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This study is requested by PMDA to confirm the efficacy and the safety for HFS.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fondaparinux | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Major Bleeding During Treatment Period | Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of venous thromboembolic events (VTE) included, but were not limited to lower extremity deep vein thrombosis (DVT): erythema, warmth, pain, swelling, tenderness and pulmonary embolism (PE): pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the Central Independent Adjudication Committee of Efficacy (CIACE). | From the first study drug injection up to Day 17 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of PE During Treatment Period | Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity PE: pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site |
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Total of 48 participants undergoing major orthopedic surgery of the lower limb such as hip fracture surgery, knee replacement surgery and hip replacement surgery were enrolled from 16 February 2006 to 26 October 2006 at 9 centers in Japan. The safety population consisted of 48 participants and full analysis set consisted of 37 participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fondaparinux Sodium 2.5 mg s.c. | Participants received fondaparinux sodium 2.5 milligrams (mg) by subcutaneous (s.c.) injection for 14 days between Day 2 to Day 11-15. The first injection of the study drug was given 24 ± 2 hours after surgical closure. From Day 3 onwards, the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fondaparinux Sodium 2.5 mg s.c. | Participants received fondaparinux sodium 2.5 mg by s.c. injection for 14 days between Day 2 to Day 11-15. The first injection of the study drug was given 24 ± 2 hours after surgical closure. From Day 3 onwards, the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Rate of Major Bleeding During Treatment Period | Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of venous thromboembolic events (VTE) included, but were not limited to lower extremity deep vein thrombosis (DVT): erythema, warmth, pain, swelling, tenderness and pulmonary embolism (PE): pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the Central Independent Adjudication Committee of Efficacy (CIACE). | Full analysis set used which consisted of all participants who were assigned to study drug with the exception of those who did not receive study drug at all and those with no valid efficacy data (example no evaluable venogram). | Posted | Number | 95% Confidence Interval | % of normalized events per participant | From the first study drug injection up to Day 17 |
|
AE and SAE were reported throughout the study (from the first study drug injection up to 2 days after the last study drug injection [approximately up to Day 17]).
Safety population was used for reporting AE and SAE.
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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 | Fondaparinux Sodium 2.5 mg s.c. | Participants received fondaparinux sodium 2.5 mg by s.c. injection for 14 days between Day 2 to Day 11-15. The first injection of the study drug was given 24 ± 2 hours after surgical closure. From Day 3 onwards, the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ileus | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077425 | Fondaparinux |
| ID | Term |
|---|---|
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Up to Day 17 |
| Rate of DVT During Treatment Period | Rate (%) was defined as number of events divided by the number of patients evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first. | Up to Day 17 |
| Rate of Proximal DVT During Treatment Period | Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first. | Up to Day 17 |
| Rate of Distal Only DVT During Treatment Period | Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first. | Up to Day 17 |
| Number of Participants With Major Bleeding During Treatment Period | Major bleeding events were defined as clinically unusual bleeding meeting any of the following criteria: fatal bleeding, bleeding including retroperitoneal and intracranial bleeding or bleeding into a critical organ (eye, adrenal gland, pericardium, spine), reoperation due to bleeding/hematoma at the operative site, bleeding leading to a hemoglobin (Hb) fall >=2 grams per deciliter (g/dL, 1.6 millimoles per liter [mmol/L]) within 48 hour of the bleed, bleeding that required a transfusion of red blood cell or whole blood derived from >=900 millilters (mL) of whole blood within 48 hours of the bleed (excluding the autologous transfusion except for the treatment of bleeding adverse event (AE) and bleeding leading to the bleeding index (BI) >=2. Major bleeding events were adjudicated by the Central Independent Adjudication Committee of Safety (CIACS). | From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17) |
| Number of Participants With Minor Bleeding and Any Bleeding (Major and/or Minor Bleeding) | Minor bleeding and any bleeding (major and/or minor bleeding) events were adjudicated by the CIACS. Minor bleeding was defined as clinically overt bleeding not meeting the criteria for major bleeding and considered more than expected in the clinical context. Any bleeding (major and/or minor bleeding) could be recorded may be major and/or minor. | From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17) |
| Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Death | An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition. | From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17) |
| Number of Transfused Participants | Blood product transfusions consisted of packed red blood cells or fresh frozen plasma or both. This was done between Day 2 and 2 calendar days after the last injection. | From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17) |
| Summary of Units Transfused | Blood product transfusions consisted of packed red blood cells or fresh frozen plasma or both. This was done between Day 2 and 2 calendar days after the last injection. | From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17) |
| Rate of Symptomatic DVT | Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first. | Up to Day 17 |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | Fondaparinux Sodium 2.5 mg s.c. | Participants received fondaparinux sodium 2.5 mg by s.c. injection for 14 days between Day 2 to Day 11-15. The first injection of the study drug was given 24 ± 2 hours after surgical closure. From Day 3 onwards, the injection of the study drug was given at about the same time every day as far as possible (but more than 12 hours after the first dose on Day 2). |
|
|
| Secondary | Rate of PE During Treatment Period | Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity PE: pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first. | Safety population used which consisted of all participants who received at least one dose of study drug. | Posted | Number | 95% Confidence Interval | % of normalized events per participant | Up to Day 17 |
|
|
|
| Secondary | Rate of DVT During Treatment Period | Rate (%) was defined as number of events divided by the number of patients evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first. | Efficacy evaluable participants used consisted of a subpopulation of safety population who were judged to be evaluable for all DVT and proximal DVT or distal only DVT by the site of occurrence (total/side of operation/opposite side of operation/both sides). Only those participants with data available at the indicated time points were analyzed. | Posted | Number | % of normalized events per participant | Up to Day 17 |
|
|
|
| Secondary | Rate of Proximal DVT During Treatment Period | Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first. | Efficacy evaluable participants used. Only those participants with data available at the indicated time points were analyzed. | Posted | Number | % of normalized events per participant | Up to Day 17 |
|
|
|
| Secondary | Rate of Distal Only DVT During Treatment Period | Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first. | Efficacy evaluable participants used. Only those participants with data available at the indicated time points were analyzed. | Posted | Number | % of normalized events per participant | Up to Day 17 |
|
|
|
| Secondary | Number of Participants With Major Bleeding During Treatment Period | Major bleeding events were defined as clinically unusual bleeding meeting any of the following criteria: fatal bleeding, bleeding including retroperitoneal and intracranial bleeding or bleeding into a critical organ (eye, adrenal gland, pericardium, spine), reoperation due to bleeding/hematoma at the operative site, bleeding leading to a hemoglobin (Hb) fall >=2 grams per deciliter (g/dL, 1.6 millimoles per liter [mmol/L]) within 48 hour of the bleed, bleeding that required a transfusion of red blood cell or whole blood derived from >=900 millilters (mL) of whole blood within 48 hours of the bleed (excluding the autologous transfusion except for the treatment of bleeding adverse event (AE) and bleeding leading to the bleeding index (BI) >=2. Major bleeding events were adjudicated by the Central Independent Adjudication Committee of Safety (CIACS). | Safety population used. | Posted | Count of Participants | Participants | From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17) |
|
|
|
| Secondary | Number of Participants With Minor Bleeding and Any Bleeding (Major and/or Minor Bleeding) | Minor bleeding and any bleeding (major and/or minor bleeding) events were adjudicated by the CIACS. Minor bleeding was defined as clinically overt bleeding not meeting the criteria for major bleeding and considered more than expected in the clinical context. Any bleeding (major and/or minor bleeding) could be recorded may be major and/or minor. | Safety population used. | Posted | Count of Participants | Participants | From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17) |
|
|
|
| Secondary | Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Death | An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition. | Safety population used. | Posted | Count of Participants | Participants | From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17) |
|
|
|
| Secondary | Number of Transfused Participants | Blood product transfusions consisted of packed red blood cells or fresh frozen plasma or both. This was done between Day 2 and 2 calendar days after the last injection. | Safety population used. | Posted | Count of Participants | Participants | From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17) |
|
|
|
| Secondary | Summary of Units Transfused | Blood product transfusions consisted of packed red blood cells or fresh frozen plasma or both. This was done between Day 2 and 2 calendar days after the last injection. | Safety population used. | Posted | Number | mL | From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17) |
|
|
|
| Secondary | Rate of Symptomatic DVT | Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first. | Safety population used. | Posted | Number | % of normalized events per participant | Up to Day 17 |
|
|
|
| 0 |
| 48 |
| 2 |
| 48 |
| 37 |
| 48 |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA version | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA version | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA version | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA version | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA version | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA version | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA version | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA version | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA version | Systematic Assessment |
|
| C reactive protein increased | Investigations | MedDRA version | Systematic Assessment |
|
| Platelet count increased | Investigations | MedDRA version | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA version | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA version | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Measurements |
|---|
|