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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-005732-18 | EudraCT Number |
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This is the first evaluation of edoxaban in pediatric subjects. In this Phase 1 study, a single dose of edoxaban will be given to pediatric subjects who require anticoagulant therapy to see what the body does to the drug (pharmacokinetics) and what the drug does to the body (pharmacodynamics), and to compare if these effects are similar to those observed in adults.
Phase 1, open-label, multiple-center study in pediatric patients from 0 to < 18 years of age. Patients will receive a single dose of edoxaban to match either the 30 mg (low dose) or the 60 mg (high dose) exposure in adults. Exact doses will be selected during the study on the basis of PK modeling of emerging data. If unanticipated exposures are observed, the target doses may be modified to best match expected exposure response relationships observed in adults.
Enrollment in the study will start with the low dose, highest age group (adolescents) and will continue from low to high dose in each age group and from higher to lower age groups. Enrollment in the next dose/age cohort will begin after 50% of the subjects have completed the previous dose/age cohort.
Age cohorts and dose groups: (6 participants each in low and high dose groups, for a total of 12 participants per age cohort)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1a | Experimental | 12 to < 18 years of age: edoxaban low dose group |
|
| Cohort 1b | Experimental | 12 to < 18 years of age: edoxaban high dose group |
|
| Cohort 2a | Experimental | 6 to < 12 years of age: edoxaban low dose group |
|
| Cohort 2b | Experimental | 6 to < 12 years of age: edoxaban high dose group |
|
| Cohort 3a | Experimental | 2 to < 6 years of age: edoxaban low dose group |
|
| Cohort 3b | Experimental | 2 to < 6 years of age: edoxaban high dose group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edoxaban low dose | Drug | Edoxaban low dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Parameter of Apparent Systemic Clearance (CL/F) | A model-based pooled population pharmacokinetic (PK) method was used to estimate systemic clearance (CL/F). As prespecified in the protocol, arms were pooled due to sparse PK samples being collected. the median PK estimate is reported in all participants at a total of 5 blood samplings. | 0.25 to 1 hours, 1.5 to 3 hours, 4 to 8 hours, 9 to 14 hours, and 24 to 36 hours post-dose |
| Pharmacokinetic Parameter of Apparent Volume of Distribution (V/F) | A model-based pooled population pharmacokinetic (PK) method was used to estimate apparent volume of distribution (V/F). As prespecified in the protocol, arms were pooled due to sparse PK samples being collected. the median PK estimate is reported in all participants at a total of 5 blood samplings. | 0.25 to 1 hours, 1.5 to 3 hours, 4 to 8 hours, 9 to 14 hours, and 24 to 36 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic Parameter Mean Prothrombin Time (PT) | Descriptive statistics were used to assess Mean Prothrombin Time (PT) by cohort at a total of 6 blood samplings. | Pre-dose and 0.25 to 1 hours (except for Cohorts 4a, 4b, 5a, and 5b, 0.5 to 2 hours), 1.5 to 3 hours, 4 to 8 hours, 9 to 14 hours, and 24 to 36 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Palatability Score for the Liquid Formulation on a 100 mm Visual Analog Scale (VAS) | Overall palatability, bitterness, sweetness, and overall taste or aroma were assessed by participants (or guardians) receiving the liquid oral suspension where each subscale used a 100 mm visual analog scale (VAS), where a 0 score corresponded to a sad face and indicated a low palatability, bitter (sharp, pungent taste or smell), not sweet, and no aroma score (eg, patients not pleased; worse outcome in terms of palatability) and a 100 score corresponded to a happy face and indicated a high palatability, not bitter, very sweet, very tasty, and high aroma score (eg, patients were pleased; best outcome in terms of palatability). Patients who were old enough scored the VAS themselves. For younger children, the parents provided this information, if possible. For the youngest children, there was free text input available to provide information on whether the patient spat it out or may not have liked the flavor, etc. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles (UCLA) | Los Angeles | California | 90095 | United States | ||
| Lucile Packard Children's Hospital Stanford University |
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Participants were asked to fast for at least 4 hours before dosing and for an additional 2 hours after dosing. If this was not feasible because of the participant's age or other needs, (unflavored) milk, or an equivalent substitute liquid (but not fruit juices), was allowed until 1 hour before and starting at 1 hour postdose (total volume of liquids not to exceed 240 mL).
A total of 66 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study and received treatment at 32 clinical sites in the United States, Canada, France, India, Italy, Jordan, Lebanon, Spain, Turkey, and the United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1a: 30 mg Edoxaban | Participants who were 12 to < 18 years of age and received a single-dose, oral tablet of 30 mg edoxaban. |
| FG001 | Cohort 1b: 60 mg Edoxaban | Participants who were 12 to < 18 years of age and received a single dose, oral tablet of 60 mg edoxaban. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 16, 2019 |
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| Cohort 4a | Experimental | 6 months to <2 years of age: edoxaban low dose group |
|
| Cohort 4b | Experimental | 6 months to <2 years of age: edoxaban high dose group |
|
| Cohort 5a | Experimental | 0 to 6 months of age: edoxaban low dose group |
|
| Cohort 5b | Experimental | 0 to 6 months: edoxaban high dose group |
|
| Edoxaban high dose | Drug | Edoxaban high dose |
|
| Pharmacodynamic Parameter Mean Activated Partial Thromboplastin Time (aPTT) |
Descriptive statistics were used to assess Mean Activated Partial Thromboplastin Time by cohort for a total of 6 blood samplings. |
| Pre-dose and 0.25 to 1 hours (except for Cohorts 4a, 4b, 5a, and 5b, 0.5 to 2 hours), 1.5 to 3 hours, 4 to 8 hours, 9 to 14 hours, and 24 to 36 hours post-dose |
| Pharmacodynamic Parameter Mean Anti-Factor Xa (FXa) | Descriptive statistics were used to assess Mean Anti-Factor Xa (FXa) by cohort for a total of 6 blood samplings. | Pre-dose and 0.25 to 1 hours (except for Cohorts 4a, 4b, 5a, and 5b, 0.5 to 2 hours), 1.5 to 3 hours, 4 to 8 hours, 9 to 14 hours, and 24 to 36 hours post-dose |
| Baseline up to 30 minutes post-dose |
| Palo Alto |
| California |
| 94304 |
| United States |
| University of Colorado Denver | Denver | Colorado | 80045 | United States |
| Ann and Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States |
| Indiana Hemophilia and Thrombosis Center | Indianapolis | Indiana | 46260 | United States |
| University of Louisville ; Kosair Charities Pediatric Clincial Research Unit | Louisville | Kentucky | 40202 | United States |
| Duke University Medical Center (DUMC) | Durham | North Carolina | 22710 | United States |
| University Hospitals Case Medical Center - Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106 | United States |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Hasbro Children's Hospital | Providence | Rhode Island | 02903 | United States |
| St. Jude Children's Research Hospital, Inc. | Memphis | Tennessee | 38105 | United States |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| McMaster Children's Hospital | Hamilton | Ontario | L8N3Z5 | Canada |
| Childrens Hospital of Eastern Ontario | Ottawa | K1H8L1 | Canada |
| Hopital Arnaud de Villeneuve | Montpellier | 34295 | France |
| CHU Bordeaux - Hopital Haut-Leveque | Pessac | 33604 | France |
| Nirmal Hospital Pvt. Ltd | Gujrāt | 395002 | India |
| Institute of Child Health | Kolkata | 700017 | India |
| Christian Medical College and Hospital | Ludhiāna | 141008 | India |
| Istituto Giannina Gaslini - UOSD Emostasi e Trombosi | Genova | 16148 | Italy |
| A O Universita degli Studi di Padova ; Dipartimento di Salute della Donna e del Bambino-Universita di Padova | Padova | 35127 | Italy |
| Bambino Gesu Hospital | Rome | 165 | Italy |
| Hotel Dieu De France | Beirut | BP 165191 | Lebanon |
| Hammoud Hospital University Medical Center | Saida | 1600 | Lebanon |
| Hospital Universitario Vall d'Hebron | Barcelona | 8035 | Spain |
| Hospital Universitario Reina Sofia | Córdoba | 14004 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Universitario Araba | Vitoria-Gasteiz | 01010 | Spain |
| Ege University Medical Faculty - Department of Pediatric Hematology | Izmir | 35040 | Turkey (Türkiye) |
| Leeds General Infirmary | Leeds | LS1 3EB | United Kingdom |
| Glenfield Hospital | Leicester | LE3 9QP | United Kingdom |
| Guy's and St Thomas Hospital NHS Trust | London | SE1 7EH | United Kingdom |
| Royal Brompton Hospital | London | SW3 6NP | United Kingdom |
| Southampton General Hospital | Southampton | SO16 6YD | United Kingdom |
| FG002 | Cohort 2a: 24 mg Edoxaban | Participants who were 6 to < 12 years of age and received a single dose, oral suspension of 24 mg edoxaban. |
| FG003 | Cohort 2b: 45 mg Edoxaban | Participants who were 6 to < 12 years of age and received a single dose, oral suspension of 45 mg edoxaban. |
| FG004 | Cohort 3a: 0.7 mg/kg Edoxaban | Participants who were 2 to < 6 years of age and received a single dose, oral suspension of 0.7 mg/kg (cap 24 mg) edoxaban. |
| FG005 | Cohort 3b: 1.4 mg/kg Edoxaban | Participants who were 2 to < 6 years of age and received a single dose, oral suspension of 1.4 mg/kg (cap 45 mg) edoxaban. |
| FG006 | Cohort 4a: 0.75 mg/kg Edoxaban | Participants who were 6 months to <2 years of age and received a single dose, oral suspension of 0.75 mg/kg edoxaban. |
| FG007 | Cohort 4b: 1.5 mg/kg Edoxaban | Participants who were 6 months to <2 years of age and received a single dose, oral suspension of 1.5 mg/kg edoxaban. |
| FG008 | Cohort 5a: 0.4 mg/kg Edoxaban | Participants who were 0 to 6 months of age and received a single dose, oral suspension of 0.4 mg/kg edoxaban. |
| FG009 | Cohort 5b: 0.8 mg/kg Edoxaban | Participants who were 0 to 6 months of age and received a single dose, oral suspension of 0.8 mg/kg edoxaban. |
| COMPLETED |
|
| NOT COMPLETED |
|
Baseline characteristics were assessed in the Safety Analysis Set.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1a: 30 mg Edoxaban | Participants who were 12 to < 18 years of age and received a single-dose, oral tablet of 30 mg edoxaban. |
| BG001 | Cohort 1b: 60 mg Edoxaban | Participants who were 12 to < 18 years of age and received a single dose, oral tablet of 60 mg edoxaban. |
| BG002 | Cohort 2a: 24 mg Edoxaban | Participants who were 6 to < 12 years of age and received a single dose, oral suspension of 24 mg edoxaban. |
| BG003 | Cohort 2b: 45 mg Edoxaban | Participants who were 6 to < 12 years of age and received a single dose, oral suspension of 45 mg edoxaban. |
| BG004 | Cohort 3a: 0.7 mg/kg Edoxaban | Participants who were 2 to < 6 years of age and received a single dose, oral suspension of 0.7 mg/kg (cap 24 mg) edoxaban. |
| BG005 | Cohort 3b: 1.4 mg/kg Edoxaban | Participants who were 2 to < 6 years of age and received a single dose, oral suspension of 1.4 mg/kg (cap 45 mg) edoxaban. |
| BG006 | Cohort 4a: 0.75 mg/kg Edoxaban | Participants who were 6 months to <2 years of age and received a single dose, oral suspension of 0.75 mg/kg edoxaban. |
| BG007 | Cohort 4b: 1.5 mg/kg Edoxaban | Participants who were 6 months to <2 years of age and received a single dose, oral suspension of 1.5 mg/kg edoxaban. |
| BG008 | Cohort 5a: 0.4 mg/kg Edoxaban | Participants who were 0 to 6 months of age and received a single dose, oral suspension of 0.4 mg/kg edoxaban. |
| BG009 | Cohort 5b: 0.8 mg/kg Edoxaban | Participants who were 0 to 6 months of age and received a single dose, oral suspension of 0.8 mg/kg edoxaban. |
| BG010 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacokinetic Parameter of Apparent Systemic Clearance (CL/F) | A model-based pooled population pharmacokinetic (PK) method was used to estimate systemic clearance (CL/F). As prespecified in the protocol, arms were pooled due to sparse PK samples being collected. the median PK estimate is reported in all participants at a total of 5 blood samplings. | Pharmacokinetic parameters were assessed in the Population Pharmacokinetic (PopPK) Analysis Set. As prespecified in the study protocol, PK parameters were reported from the pooled PopPK dataset in order to support dose determination in the ongoing Phase 3 DU176b-A-U312. The current pooled PopPK dataset included participants who were newborn to <18 years of age (Cohort 1 to 5) as reported in the table. | Posted | Median | 90% Confidence Interval | L/h | 0.25 to 1 hours, 1.5 to 3 hours, 4 to 8 hours, 9 to 14 hours, and 24 to 36 hours post-dose |
|
|
| |||||||||||||||||||||||||
| Primary | Pharmacokinetic Parameter of Apparent Volume of Distribution (V/F) | A model-based pooled population pharmacokinetic (PK) method was used to estimate apparent volume of distribution (V/F). As prespecified in the protocol, arms were pooled due to sparse PK samples being collected. the median PK estimate is reported in all participants at a total of 5 blood samplings. | Pharmacokinetic parameters were assessed in the Population Pharmacokinetic (PopPK) Analysis Set. As prespecified in the study protocol, PK parameters were reported from the pooled PopPK dataset in order to support dose determination in the ongoing Phase 3 DU176b-A-U312. The current pooled PopPK dataset included participants who were newborn to <18 years of age (Cohort 1 to 5) as reported in the table. | Posted | Median | 90% Confidence Interval | Liters | 0.25 to 1 hours, 1.5 to 3 hours, 4 to 8 hours, 9 to 14 hours, and 24 to 36 hours post-dose |
|
| ||||||||||||||||||||||||||
| Secondary | Pharmacodynamic Parameter Mean Prothrombin Time (PT) | Descriptive statistics were used to assess Mean Prothrombin Time (PT) by cohort at a total of 6 blood samplings. | Pharmacodynamic (PD) parameters were assessed in participants with available data in the Pharmacodynamic Analysis Set. PD data were not assessed at certain timepoints due to patients not being available for the analysis (ie, indicated by rows with 0 participants at certain timepoints). In addition, standard deviation was not calculated for rows with just 1 participant in the analysis; data are reported for the timepoints in which data were collected. | Posted | Mean | Standard Deviation | seconds | Pre-dose and 0.25 to 1 hours (except for Cohorts 4a, 4b, 5a, and 5b, 0.5 to 2 hours), 1.5 to 3 hours, 4 to 8 hours, 9 to 14 hours, and 24 to 36 hours post-dose |
| |||||||||||||||||||||||||||
| Secondary | Pharmacodynamic Parameter Mean Activated Partial Thromboplastin Time (aPTT) | Descriptive statistics were used to assess Mean Activated Partial Thromboplastin Time by cohort for a total of 6 blood samplings. | Pharmacodynamic (PD) parameters were assessed in participants with available data in the Pharmacodynamic Analysis Set. PD data were not assessed at certain timepoints due to patients not being available for the analysis (ie, indicated by rows with 0 participants at certain timepoints). In addition, standard deviation was not calculated for rows with just 1 participant in the analysis; data are reported for the timepoints in which data were collected. | Posted | Mean | Standard Deviation | seconds | Pre-dose and 0.25 to 1 hours (except for Cohorts 4a, 4b, 5a, and 5b, 0.5 to 2 hours), 1.5 to 3 hours, 4 to 8 hours, 9 to 14 hours, and 24 to 36 hours post-dose |
| |||||||||||||||||||||||||||
| Secondary | Pharmacodynamic Parameter Mean Anti-Factor Xa (FXa) | Descriptive statistics were used to assess Mean Anti-Factor Xa (FXa) by cohort for a total of 6 blood samplings. | Pharmacodynamic (PD) parameters were assessed in participants with available data in the Pharmacodynamic Analysis Set. PD data were not assessed at certain timepoints due to patients not being available for the analysis (ie, indicated by rows with 0 participants at certain timepoints). In addition, standard deviation was not calculated for rows with just 1 participant in the analysis; data are reported for the timepoints in which data were collected. | Posted | Mean | Standard Deviation | IU/mL | Pre-dose and 0.25 to 1 hours (except for Cohorts 4a, 4b, 5a, and 5b, 0.5 to 2 hours), 1.5 to 3 hours, 4 to 8 hours, 9 to 14 hours, and 24 to 36 hours post-dose |
| |||||||||||||||||||||||||||
| Other Pre-specified | Mean Palatability Score for the Liquid Formulation on a 100 mm Visual Analog Scale (VAS) | Overall palatability, bitterness, sweetness, and overall taste or aroma were assessed by participants (or guardians) receiving the liquid oral suspension where each subscale used a 100 mm visual analog scale (VAS), where a 0 score corresponded to a sad face and indicated a low palatability, bitter (sharp, pungent taste or smell), not sweet, and no aroma score (eg, patients not pleased; worse outcome in terms of palatability) and a 100 score corresponded to a happy face and indicated a high palatability, not bitter, very sweet, very tasty, and high aroma score (eg, patients were pleased; best outcome in terms of palatability). Patients who were old enough scored the VAS themselves. For younger children, the parents provided this information, if possible. For the youngest children, there was free text input available to provide information on whether the patient spat it out or may not have liked the flavor, etc. | Palatability scores were assessed in patients who received an oral suspension of edoxaban. | Posted | Mean | Standard Deviation | mm | Baseline up to 30 minutes post-dose |
|
Treatment-emergent adverse events (TEAEs) were collected after the participant (or parent/guardian) signed the informed consent form and through the follow-up visit, up to 10 days after the single dose of exodaban.
A TEAE is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsening relative to the pretreatment state.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1a: 30 mg Edoxaban | Participants who were 12 to < 18 years of age and received a single-dose, oral tablet of 30 mg edoxaban. | 0 | 8 | 0 | 8 | 2 | 8 |
| EG001 | Cohort 1b: 60 mg Edoxaban | Participants who were 12 to < 18 years of age and received a single dose, oral tablet of 60 mg edoxaban. | 0 | 7 | 0 | 7 | 2 | 7 |
| EG002 | Cohort 2a: 24 mg Edoxaban | Participants who were 6 to < 12 years of age and received a single dose, oral suspension of 24 mg edoxaban. | 0 | 7 | 0 | 7 | 4 | 7 |
| EG003 | Cohort 2b: 45 mg Edoxaban | Participants who were 6 to < 12 years of age and received a single dose, oral suspension of 45 mg edoxaban. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG004 | Cohort 3a: 0.7 mg/kg Edoxaban | Participants who were 2 to < 6 years of age and received a single dose, oral suspension of 0.7 mg/kg (cap 24 mg) edoxaban. | 0 | 7 | 0 | 7 | 1 | 7 |
| EG005 | Cohort 3b: 1.4 mg/kg Edoxaban | Participants who were 2 to < 6 years of age and received a single dose, oral suspension of 1.4 mg/kg (cap 45 mg) edoxaban. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG006 | Cohort 4a: 0.75 mg/kg Edoxaban | Participants who were 6 months to <2 years of age and received a single dose, oral suspension of 0.75 mg/kg edoxaban. | 0 | 7 | 0 | 7 | 3 | 7 |
| EG007 | Cohort 4b: 1.5 mg/kg Edoxaban | Participants who were 6 months to <2 years of age and received a single dose, oral suspension of 1.5 mg/kg edoxaban. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG008 | Cohort 5a: 0.4 mg/kg Edoxaban | Participants who were 0 to 6 months of age and received a single dose, oral suspension of 0.4 mg/kg edoxaban. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG009 | Cohort 5b: 0.8 mg/kg Edoxaban | Participants who were 0 to 6 months of age and received a single dose, oral suspension of 0.8 mg/kg edoxaban. | 0 | 6 | 0 | 6 | 0 | 6 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Frequent bowel movements | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Prothrombin time prolonged | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Psychomotor hyperactivity | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Sickle cell anaemia with crisis | Congenital, familial and genetic disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Contact for Clinical Trial Information | Daiichi Sankyo, Inc. | 908-992-6400 | CTRinfo@dsi.com |
| Feb 17, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013923 | Thromboembolism |
Not provided
Not provided
| ID | Term |
|---|---|
| C552171 | edoxaban |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| OG003 | Cohort 2b: 45 mg Edoxaban | Participants who were 6 to < 12 years of age and received a single dose, oral suspension of 45 mg edoxaban. |
| OG004 | Cohort 3a: 0.7 mg/kg Edoxaban | Participants who were 2 to < 6 years of age and received a single dose, oral suspension of 0.7 mg/kg (cap 24 mg) edoxaban. |
| OG005 | Cohort 3b: 1.4 mg/kg Edoxaban | Participants who were 2 to < 6 years of age and received a single dose, oral suspension of 1.4 mg/kg (cap 45 mg) edoxaban. |
| OG006 | Cohort 4a: 0.75 mg/kg Edoxaban | Participants who were 6 months to <2 years of age and received a single dose, oral suspension of 0.75 mg/kg edoxaban. |
| OG007 | Cohort 4b: 1.5 mg/kg Edoxaban | Participants who were 6 months to <2 years of age and received a single dose, oral suspension of 1.5 mg/kg edoxaban. |
| OG008 | Cohort 5a: 0.4 mg/kg Edoxaban | Participants who were 0 to 6 months of age and received a single dose, oral suspension of 0.4 mg/kg edoxaban. |
| OG009 | Cohort 5b: 0.8 mg/kg Edoxaban | Participants who were 0 to 6 months of age and received a single dose, oral suspension of 0.8 mg/kg edoxaban. |
|
|
Participants who were 6 to < 12 years of age and received a single dose, oral suspension of 24 mg edoxaban.
| OG003 | Cohort 2b: 45 mg Edoxaban | Participants who were 6 to < 12 years of age and received a single dose, oral suspension of 45 mg edoxaban. |
| OG004 | Cohort 3a: 0.7 mg/kg Edoxaban | Participants who were 2 to < 6 years of age and received a single dose, oral suspension of 0.7 mg/kg (cap 24 mg) edoxaban. |
| OG005 | Cohort 3b: 1.4 mg/kg Edoxaban | Participants who were 2 to < 6 years of age and received a single dose, oral suspension of 1.4 mg/kg (cap 45 mg) edoxaban. |
| OG006 | Cohort 4a: 0.75 mg/kg Edoxaban | Participants who were 6 months to <2 years of age and received a single dose, oral suspension of 0.75 mg/kg edoxaban. |
| OG007 | Cohort 4b: 1.5 mg/kg Edoxaban | Participants who were 6 months to <2 years of age and received a single dose, oral suspension of 1.5 mg/kg edoxaban. |
| OG008 | Cohort 5a: 0.4 mg/kg Edoxaban | Participants who were 0 to 6 months of age and received a single dose, oral suspension of 0.4 mg/kg edoxaban. |
| OG009 | Cohort 5b: 0.8 mg/kg Edoxaban | Participants who were 0 to 6 months of age and received a single dose, oral suspension of 0.8 mg/kg edoxaban. |
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| OG003 | Cohort 2b: 45 mg Edoxaban | Participants who were 6 to < 12 years of age and received a single dose, oral suspension of 45 mg edoxaban. |
| OG004 | Cohort 3a: 0.7 mg/kg Edoxaban | Participants who were 2 to < 6 years of age and received a single dose, oral suspension of 0.7 mg/kg (cap 24 mg) edoxaban. |
| OG005 | Cohort 3b: 1.4 mg/kg Edoxaban | Participants who were 2 to < 6 years of age and received a single dose, oral suspension of 1.4 mg/kg (cap 45 mg) edoxaban. |
| OG006 | Cohort 4a: 0.75 mg/kg Edoxaban | Participants who were 6 months to <2 years of age and received a single dose, oral suspension of 0.75 mg/kg edoxaban. |
| OG007 | Cohort 4b: 1.5 mg/kg Edoxaban | Participants who were 6 months to <2 years of age and received a single dose, oral suspension of 1.5 mg/kg edoxaban. |
| OG008 | Cohort 5a: 0.4 mg/kg Edoxaban | Participants who were 0 to 6 months of age and received a single dose, oral suspension of 0.4 mg/kg edoxaban. |
| OG009 | Cohort 5b: 0.8 mg/kg Edoxaban | Participants who were 0 to 6 months of age and received a single dose, oral suspension of 0.8 mg/kg edoxaban. |
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| OG002 | Cohort 3a: 0.7 mg/kg Edoxaban | Participants who were 2 to < 6 years of age and received a single dose, oral suspension of 0.7 mg/kg (cap 24 mg) edoxaban. |
| OG003 | Cohort 3b: 1.4 mg/kg Edoxaban | Participants who were 2 to < 6 years of age and received a single dose, oral suspension of 1.4 mg/kg (cap 45 mg) edoxaban. |
| OG004 | Cohort 4a: 0.75 mg/kg Edoxaban | Participants who were 6 months to <2 years of age and received a single dose, oral suspension of 0.75 mg/kg edoxaban. |
| OG005 | Cohort 4b: 1.5 mg/kg Edoxaban | Participants who were 6 months to <2 years of age and received a single dose, oral suspension of 1.5 mg/kg edoxaban. |
| OG006 | Cohort 5a: 0.4 mg/kg Edoxaban | Participants who were 0 to 6 months of age and received a single dose, oral suspension of 0.4 mg/kg edoxaban. |
| OG007 | Cohort 5b: 0.8 mg/kg Edoxaban | Participants who were 0 to 6 months of age and received a single dose, oral suspension of 0.8 mg/kg edoxaban. |
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