Not provided
Not provided
Not provided
Not provided
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Not provided
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Not provided
Not provided
| Name | Class |
|---|---|
| Ontario Clinical Oncology Group (OCOG) | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to learn whether apixaban is well-tolerated and acceptable as anticoagulant therapy, when administered to patients with advanced or metastatic cancer and at increased risk for venous thromboembolic events. Demonstration of a favorable benefit:risk profile could lead to significant reduction in this serious and sometimes fatal complication of ongoing cancer and its treatment.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Placebo | Placebo Comparator | Participants received placebo tablets once daily |
|
| Cohort 1: Apixaban, 5 mg | Placebo Comparator | Participants received apixaban as tablet, 5 mg, once daily |
|
| Cohort 1: Apixaban, 10 mg | Active Comparator | Participants received apixaban as tablet, 10 mg, once daily |
|
| Cohort 1: Apixaban, 20 mg | Active Comparator | Participants received apixaban as tablet, 20 mg, once daily |
|
| Cohort 2: Placebo | Placebo Comparator | Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily. |
|
| Cohort 2: Apixaban, 5 mg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban | Drug | Oral tablets administered once daily in 5-, 10-, or 20-mg dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Composite of Confirmed Major Bleeding and Clinically Relevant Nonmajor (CRNM) Bleeding | Major bleeding was defined as clinically overt bleeding accompanied by 1 or more of the following:
CRNM bleeding was defined as bleeding that did not meet the criteria for major bleeding but that, in routine clinical practice, would be considered relevant and not trivial by a patient and physician. Such bleeding satisfied a priori criteria defined by the ICAC, including:
| From first dose to 2 days following last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Composite of Venous Thromboembolism (VTE) and All-cause Death | VTE includes symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE). Any 1 of the following was considered diagnostic for DVT:
Any 1 of the following was considered diagnostic for PE:
|
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Cancer Center | Tucson | Arizona | 85724 | United States | ||
| Univ. Of Southern Calif. /Norris Comprehensive Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34622445 | Derived | Kahale LA, Matar CF, Tsolakian I, Hakoum MB, Barba M, Yosuico VE, Terrenato I, Sperati F, Schunemann H, Akl EA. Oral anticoagulation in people with cancer who have no therapeutic or prophylactic indication for anticoagulation. Cochrane Database Syst Rev. 2021 Oct 8;10(10):CD006466. doi: 10.1002/14651858.CD006466.pub7. | |
| 33337539 |
Not provided
Not provided
A total of 130 participants were enrolled and randomized; however, 1 withdrew consent and 2 no longer met study criteria. Therefore, 127 participants were treated. Reasons Not Completed listed in the data table below were summarized for 127 participants who received treatment.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Placebo | Participants received placebo tablets once daily |
| FG001 | Cohort 1: Apixaban, 5 mg | Participants received apixaban as tablet, 5 mg, once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Active Comparator |
Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily. |
|
|
| Placebo | Drug | Oral tablets administered once daily |
|
| First dose to 2 days following last dose of study drug |
| Number of Participants With Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and All-cause Death | Any 1 of the following was considered diagnostic for DVT:
Any 1 of the following was considered diagnostic for PE:
| First dose to 30 days following last dose of study drug |
| Number of Participants With Composite of Venous Thromboembolism (VTE) and VTE-related Death | VTE includes symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE). Any 1 of the following was considered diagnostic for DVT:
Any 1 of the following was considered diagnostic for PE:
| First dose to 2 days following last dose of study drug |
| Number of Participants With Composite of Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and Venous Thromboembolism (VTE)-Related Death | VTE includes symptomatic DVT and PE. Any 1 of the following was considered diagnostic for DVT:
Any 1 of the following was considered diagnostic for PE:
| First dose to 2 days following last dose of study drug |
| Number of Participants With All-Cause Death | First dose to 2 days following last dose of study drug |
| Number of Participants With Pulmonary Embolism (Fatal or Nonfatal) | Any 1 of the following was considered diagnostic for PE:
| First dose to 2 days following last dose of study drug |
| Number of Participants With Nonfatal Pulmonary Embolism | Any 1 of the following was considered diagnostic for PE:
| First dose to 2 days following last dose of study drug |
| Number of Participants With Deep Vein Thrombosis | Any 1 of the following was considered diagnostic for DVT:
| First dose to 2 days following last dose of study drug |
| Number of Participants With Distal Deep Vein Thrombosis | Any 1 of the following was considered diagnostic for DVT:
| First dose to 2 days following last dose of study drug |
| Number of Participants With Proximal Deep Vein Thrombosis | Any 1 of the following was considered diagnostic for DVT:
| First dose to 2 days following last dose of study drug |
| Number of Participants Who Died and With Adverse Events (AEs), Serious Adverse Events (SAEs), Bleeding AEs, and Discontinuations Due to AEs | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. | First dose to 2 days following last dose of study drug |
| Los Angeles |
| California |
| 90033 |
| United States |
| Dana-Farber Cancer Inst | Boston | Massachusetts | 02115 | United States |
| Nevada Cancer Institute | Las Vegas | Nevada | 89135 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
| Mount Sinai School Of Medicine | New York | New York | 10029 | United States |
| University Of Rochester | Rochester | New York | 14642 | United States |
| University Of Texas Md Anderson Cancer Ctr | Houston | Texas | 77030 | United States |
| Local Institution | Hamilton | Ontario | L8V 2C5 | Canada |
| Local Institution | London | Ontario | N6A 4L6 | Canada |
| Local Institution | Toronto | Ontario | M4N 3M5 | Canada |
| Local Institution | Toronto | Ontario | M5G 2M9 | Canada |
| Local Institution | Montreal | Quebec | H1T 2M4 | Canada |
| Local Institution | Montreal | Quebec | H3G 1A4 | Canada |
| Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12(12):CD008500. doi: 10.1002/14651858.CD008500.pub5. |
| FG002 | Cohort 1: Apixaban, 10 mg | Participants received apixaban as tablet, 10 mg, once daily |
| FG003 | Cohort 1: Apixaban, 20 mg | Participants received apixaban as tablet, 20 mg, once daily |
| FG004 | Cohort 2: Placebo | Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily. |
| FG005 | Cohort 2: Apixaban, 5 mg | Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily. |
| Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All participants who were randomized to receive treatment
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Placebo | Participants received placebo tablets once daily |
| BG001 | Cohort 1: Apixaban, 5 mg | Participants received apixaban as tablet, 5 mg, once daily |
| BG002 | Cohort 1: Apixaban, 10 mg | Participants received apixaban as tablet, 10 mg, once daily |
| BG003 | Cohort 1: Apixaban, 20 mg | Participants received apixaban as tablet, 20 mg, once daily |
| BG004 | Cohort 2: Placebo | Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily. |
| BG005 | Cohort 2: Apixaban, 5 mg | Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily. |
| BG006 | 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, Customized | Number | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | 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 | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number of Participants With Composite of Venous Thromboembolism (VTE) and All-cause Death | VTE includes symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE). Any 1 of the following was considered diagnostic for DVT:
Any 1 of the following was considered diagnostic for PE:
| All participants who received at least 1 dose of study drug | Posted | Number | 95% Confidence Interval | Participants | First dose to 2 days following last dose of study drug |
|
|
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and All-cause Death | Any 1 of the following was considered diagnostic for DVT:
Any 1 of the following was considered diagnostic for PE:
| All participants who received at least 1 dose of study drug | Posted | Number | 95% Confidence Interval | Participants | First dose to 30 days following last dose of study drug |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Composite of Venous Thromboembolism (VTE) and VTE-related Death | VTE includes symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE). Any 1 of the following was considered diagnostic for DVT:
Any 1 of the following was considered diagnostic for PE:
| All participants who received at least 1 dose of study drug | Posted | Number | 95% Confidence Interval | Participants | First dose to 2 days following last dose of study drug |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Composite of Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and Venous Thromboembolism (VTE)-Related Death | VTE includes symptomatic DVT and PE. Any 1 of the following was considered diagnostic for DVT:
Any 1 of the following was considered diagnostic for PE:
| All participants who received at least 1 dose of study drug | Posted | Number | 95% Confidence Interval | Participants | First dose to 2 days following last dose of study drug |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With All-Cause Death | All participants who received at least 1 dose of study drug | Posted | Number | 95% Confidence Interval | Participants | First dose to 2 days following last dose of study drug |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Pulmonary Embolism (Fatal or Nonfatal) | Any 1 of the following was considered diagnostic for PE:
| All participants who received at least 1 dose of study drug | Posted | Number | 95% Confidence Interval | Participants | First dose to 2 days following last dose of study drug |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Nonfatal Pulmonary Embolism | Any 1 of the following was considered diagnostic for PE:
| Posted | Number | 95% Confidence Interval | Participants | First dose to 2 days following last dose of study drug |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Deep Vein Thrombosis | Any 1 of the following was considered diagnostic for DVT:
| All participants who received at least 1 dose of study drug | Posted | Number | 95% Confidence Interval | Participants | First dose to 2 days following last dose of study drug |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Distal Deep Vein Thrombosis | Any 1 of the following was considered diagnostic for DVT:
| All participants who received at least 1 dose of study drug | Posted | Number | 95% Confidence Interval | Participants | First dose to 2 days following last dose of study drug |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Proximal Deep Vein Thrombosis | Any 1 of the following was considered diagnostic for DVT:
| All participants who received at least 1 dose of study drug | Posted | Number | 95% Confidence Interval | Participants | First dose to 2 days following last dose of study drug |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Died and With Adverse Events (AEs), Serious Adverse Events (SAEs), Bleeding AEs, and Discontinuations Due to AEs | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. | All participants who received at least 1 dose of study drug | Posted | Number | Participants | First dose to 2 days following last dose of study drug |
| |||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Composite of Confirmed Major Bleeding and Clinically Relevant Nonmajor (CRNM) Bleeding | Major bleeding was defined as clinically overt bleeding accompanied by 1 or more of the following:
CRNM bleeding was defined as bleeding that did not meet the criteria for major bleeding but that, in routine clinical practice, would be considered relevant and not trivial by a patient and physician. Such bleeding satisfied a priori criteria defined by the ICAC, including:
| All participants who received at least 1 dose of study drug | Posted | Number | 95% Confidence Interval | Participants | From first dose to 2 days following last dose of study drug |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: Placebo | Participants received placebo tablets once daily | 9 | 29 | 24 | 29 | ||
| EG001 | Cohort 1: Apixaban, 5 mg | Participants received apixaban as tablet, 5 mg, once daily | 6 | 32 | 28 | 32 | ||
| EG002 | Cohort 1: Apixaban, 10 mg | Participants received apixaban as tablet, 10 mg, once daily | 3 | 29 | 24 | 29 | ||
| EG003 | Cohort 1: Apixaban, 20 mg | Participants received apixaban as tablet, 20 mg, once daily | 5 | 32 | 30 | 32 | ||
| EG004 | Cohort 2: Placebo | Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily. | 1 | 2 | 2 | 2 | ||
| EG005 | Cohort : Apixaban, 5 mg | :Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily. | 0 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Hip arthroplasty | Surgical and medical procedures | MedDRA 11.1 | Systematic Assessment |
| |
| Lower gastrointestinal tract hemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Peptic ulcer perforation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Spinal decompression | Surgical and medical procedures | MedDRA 11.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Anal haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nervousness | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Blood magnesium decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pilonidal cyst | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Early satiety | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 11.1 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 11.1 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D009369 | Neoplasms |
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
Not provided
Not provided
| ID | Term |
|---|---|
| C522181 | apixaban |
Not provided
Not provided
Not provided
| 65 years and older but younger than 75 years |
|
| 75 years and older |
|
| Male |
|
| Black/African American |
|
| Asian |
|
| Native Hawaiian or other Pacific Islander |
|
| Other |
|
| OG002 | Cohort 1: Apixaban, 10 mg | Participants received apixaban as tablet, 10 mg, once daily |
| OG003 | Cohort 1: Apixaban, 20 mg | Participants received apixaban as tablet, 20 mg, once daily |
| OG004 | Cohort 2: Placebo | Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily. |
| OG005 | Cohort 2: Apixaban, 5 mg | Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily. |
|
|
| OG002 | Cohort 1: Apixaban, 10 mg | Participants received apixaban as tablet, 10 mg, once daily |
| OG003 | Cohort 1: Apixaban, 20 mg | Participants received apixaban as tablet, 20 mg, once daily |
| OG004 | Cohort 2: Placebo | Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily. |
| OG005 | Cohort 2: Apixaban, 5 mg | Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily. |
|
|
| OG002 | Cohort 1: Apixaban, 10 mg | Participants received apixaban as tablet, 10 mg, once daily |
| OG003 | Cohort 1: Apixaban, 20 mg | Participants received apixaban as tablet, 20 mg, once daily |
| OG004 | Cohort 2: Placebo | Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily. |
| OG005 | Cohort 2: Apixaban, 5 mg | Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily. |
|
|
| OG005 | Cohort 2: Apixaban, 5 mg | Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily. |
|
|
| Cohort 1: Apixaban, 20 mg |
Participants received apixaban as tablet, 20 mg, once daily |
| OG004 | Cohort 2: Placebo | Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily. |
| OG005 | Cohort 2: Apixiban, 5 mg | Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily. |
|
|
Participants received apixaban as tablet, 20 mg, once daily
| OG004 | Cohort 2: Placebo | Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily. |
| OG005 | Cohort 2: Apixaban, 5 mg | Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily. |
|
|
| OG004 | Cohort 2: Placebo | Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily. |
| OG005 | Cohort 2: Apixaban, 5 mg | Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily. |
|
|
| OG004 | Cohort 2: Placebo | Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily. |
| OG005 | Cohort 2: Apixaban, 5 mg | Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily. |
|
|
| OG004 | Cohort 2: Placebo | Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily. |
| OG005 | Cohort 2: Apixaban, 5 mg | Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily. |
|
|
Participants received apixaban as tablet, 20 mg, once daily |
| OG004 | Cohort 2: Placebo | Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily. |
| OG005 | Cohort 2: Apixaban, 5 mg | Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily. |
|
|
| OG002 |
| Cohort 1: Apixaban, 10 mg |
Participants received apixaban as tablet, 10 mg, once daily |
| OG003 | Cohort 1: Apixaban, 20 mg | Participants received apixaban as tablet, 20 mg, once daily |
| OG004 | Cohort 2: Placebo | Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily. |
| OG005 | Cohort 2: Apixaban, 5 mg | Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily. |
|
|