1.13, p<0.001 for non-inferiority), against a warfarin arm with 63.5% time in the therapeutic range. Major or clinically relevant non-major bleeding occurred in 349 (8.5%) against 423 (10.3%), hazard ratio 0.81 (95% CI 0.71 to 0.94, p=0.004 for superiority). In the 938 patients with pulmonary embolism and right ventricular dysfunction by N-terminal pro-brain natriuretic peptide, recurrence was 3.3% against 6.2%, hazard ratio 0.52 (95% CI 0.28 to 0.98). That last figure is a subgroup and should be read as one.
Written into the record, not signed off as a reviewed claim
Hokusai VTE Cancer moved the field off injected heparin — and bought it with bleeding
In plain words
For twenty years, people with cancer who developed a clot were given daily injections. This trial showed a tablet worked, and it also showed the tablet caused more serious bleeding. Both halves are in the same result.
What was measured
Recurrent venous thromboembolism and major bleeding, separately, over 12 months in cancer patients
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Hokusai VTE Cancer (NCT02073682) randomised 1,046 analysable patients with cancer-associated venous thromboembolism to edoxaban after at least five days of low molecular weight heparin, or to subcutaneous dalteparin for up to 12 months. The composite primary outcome of recurrent venous thromboembolism or major bleeding occurred in 67 of 522 edoxaban patients (12.8%) against 71 of 524 dalteparin patients (13.5%), hazard ratio 0.97 (95% CI 0.70 to 1.36, p=0.006 for non-inferiority, p=0.87 for superiority). The components moved in opposite directions and the composite hid it: recurrent venous thromboembolism 7.9% against 11.3% (risk difference -3.4 percentage points, 95% CI -7.0 to 0.2) and major bleeding 6.9% against 4.0% (risk difference 2.9 percentage points, 95% CI 0.1 to 5.6, an interval that excludes zero). The excess was concentrated in upper gastrointestinal bleeding in patients with gastrointestinal cancers. The field’s conclusion shifted from "low molecular weight heparin only" to "a direct oral anticoagulant is acceptable, and the choice depends on where the tumour is" — a change driven by a trial whose composite endpoint was a tie.
Written into the record, not signed off as a reviewed claim
There is no reversal agent approved for edoxaban in the United States
In plain words
Two of the four direct oral anticoagulants have a specific antidote. Edoxaban is not one of them: the factor Xa antidote is approved only for rivaroxaban and apixaban.
What was measured
That the factor Xa antidote covers the factor Xa inhibitors as a class — it is labelled for two of them, on a surrogate endpoint, and edoxaban is not among them
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Andexanet alfa is the recombinant decoy factor Xa developed to reverse factor Xa inhibitors. Its United States label indicates it "for patients treated with rivaroxaban or apixaban", and does not name edoxaban. That indication is itself an accelerated approval based on the change from baseline in anti-factor Xa activity in healthy volunteers, and the label states in as many words that "an improvement in hemostasis has not been established". So the reversal situation for this class has two separate gaps: edoxaban has no approved agent at all, and the agent that exists for its two nearest relatives was approved on a laboratory surrogate rather than on a bleeding outcome. Idarucizumab, by contrast, reverses only dabigatran, which is not a factor Xa inhibitor.
Source
ANDEXXA (coagulation factor Xa (recombinant), inactivated-zhzo) United States prescribing information, section 1
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
ELDERCARE-AF: a 15 mg dose beat placebo in the very old, at a bleeding cost
In plain words
In 984 Japanese patients aged 80 and over who were considered unsuitable for normal anticoagulant doses, a very low dose cut strokes by about two thirds. Serious bleeding rose, mostly in the gut, though not by a statistically clear margin.
What was measured
Annualised stroke or systemic embolism, major bleeding and all-cause death against placebo in patients aged 80 and over
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
ELDERCARE-AF (NCT02801669) randomised 984 Japanese patients aged 80 or older with nonvalvular atrial fibrillation, judged inappropriate for approved anticoagulant doses, to edoxaban 15 mg once daily or placebo. The annualised rate of stroke or systemic embolism was 2.3% against 6.7% (hazard ratio 0.34, 95% CI 0.19 to 0.61, p<0.001). Major bleeding was 3.3% against 1.8% (hazard ratio 1.87, 95% CI 0.90 to 3.89, p=0.09), with substantially more gastrointestinal bleeding on edoxaban. All-cause death was 9.9% against 10.2% (hazard ratio 0.97, 95% CI 0.69 to 1.36) — no mortality difference. Two limits belong on any reading of this trial: the comparator was placebo rather than another anticoagulant, and the 15 mg strength it tested is not an approved dose in the United States.
This order is fixed in code and does not count clicks or time on the page.
What is not here
3 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
The older medicine-wide conclusion held in this record
Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.
A once-daily factor Xa blocker that matched warfarin rather than beating it on stroke prevention in 21,105 patients — 1.18% against 1.50% a year on treatment, but a non-significant 0.87 hazard ratio once everyone randomised was counted — while cutting major bleeding from 3.43% to 2.75% a year, and which carries a boxed warning against use in people with the best kidney function.
Recorded evidence blocks (14)
Q1
What did Edoxaban's largest trial (1000000 people) and its longest (12 years) measure?
1000000 people in Edoxaban's largest registered study, 12 years in its longest registered window, measuring Percentage of Participants With Composite Endpoint of Stroke, Systemic Embolic Stroke (SEE), Myocardial Infarction (MI) and Cardiovascular (CV) Mortality From Randomization to End of Follow up. ClinicalTrials.gov · 2026-09-01
33 phase3, 30 na or unstated, 20 phase4, 18 phase2, 9 na, 7 phase1; NCT03642509; 2030-10-01. Last human test completed 2026, NCT03950076.
Interpretation These counts include studies where Edoxaban was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.
Show the evidence
phase3
33
na or unstated
30
phase4
20
phase2
18
na
9
phase1
7
1 more recorded row
Last recorded human testNCT03950076
2026-07-22
recorded 2026-09-01 · last checked 2026-09-04
Q2
Edoxaban was tested only in human — what did it show?
Interpretation Percentage of Participants With Composite Endpoint of Stroke, Systemic Embolic Stroke (SEE), Myocardial Infarction (MI) and Cardiovascular (CV) Mortality From… — the recorded outcome words.
Show the evidence
humanNCT02072434
lifespan; Percentage of Participants With Composite Endpoint of Stroke, Systemic Embolic Stroke (SEE), Myocardial Infarction (MI) and Cardiovascular (CV) Mortality From Randomization to End of Follow up; 113
recorded 2026-09-01 · last checked 2026-09-04
Q3
5 of Edoxaban's trials stopped: safety, futility/efficacy, accrual/recruitment?
16 recorded entries; human; also "Edoxaban tablets (low dose regimen-30mg)", "DU-176b 15mg", "DU-176b 30mg"
Show the evidence
human
NCT00781391
Edoxaban tablets (high dose regimen-60mg)
NCT00781391
Edoxaban tablets (low dose regimen-30mg)
NCT01203098
DU-176b 15mg
NCT01203098
DU-176b 30mg
NCT01857583
15mg DU-176b
NCT01857583
30mg DU-176b
10 more recorded rows
humanNCT01857622
DU-176b 60mg
humanNCT02047565
60mg edoxaban
humanNCT02047565
180mg edoxaban
humanNCT02567461
Edoxaban 60 mg
humanNCT02567461
Edoxaban 30 mg
humanNCT03083704
Edoxaban 60 MG
humanNCT05723510
Edoxaban 60mg
humanNCT05723510
Lixiana Tab. 60mg
humanNCT06372483
Edoxaban 60 mg Oral Tablet
humanNCT07454707
Edoxaban 15 mg
recorded 2026-09-01 · last checked 2026-09-04
Q5
Edoxaban's half-life is 10 to 14 hours — which schedules were studied?
10 to 14 hours, the half-life Edoxaban's label states. openfda-label · e77d3400-56ad-11e3-949a-0800200c9a66 · 2026-08-30
bioavailability 62% %.
Show the evidence
half life
10 to 14 hours hours; The terminal elimination half-life of edoxaban following oral administration is 10 to 14 hours.
bioavailability
62% %; Absolute bioavailability is 62%.
metabolism
Metabolism Unchanged edoxaban is the predominant form in plasma.
recorded 2026-08-30 · last checked 2026-09-04
Q6
Could one person measure Edoxaban's effect on adjudicated incidence of bleeding events?
Adjudicated incidence of bleeding events: measured in Edoxaban's trials.
Interpretation adjudicated incidence of bleeding events is the recorded endpoint.
Show the evidence
biomarkers
adjudicated incidence of bleeding events; 2026-09-01
liver related laboratory marked abnormalities; 2026-09-01
incidence of all bleeding; 2026-09-01
incidence of venous thromboembolism events; 2026-09-01
venous thromboembolism events; 2026-09-01
incidence of adverse events; 2026-09-01
14 more recorded rows
biomarkers
incidence of adverse drug reactions; 2026-09-01
biomarkers
pts assessment completion; 2026-09-01
biomarkers
new stroke; 2026-09-01
biomarkers
major bleeding; 2026-09-01
biomarkers
death; 2026-09-01
biomarkers
transient ischemic attack; 2026-09-01
biomarkers
ischemic stroke; 2026-09-01
biomarkers
hemorrhagic stroke; 2026-09-01
biomarkers
heavy bleeding; 2026-09-01
biomarkers
stroke; 2026-09-01
biomarkers
asymptomatic cerebral event on mri 24 hours; 2026-09-01
biomarkers
asymptomatic cerebral event on mri 30 days; 2026-09-01
biomarkers
cumulative non fatal vte recurrence at 6 months; 2026-09-01
biomarkers
efficacy on coagulation parameters; 2026-09-01
half life
2026-09-04; halfLife; hours; 10 to 14 hours; 2026-08-30
human trials at or under30
10
smallest human trial
0; NCT04002011; PHASE2; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN
Q7
Which of adjudicated incidence of bleeding events, affected leg pain and anti fxa activity from baseline to the end of infusion nadir did Edoxaban's trials measure?
adjudicated incidence of bleeding events, affected leg pain and anti fxa activity from baseline to the end of infusion nadir lead 40 outcome terms across Edoxaban's trials. ClinicalTrials.gov · 2026-09-01
Interpretation incidence of venous thromboembolism events, venous thromboembolism events, incidence of adverse events, incidence of adverse drug reactions, pts assessment completion and new stroke follow.
Show the evidence
adjudicated incidence of bleeding events
1
liver related laboratory marked abnormalities
1
incidence of all bleeding
1
incidence of venous thromboembolism events
1
venous thromboembolism events
1
incidence of adverse events
1
14 more recorded rows
incidence of adverse drug reactions
1
pts assessment completion
1
new stroke
1
major bleeding
1
death
1
transient ischemic attack
1
ischemic stroke
1
hemorrhagic stroke
1
heavy bleeding
1
stroke
1
asymptomatic cerebral event on mri 24 hours
1
asymptomatic cerebral event on mri 30 days
1
cumulative non fatal vte recurrence at 6 months
1
efficacy on coagulation parameters
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Edoxaban's 16 ongoing trials reports first?
Primary efficacy outcome: A composite endpoint of stroke, myocardial infarction, thromboembolic event or all-cause death.; Primary efficacy outcome: a composite endpoint of new venous thromboembolism or all-cause death.; latest 2031-12-31
Show the evidence
Trial
NCT03129490
"The Danish Non-vitamin K Antagonist Oral Anticoagulation Study in Patients With Atrial Fibrillation"; n 11000; "Primary efficacy outcome: A composite endpoint of stroke, myocardial infarction, thromboembolic event or all-cause death."; 2027-10-30
NCT03129555
"The Danish Non-vitamin K Antagonist Oral Anticoagulation Study in Patients With Venous Thromboembolism (DANNOAC-VTE)"; n 5000; "Primary efficacy outcome: a composite endpoint of new venous thromboembolism or all-cause death."; 2029-03-31
NCT03642509
"Left Atrial Appendage Occlusion Versus Novel Oral Anticoagulation for Stroke Prevention in Atrial Fibrillation"; n 750; "Composite endpoint of stroke (ischemic and hemorrhagic), systemic embolism, major bleeding and all-cause mortality."; 2030-10-01
NCT03968393
"Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Atrial Fibrillation Occurring Transiently With Stress"; n 2270; "Incidence of Non-hemorrhagic stroke or systemic embolism"; 2028-12
NCT04262492
"International Registry of Thrombotic APS Patients Treated With Direct Oral Anticoagulants"; n 500; "Rate of Recurrent Thrombosis"; 2031-04-21
NCT04284839
"The Direct Oral Anticoagulation Versus Vitamin K Antagonist After Cardiac Surgery Trial"; n 3500; "Major Bleeding"; 2027-06
10 further recorded trials
NCT06149533
"Evaluate the Efficacy and Safety of Edoxaban on Prevention of Catheter-related Thrombosis (CRT) in Cancer Patients"; n 366; "The incidence of catheter-related thrombosis during catheter"; 2026-11-30
NCT06322953
"Timing to Restart Direct Oral Anticoagulants After Traumatic Intracranial Haemorrhage"; n 1084; "Proportion of patients with haemorrhagic or thrombotic event within 12 weeks following tICrH."; 2028-07-31
NCT06372483
"Single Dose Trial of VMX-C001 in Healthy Subjects with and Without FXa Direct Oral Anticoagulant"; n 40; "Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Part 1)"; 2026-08
NCT06402851
"Vitamin K AntagonISt, Factor Xa Inhibitor or No Anticoagulation in Atrial Fibrillation and DIalytic End-stage Renal DiseasE (VISIONAIRE)"; n 1500; "Primary efficacy endpoint"; 2026-12
NCT06449469
"The Nordic Aortic Valve Intervention Trial 4 (NOTION-4)"; n 352; "HALT after 1 year"; 2030-04-01
NCT06650501
"Dabigatran vs. Oral Anti-Xa Inhibitors in S. Aureus Bacteremia"; n 300; "Desirability of Outcome Ranking (DOOR)"; 2030-01
NCT06900725
"Low Dose Edoxaban in Elderly Patients With AF and a History of Stroke"; n 300; "The proportion of patients achieving edoxaban concentrations within the expected range"; 2030-12-31
NCT07116239
"Edoxaban Steady-State PK/PD in Adults With Nephrotic Syndrome"; n 60; "area under the steady-state plasma concentration-time curve (AUCss)"; 2026-02
NCT07454707
"Testing a New Treatment Strategy to Improve Secondary Stroke Prevention for Older Adults: The STROKE75+ Trial"; n 1204; "Rate of new strokes (fatal or non-fatal)"; 2031-12
NCT07753200
"Net Clinical Benefit of Edoxaban Versus Apixaban in Patients With Atrial Fibrillation and Coronary Artery Disease"; n 3000; "Net Adverse Clinical Events (NACE)"; 2031-12-31
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which running trial of Edoxaban could settle lifespan?
NCT03642509 measures Composite endpoint of stroke (ischemic and hemorrhagic), systemic embolism, major bleeding and all-cause mortality., reading out 2030-10-01.
1 open trial; n 750; "Left Atrial Appendage Occlusion Versus Novel Oral Anticoagulation for Stroke Prevention in Atrial Fibrillation"
Show the evidence
TrialNCT03642509
"Left Atrial Appendage Occlusion Versus Novel Oral Anticoagulation for Stroke Prevention in Atrial Fibrillation"; n 750; "Composite endpoint of stroke (ischemic and hemorrhagic), systemic embolism, major bleeding and all-cause mortality."; 2030-10-01
Q10
Which 37 trials of Edoxaban posted no result?
Posted no result
37 of 37 completed trials
Registrations
NCT02047565, NCT03296982, NCT02207257, NCT02607371, NCT03083704 and NCT02567461, and 31 more
Completion dates
oldest 2014-05; newest 2024-08-01
Show the evidence
Trial
NCT02047565
2014-05
NCT03296982
2015-02
NCT02207257
2015-11
NCT02607371
2016-10-15
NCT03083704
2017-09-28
NCT02567461
2018-03-15
14 further recorded trials
NCT02950168
2018-07-26
NCT02964949
2018-10-09
NCT03666650
2019-01-08
NCT02935855
2019-09
NCT03244319
2019-09-30
NCT02952599
2019-10-29
NCT03563937
2019-12-10
NCT03433235
2020-07-02
NCT04121767
2020-07-10
NCT02951039
2020-10-15
NCT04192916
2020-12-31
NCT03153150
2021-03-26
NCT03489395
2021-04-30
NCT05262322
2021-07-09
Q11
At the median, Edoxaban's trials enrolled 300 people — anything larger?
Median enrolment
300
Largest enrolment
1000000
Registered trials counted
113
Q12
What do 649 spontaneous reports say about Edoxaban — and not say?
These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.
Edoxaban appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 649 reaction mentions were counted: anaemia 135; general physical health deterioration 94; haematochezia 76; dizziness 64. open-targets-adr · CHEMBL1269025 · 2026-06-24
Show the evidence
anaemia
135
general physical health deterioration
94
haematochezia
76
dizziness
64
fall
56
pallor
53
4 more recorded rows
haematuria
47
gastrointestinal haemorrhage
45
abdominal pain
41
cerebral infarction
38
recorded 2026-06-24 · last checked 2026-09-04
Q13
Edoxaban and P-GP, CYP3A4 and CYP1A2: shared by which compounds?
P-GP, CYP3A4 and CYP1A2 appear in Edoxaban's recorded interaction sentences, 3 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP1A2pharmacokinetics
Drug Interactions In vitro Drug Interactions Studies In vitro studies indicate that edoxaban does not inhibit the major cytochrome P450 enzymes (CYP1A2, 2A6, 2B6, 2C8/9, 2C19, 2D6, 2E1, or 3A4) and does not induce CYP1A2, CYP3A4 or the P-gp transporter (MDR1).
CYP3A4
pharmacokinetics
There is minimal metabolism via hydrolysis (mediated by carboxylesterase 1), conjugation, and oxidation by CYP3A4.
pharmacokinetics
Drug Interactions In vitro Drug Interactions Studies In vitro studies indicate that edoxaban does not inhibit the major cytochrome P450 enzymes (CYP1A2, 2A6, 2B6, 2C8/9, 2C19, 2D6, 2E1, or 3A4) and does not induce CYP1A2, CYP3A4 or the P-gp transporter (MDR1).
recorded 2026-08-30 · last checked 2026-09-04
Q14
Was Edoxaban studied with exercise?
exercise is named in Edoxaban's label sentences: "The intervention was more effective in frail participants than in non-frail counterparts in two studies (e.g., aerobic exercise), less effective in frail participants in three studies (e.g., intensive lifestyle intervention), similarly effective across frailty levels in seven studies (e.g.,…" openfda-label+europepmc · 2026-08-30
1 recorded statement; exercise
Show the evidence
exercise
The intervention was more effective in frail participants than in non-frail counterparts in two studies (e.g., aerobic exercise), less effective in frail participants in three studies (e.g., intensive lifestyle intervention), similarly effective across frailty levels in seven studies (e.g., prasugrel), and inconclusive in six studies (e.g., edoxaban).
recorded 2026-08-30 · last checked 2026-09-04
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