Trial · NCT02234843
EINSTEIN Junior: Oral Rivaroxaban in Children With Venous Thrombosis
NCT02234843, Phase 3, Completed, Bayer; results first posted 2020-04-01
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. EINSTEIN Junior: Oral Rivaroxaban in Children With Venous Thrombosis. Trials, record NCT02234843. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02234843
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- EINSTEIN Junior: Oral Rivaroxaban in Children With Venous Thrombosis
- NCT number
- NCT02234843
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 500 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Venous Thromboembolism
- Interventions
- Rivaroxaban (Xarelto, BAY59-7939), Rivaroxaban (Xarelto, BAY59-7939), Standard of Care
- First posted
- 2014-09-09
- Last updated
- 2020-04-01
- Other registries' IDs
- eudract:2014-000565-47
- Results first posted
- 2020-04-01
Source ClinicalTrials.gov
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period | During the main study treatment period (i.e., 3 months, except for children with central venous catheter venous thromboembolism (CVC-VTE) aged <2 years for whom it was 1 month) | The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference population |
| Primary | Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period | During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month) | The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference population |
| Primary | Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During Extended Treatment Period | During extended treatment period: up to month 12. | Incidence rates for all children except those aged \< 2 years with catheter-related thrombosis. If no participant in the specific subgroup entered in the specific optional extension period, no analysis of an outcome was possible., The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference Population. |
| Primary | Number of Subjects With the Composite of All Symptomatic Recurrent Venous Thromboembolism During the 30 Days Post-study Treatment Period (i.e. >2 and ≤ 30 Days After Stop of Study Medication) | More than 2 and up to 30 days after stop of study medication | The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Age group with primary efficacy outcome was reported. |
| Primary | Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Main Treatment Period | During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month) | The Central independent adjudication committee (CIAC) classified bleeding as: Major bleeding defined as overt bleeding and: · associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Clinically relevant non-major bleeding defined as overt bleeding not meeting the criteria for major bleeding, but associated with: medical intervention, or unscheduled contact (visit or telephone call) with a physician, or (temporary) cessation of study treatment, or discomfort for the child such as pain or impairment of activities of daily life (such as loss of school days or hospitalization). |
| Primary | Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Extended Treatment Period | During extended treatment period: up to month 12. | Incidence rates for all children except those aged \< 2 years with catheter-related thrombosis. If no participant entered in the specific optional extension period, no analysis of an outcome was possible. The CIAC classified bleeding as: Major bleeding defined as overt bleeding and: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Clinically relevant non-major bleeding defined as overt bleeding not meeting the criteria for major bleeding, but associated with: medical intervention, or unscheduled contact with a physician, or (temporary) cessation of study treatment, or discomfort for the child such as pain or impairment of activities of daily life. |
| Secondary | Incidence Rates of the Composite of All Symptomatic Recurrent Venous Thromboembolism and Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging During the Main Treatment Period | During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month) | The secondary efficacy outcome defined as the composite of all symptomatic recurrent venous thromboembolism and asymptomatic deterioration on repeat imaging as assessed by central independent adjudication committee. (CIAC) Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference population |
| Secondary | AUC(0-24)ss in Plasma | over 24 hours | AUC(0-24)ss: Area under the concentration vs. time curve from time 0 to 24 hours at steady state. |
| Secondary | Cmax,ss in Plasma | 0 hours to 24 hours, 0 hours to 12 hours or 0 hours to 8 hours (one dosing interval in steady state) | Maximum drug concentration in measured matrix at steady state during a dosage interval |
| Secondary | Ctrough,ss in Plasma | 0 hours to 24 hours, 0 hours to 12 hours or 0 hours to 8 hours(one sampling interval in steady state) | Ctrough,ss refers to the drug concentration at the end of the dosage interval at steady state |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 registered outcomesOutcomes35
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period | During the main study treatment period (i.e., 3 months, except for children with central venous catheter venous thromboembolism (CVC-VTE) aged <2 years for whom it was 1 month) | Full analysis set (FAS) | Percentage of participants | NUMBER |
| PRIMARY | Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period | During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month) | Full analysis set (FAS) | Percentage of participants | NUMBER |
| PRIMARY | Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During Extended Treatment Period | During extended treatment period: up to month 12. | Full analysis set (FAS) | Percentage of participants | NUMBER |
| PRIMARY | Number of Subjects With the Composite of All Symptomatic Recurrent Venous Thromboembolism During the 30 Days Post-study Treatment Period (i.e. >2 and ≤ 30 Days After Stop of Study Medication) | More than 2 and up to 30 days after stop of study medication | Full analysis set (FAS) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Main Treatment Period | During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month) | Safety analysis set (SAF) | Percentage of participants | NUMBER |
| PRIMARY | Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Main Treatment Period | During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month) | Safety analysis set (SAF) | Percentage of participants | NUMBER |
| PRIMARY | Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Extended Treatment Period | During extended treatment period: up to month 12. | Safety analysis set (SAF) | Percentage of participants | NUMBER |
| SECONDARY | Incidence Rates of the Composite of All Symptomatic Recurrent Venous Thromboembolism and Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging During the Main Treatment Period | During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month) | Full analysis set (FAS) | Percentage of participants | NUMBER |
| SECONDARY | AUC(0-24)ss in Plasma | over 24 hours | Pharmacokinetics analysis set (PKS) | microgram*hour per liter | GEOMETRIC_MEAN |
| SECONDARY | Cmax,ss in Plasma | 0 hours to 24 hours, 0 hours to 12 hours or 0 hours to 8 hours (one dosing interval in steady state) | Pharmacokinetics analysis set (PKS) | microgram per liter | GEOMETRIC_MEAN |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 outcomesResults by group170
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period | Rivaroxaban Group | 1.2 | 95% Confidence Interval 0.4 to 3.0 | Percentage of participants | |
| Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period | Comparator Group | 3.0 | 95% Confidence Interval 1.2 to 6.6 | Percentage of participants | |
| Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period | Rivaroxaban, Aged 12-<18 | 2.2 | 95% Confidence Interval 0.7 | Percentage of participants | |
| Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period | Rivaroxaban, Aged 6-<12 | 0.0 | 95% Confidence Interval 0.0 | Percentage of participants | |
| Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period | Rivaroxaban, Aged 2-<6 | 0.0 | 95% Confidence Interval 0.0 | Percentage of participants | |
| Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period | Rivaroxaban, Aged 0.5-<2 | 0.0 | 95% Confidence Interval 0.0 | Percentage of participants | |
| Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period | Rivaroxaban, Aged Birth-<0.5 | 0.0 | 95% Confidence Interval 0.0 | Percentage of participants | |
| Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period | Comparator, Aged 12-<18 | 3.3 | 95% Confidence Interval 0.9 | Percentage of participants | |
| Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period | Comparator, Aged 6-<12 | 2.9 | 95% Confidence Interval 0.2 | Percentage of participants | |
| Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period | Comparator, Aged 2-<6 | 4.5 | 95% Confidence Interval 0.2 | Percentage of participants |
1 to 10 of 170Source ClinicalTrials.gov
See all 170 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rivaroxaban, Aged 12-<18 | 184 | |
| Overall Study | STARTED | Rivaroxaban, Aged 6-<12 | 67 | |
| Overall Study | STARTED | Rivaroxaban, Aged 2-<6 | 47 | |
| Overall Study | STARTED | Rivaroxaban, Aged 0.5-<2 | 21 | |
| Overall Study | STARTED | Rivaroxaban, Aged Birth-<0.5 | 16 | |
| Overall Study | STARTED | Comparator, Aged 12-<18 | 92 | |
| Overall Study | STARTED | Comparator, Aged 6-<12 | 34 | |
| Overall Study | STARTED | Comparator, Aged 2-<6 | 22 | |
| Overall Study | STARTED | Comparator, Aged 0.5-<2 | 9 | |
| Overall Study | STARTED | Comparator, Aged Birth-<0.5 | 8 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events1,340
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Comparator Group | 5 | 162 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | Rivaroxaban Group | 11 | 329 | 20 |
| other | Coagulopathy | Blood and lymphatic system disorders | Comparator Group | 0 | 162 | 0 |
| other | Coagulopathy | Blood and lymphatic system disorders | Rivaroxaban Group | 2 | 329 | 2 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Comparator Group | 0 | 162 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Rivaroxaban Group | 3 | 329 | 3 |
| other | Haemolysis | Blood and lymphatic system disorders | Comparator Group | 0 | 162 | 0 |
| other | Haemolysis | Blood and lymphatic system disorders | Rivaroxaban Group | 1 | 329 | 1 |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Comparator Group | 3 | 162 | 3 |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Rivaroxaban Group | 1 | 329 | 1 |
1 to 10 of 1,340Source ClinicalTrials.gov
See all 1,340 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Comparator Group | 0 | 162 |
| Total, all-cause mortality | Rivaroxaban Group | 2 | 329 |
| Total, other adverse events | Comparator Group | 121 | 162 |
| Total, other adverse events | Rivaroxaban Group | 275 | 329 |
| Total, serious adverse events | Comparator Group | 35 | 162 |
| Total, serious adverse events | Rivaroxaban Group | 78 | 329 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Comparator Group vs Rivaroxaban Group: deaths from any cause | Trial comparisons |
| Comparator Group vs Rivaroxaban Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02234843
GET https://conductscience.org/api/trials/v1/NCT02234843/registered?page=2