Trial Outcomes & Findings for A Phase 2 Pilot Study of Apixaban for the Prevention of Thromboembolic Events in Patients With Advanced (Metastatic) Cancer (NCT NCT00320255)
NCT ID: NCT00320255
Last Updated: 2016-08-16
Results Overview
Major bleeding was defined as clinically overt bleeding accompanied by 1 or more of the following: * A decrease in hemoglobin of 20 g/L or more or * Required transfusion of 2 or more units of packed red blood cells or whole blood, or * Occurred in a critical site * Contributed to death. 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: * Skin hematoma * Epistaxis that lasted for longer than 5 minutes, was repetitive, or led to an intervention * Hematuria that was macroscopic and either spontaneous or lasted for longer than 24 hours after instrumentation of the urogenital tract * Any other bleeding type that was considered to have clinical consequences.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
130 participants
Primary outcome timeframe
From first dose to 2 days following last dose of study drug
Results posted on
2016-08-16
Participant Flow
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.
Participant milestones
| Measure |
Cohort 1: Placebo
Participants received placebo tablets once daily
|
Cohort 1: Apixaban, 5 mg
Participants received apixaban as tablet, 5 mg, once daily
|
Cohort 1: Apixaban, 10 mg
Participants received apixaban as tablet, 10 mg, once daily
|
Cohort 1: Apixaban, 20 mg
Participants received apixaban as tablet, 20 mg, once daily
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
32
|
30
|
33
|
2
|
3
|
|
Overall Study
Received Treatment
|
29
|
32
|
29
|
32
|
2
|
3
|
|
Overall Study
COMPLETED
|
19
|
25
|
24
|
25
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
11
|
7
|
6
|
8
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1: Placebo
Participants received placebo tablets once daily
|
Cohort 1: Apixaban, 5 mg
Participants received apixaban as tablet, 5 mg, once daily
|
Cohort 1: Apixaban, 10 mg
Participants received apixaban as tablet, 10 mg, once daily
|
Cohort 1: Apixaban, 20 mg
Participants received apixaban as tablet, 20 mg, once daily
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
5
|
2
|
3
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
2
|
4
|
0
|
0
|
|
Overall Study
Poor compliance/noncompliance
|
1
|
1
|
0
|
1
|
0
|
0
|
|
Overall Study
No longer meets study criteria
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Other
|
3
|
2
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Phase 2 Pilot Study of Apixaban for the Prevention of Thromboembolic Events in Patients With Advanced (Metastatic) Cancer
Baseline characteristics by cohort
| Measure |
Cohort 1: Placebo
n=30 Participants
Participants received placebo tablets once daily
|
Cohort 1: Apixaban, 5 mg
n=32 Participants
Participants received apixaban as tablet, 5 mg, once daily
|
Cohort 1: Apixaban, 10 mg
n=30 Participants
Participants received apixaban as tablet, 10 mg, once daily
|
Cohort 1: Apixaban, 20 mg
n=33 Participants
Participants received apixaban as tablet, 20 mg, once daily
|
Cohort 2: Placebo
n=2 Participants
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
n=3 Participants
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.
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
Younger than 65 years
|
17 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
85 Participants
n=8 Participants
|
|
Age, Customized
65 years and older but younger than 75 years
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
30 Participants
n=8 Participants
|
|
Age, Customized
75 years and older
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
64 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
66 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
110 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From first dose to 2 days following last dose of study drugPopulation: All participants who received at least 1 dose of study drug
Major bleeding was defined as clinically overt bleeding accompanied by 1 or more of the following: * A decrease in hemoglobin of 20 g/L or more or * Required transfusion of 2 or more units of packed red blood cells or whole blood, or * Occurred in a critical site * Contributed to death. 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: * Skin hematoma * Epistaxis that lasted for longer than 5 minutes, was repetitive, or led to an intervention * Hematuria that was macroscopic and either spontaneous or lasted for longer than 24 hours after instrumentation of the urogenital tract * Any other bleeding type that was considered to have clinical consequences.
Outcome measures
| Measure |
Cohort 1: Placebo
n=29 Participants
Participants received placebo tablets once daily
|
Cohort 1: Apixaban, 5 mg
n=32 Participants
Participants received apixaban as tablet, 5 mg, once daily
|
Cohort 1: Apixaban, 10 mg
n=29 Participants
Participants received apixaban as tablet, 10 mg, once daily
|
Cohort 1: Apixaban, 20 mg
n=32 Participants
Participants received apixaban as tablet, 20 mg, once daily
|
Cohort 2: Placebo
n=2 Participants
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
n=3 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Composite of Confirmed Major Bleeding and Clinically Relevant Nonmajor (CRNM) Bleeding
|
1 Participants
Interval 0.1 to 17.8
|
1 Participants
Interval 0.1 to 16.2
|
1 Participants
Interval 0.1 to 17.8
|
4 Participants
Interval 3.5 to 29.0
|
2 Participants
No statistical analyses were conducted for Cohort 2.
|
3 Participants
No statistical analyses were conducted for Cohort 2.
|
SECONDARY outcome
Timeframe: First dose to 2 days following last dose of study drugPopulation: All participants who received at least 1 dose of study drug
VTE includes symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE). Any 1 of the following was considered diagnostic for DVT: * New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS * Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava. Any 1 of the following was considered diagnostic for PE: * Constant intraluminal filling defects in 2 or more views on pulmonary angiography * Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram * A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect) * An abnormal VQ lung scan with satisfaction of either criterion 1 or 2 * Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels.
Outcome measures
| Measure |
Cohort 1: Placebo
n=29 Participants
Participants received placebo tablets once daily
|
Cohort 1: Apixaban, 5 mg
n=32 Participants
Participants received apixaban as tablet, 5 mg, once daily
|
Cohort 1: Apixaban, 10 mg
n=29 Participants
Participants received apixaban as tablet, 10 mg, once daily
|
Cohort 1: Apixaban, 20 mg
n=32 Participants
Participants received apixaban as tablet, 20 mg, once daily
|
Cohort 2: Placebo
n=2 Participants
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
n=3 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Composite of Venous Thromboembolism (VTE) and All-cause Death
|
4 Participants
Interval 3.9 to 31.7
|
0 Participants
Interval 0.0 to 10.9
|
0 Participants
Interval 0.0 to 11.9
|
1 Participants
Interval 0.1 to 16.2
|
0 Participants
No statistical analyses were conducted for Cohort 2.
|
0 Participants
No statistical analyses were conducted for Cohort 2.
|
SECONDARY outcome
Timeframe: First dose to 30 days following last dose of study drugPopulation: All participants who received at least 1 dose of study drug
Any 1 of the following was considered diagnostic for DVT: * New or previously undocumented noncompressibility of 1 or more proximal venous segments (popliteal vein or higher) of the legs on CUS * Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava. Any 1 of the following was considered diagnostic for PE: * Constant intraluminal filling defects in 2 or more views on pulmonary angiography * Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram * A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect) * An abnormal VQ lung scan (nonhigh probability) with satisfaction of either criterion 1 or 2 * Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels.
Outcome measures
| Measure |
Cohort 1: Placebo
n=29 Participants
Participants received placebo tablets once daily
|
Cohort 1: Apixaban, 5 mg
n=32 Participants
Participants received apixaban as tablet, 5 mg, once daily
|
Cohort 1: Apixaban, 10 mg
n=29 Participants
Participants received apixaban as tablet, 10 mg, once daily
|
Cohort 1: Apixaban, 20 mg
n=32 Participants
Participants received apixaban as tablet, 20 mg, once daily
|
Cohort 2: Placebo
n=2 Participants
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
n=3 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and All-cause Death
|
3 Participants
Interval 2.2 to 27.4
|
0 Participants
Interval 0.0 to 10.9
|
0 Participants
Interval 0.0 to 11.9
|
0 Participants
Interval 0.0 to 10.9
|
0 Participants
No statistical analyses were conducted for Cohort 2.
|
0 Participants
No statistical analyses were conducted for Cohort 2.
|
SECONDARY outcome
Timeframe: First dose to 2 days following last dose of study drugPopulation: All participants who received at least 1 dose of study drug
VTE includes symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE). Any 1 of the following was considered diagnostic for DVT: * New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS * Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava. Any 1 of the following was considered diagnostic for PE: * Constant intraluminal filling defects in 2 or more views on pulmonary angiography * Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram * A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect) * An abnormal VQ lung scan with satisfaction of either criterion 1 or 2 * Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels.
Outcome measures
| Measure |
Cohort 1: Placebo
n=29 Participants
Participants received placebo tablets once daily
|
Cohort 1: Apixaban, 5 mg
n=32 Participants
Participants received apixaban as tablet, 5 mg, once daily
|
Cohort 1: Apixaban, 10 mg
n=29 Participants
Participants received apixaban as tablet, 10 mg, once daily
|
Cohort 1: Apixaban, 20 mg
n=32 Participants
Participants received apixaban as tablet, 20 mg, once daily
|
Cohort 2: Placebo
n=2 Participants
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
n=3 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Composite of Venous Thromboembolism (VTE) and VTE-related Death
|
4 Participants
Interval 3.9 to 31.7
|
0 Participants
Interval 0.0 to 10.9
|
0 Participants
Interval 0.0 to 11.9
|
1 Participants
Interval 0.1 to 16.2
|
0 Participants
No statistical analyses were conducted for Cohort 2.
|
0 Participants
No statistical analyses were conducted for Cohort 2.
|
SECONDARY outcome
Timeframe: First dose to 2 days following last dose of study drugPopulation: All participants who received at least 1 dose of study drug
VTE includes symptomatic DVT and PE. Any 1 of the following was considered diagnostic for DVT: * New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS * Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava. Any 1 of the following was considered diagnostic for PE: * Constant intraluminal filling defects in 2 or more views on pulmonary angiography * Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram * A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect) * An abnormal VQ lung scan with satisfaction of either criterion 1 or 2 * Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels.
Outcome measures
| Measure |
Cohort 1: Placebo
n=29 Participants
Participants received placebo tablets once daily
|
Cohort 1: Apixaban, 5 mg
n=32 Participants
Participants received apixaban as tablet, 5 mg, once daily
|
Cohort 1: Apixaban, 10 mg
n=29 Participants
Participants received apixaban as tablet, 10 mg, once daily
|
Cohort 1: Apixaban, 20 mg
n=32 Participants
Participants received apixaban as tablet, 20 mg, once daily
|
Cohort 2: Placebo
n=2 Participants
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
n=3 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Composite of Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and Venous Thromboembolism (VTE)-Related Death
|
3 Participants
Interval 2.2 to 27.4
|
0 Participants
Interval 0.0 to 10.9
|
0 Participants
Interval 0.0 to 11.9
|
0 Participants
Interval 0.0 to 10.9
|
0 Participants
No statistical analyses were conducted for Cohort 2.
|
0 Participants
No statistical analyses were conducted for Cohort 2.
|
SECONDARY outcome
Timeframe: First dose to 2 days following last dose of study drugPopulation: All participants who received at least 1 dose of study drug
Outcome measures
| Measure |
Cohort 1: Placebo
n=29 Participants
Participants received placebo tablets once daily
|
Cohort 1: Apixaban, 5 mg
n=32 Participants
Participants received apixaban as tablet, 5 mg, once daily
|
Cohort 1: Apixaban, 10 mg
n=29 Participants
Participants received apixaban as tablet, 10 mg, once daily
|
Cohort 1: Apixaban, 20 mg
n=32 Participants
Participants received apixaban as tablet, 20 mg, once daily
|
Cohort 2: Placebo
n=2 Participants
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
n=3 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Participants With All-Cause Death
|
0 Participants
Interval 0.0 to 11.9
|
0 Participants
Interval 0.0 to 10.9
|
0 Participants
Interval 0.0 to 11.9
|
0 Participants
Interval 0.0 to 10.9
|
0 Participants
No statistical analyses were conducted for Cohort 2.
|
0 Participants
No statistical analyses were conducted for Cohort 2.
|
SECONDARY outcome
Timeframe: First dose to 2 days following last dose of study drugPopulation: All participants who received at least 1 dose of study drug
Any 1 of the following was considered diagnostic for PE: * Constant intraluminal filling defects in 2 or more views on pulmonary angiography * Sudden contrast cutoff of 1 or more vessels of greater than 2.5 mm in diameter on a pulmonary angiogram * A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect) * An abnormal VQ lung scan with satisfaction of either criterion 1 or 2 * Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels.
Outcome measures
| Measure |
Cohort 1: Placebo
n=29 Participants
Participants received placebo tablets once daily
|
Cohort 1: Apixaban, 5 mg
n=32 Participants
Participants received apixaban as tablet, 5 mg, once daily
|
Cohort 1: Apixaban, 10 mg
n=29 Participants
Participants received apixaban as tablet, 10 mg, once daily
|
Cohort 1: Apixaban, 20 mg
n=32 Participants
Participants received apixaban as tablet, 20 mg, once daily
|
Cohort 2: Placebo
n=2 Participants
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
n=3 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Pulmonary Embolism (Fatal or Nonfatal)
|
1 Participants
Interval 0.1 to 17.8
|
0 Participants
Interval 0.0 to 10.9
|
0 Participants
Interval 0.0 to 11.9
|
0 Participants
Interval 0.0 to 10.9
|
0 Participants
No statistical analyses were conducted for Cohort 2.
|
0 Participants
No statistical analyses were conducted for Cohort 2.
|
SECONDARY outcome
Timeframe: First dose to 2 days following last dose of study drugAny 1 of the following was considered diagnostic for PE: * Constant intraluminal filling defects in 2 or more views on pulmonary angiography * Sudden contrast cutoff of 1 or more vessels more than 2.5 mm in diameter on a pulmonary angiogram * A high probability VQ lung scan showing 1 or more segmental perfusion defects with corresponding normal ventilation (mismatch defect) * An abnormal VQ lung scan with satisfaction of either criterion 1 or 2 * Abnormal spiral computed tomography scan showing thrombus in pulmonary vessels.
Outcome measures
| Measure |
Cohort 1: Placebo
n=29 Participants
Participants received placebo tablets once daily
|
Cohort 1: Apixaban, 5 mg
n=32 Participants
Participants received apixaban as tablet, 5 mg, once daily
|
Cohort 1: Apixaban, 10 mg
n=29 Participants
Participants received apixaban as tablet, 10 mg, once daily
|
Cohort 1: Apixaban, 20 mg
n=32 Participants
Participants received apixaban as tablet, 20 mg, once daily
|
Cohort 2: Placebo
n=2 Participants
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
n=3 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Nonfatal Pulmonary Embolism
|
1 Participants
Interval 0.1 to 17.8
|
0 Participants
Interval 0.0 to 10.9
|
0 Participants
Interval 0.0 to 11.9
|
0 Participants
Interval 0.0 to 10.9
|
0 Participants
No statistical analyses were conducted for Cohort 2.
|
0 Participants
No statistical analyses were conducted for Cohort 2.
|
SECONDARY outcome
Timeframe: First dose to 2 days following last dose of study drugPopulation: All participants who received at least 1 dose of study drug
Any 1 of the following was considered diagnostic for DVT: * New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS * Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.
Outcome measures
| Measure |
Cohort 1: Placebo
n=29 Participants
Participants received placebo tablets once daily
|
Cohort 1: Apixaban, 5 mg
n=32 Participants
Participants received apixaban as tablet, 5 mg, once daily
|
Cohort 1: Apixaban, 10 mg
n=29 Participants
Participants received apixaban as tablet, 10 mg, once daily
|
Cohort 1: Apixaban, 20 mg
n=32 Participants
Participants received apixaban as tablet, 20 mg, once daily
|
Cohort 2: Placebo
n=2 Participants
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
n=3 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Deep Vein Thrombosis
|
4 Participants
Interval 3.9 to 31.7
|
0 Participants
Interval 0.0 to 10.9
|
0 Participants
Interval 0.0 to 11.9
|
1 Participants
Interval 0.1 to 16.2
|
0 Participants
No statistical analyses were conducted for Cohort 2.
|
0 Participants
No statistical analyses were conducted for Cohort 2.
|
SECONDARY outcome
Timeframe: First dose to 2 days following last dose of study drugPopulation: All participants who received at least 1 dose of study drug
Any 1 of the following was considered diagnostic for DVT: * New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS * Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.
Outcome measures
| Measure |
Cohort 1: Placebo
n=29 Participants
Participants received placebo tablets once daily
|
Cohort 1: Apixaban, 5 mg
n=32 Participants
Participants received apixaban as tablet, 5 mg, once daily
|
Cohort 1: Apixaban, 10 mg
n=29 Participants
Participants received apixaban as tablet, 10 mg, once daily
|
Cohort 1: Apixaban, 20 mg
n=32 Participants
Participants received apixaban as tablet, 20 mg, once daily
|
Cohort 2: Placebo
n=2 Participants
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
n=3 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Distal Deep Vein Thrombosis
|
1 Participants
Interval 0.1 to 17.8
|
0 Participants
Interval 0.0 to 10.9
|
0 Participants
Interval 0.0 to 11.9
|
0 Participants
Interval 0.0 to 10.9
|
0 Participants
No statistical analyses were conducted for Cohort 2.
|
0 Participants
No statistical analyses were conducted for Cohort 2.
|
SECONDARY outcome
Timeframe: First dose to 2 days following last dose of study drugPopulation: All participants who received at least 1 dose of study drug
Any 1 of the following was considered diagnostic for DVT: * New or previously undocumented noncompressibility of 1 or more proximal venous segments of the legs on CUS * Constant intraluminal filling defects on 2 or more views on contrast venography in 1 or more venous segments in the legs or pelvis or involving the inferior vena cava.
Outcome measures
| Measure |
Cohort 1: Placebo
n=29 Participants
Participants received placebo tablets once daily
|
Cohort 1: Apixaban, 5 mg
n=32 Participants
Participants received apixaban as tablet, 5 mg, once daily
|
Cohort 1: Apixaban, 10 mg
n=29 Participants
Participants received apixaban as tablet, 10 mg, once daily
|
Cohort 1: Apixaban, 20 mg
n=32 Participants
Participants received apixaban as tablet, 20 mg, once daily
|
Cohort 2: Placebo
n=2 Participants
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
n=3 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Proximal Deep Vein Thrombosis
|
3 Participants
Interval 2.2 to 27.4
|
0 Participants
Interval 0.0 to 10.9
|
0 Participants
Interval 0.0 to 11.9
|
0 Participants
Interval 0.0 to 10.9
|
0 Participants
No statistical analyses were conducted for Cohort 2.
|
0 Participants
No statistical analyses were conducted for Cohort 2.
|
SECONDARY outcome
Timeframe: First dose to 2 days following last dose of study drugPopulation: All participants who received at least 1 dose of study drug
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.
Outcome measures
| Measure |
Cohort 1: Placebo
n=29 Participants
Participants received placebo tablets once daily
|
Cohort 1: Apixaban, 5 mg
n=32 Participants
Participants received apixaban as tablet, 5 mg, once daily
|
Cohort 1: Apixaban, 10 mg
n=29 Participants
Participants received apixaban as tablet, 10 mg, once daily
|
Cohort 1: Apixaban, 20 mg
n=32 Participants
Participants received apixaban as tablet, 20 mg, once daily
|
Cohort 2: Placebo
n=2 Participants
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
n=3 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Died and With Adverse Events (AEs), Serious Adverse Events (SAEs), Bleeding AEs, and Discontinuations Due to AEs
Bleeding AEs
|
6 Participants
|
15 Participants
|
11 Participants
|
12 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Who Died and With Adverse Events (AEs), Serious Adverse Events (SAEs), Bleeding AEs, and Discontinuations Due to AEs
Deaths
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Died and With Adverse Events (AEs), Serious Adverse Events (SAEs), Bleeding AEs, and Discontinuations Due to AEs
SAEs
|
9 Participants
|
6 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Died and With Adverse Events (AEs), Serious Adverse Events (SAEs), Bleeding AEs, and Discontinuations Due to AEs
Discontinuations due to AEs
|
7 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Cohort 1: Placebo
Serious events: 9 serious events
Other events: 24 other events
Deaths: 0 deaths
Cohort 1: Apixaban, 5 mg
Serious events: 6 serious events
Other events: 28 other events
Deaths: 0 deaths
Cohort 1: Apixaban, 10 mg
Serious events: 3 serious events
Other events: 24 other events
Deaths: 0 deaths
Cohort 1: Apixaban, 20 mg
Serious events: 5 serious events
Other events: 30 other events
Deaths: 0 deaths
Cohort 2: Placebo
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort : Apixaban, 5 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: Placebo
n=29 participants at risk
Participants received placebo tablets once daily
|
Cohort 1: Apixaban, 5 mg
n=32 participants at risk
Participants received apixaban as tablet, 5 mg, once daily
|
Cohort 1: Apixaban, 10 mg
n=29 participants at risk
Participants received apixaban as tablet, 10 mg, once daily
|
Cohort 1: Apixaban, 20 mg
n=32 participants at risk
Participants received apixaban as tablet, 20 mg, once daily
|
Cohort 2: Placebo
n=2 participants at risk
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 : Apixaban, 5 mg
n=3 participants at risk
: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.
|
|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
3.4%
1/29
|
0.00%
0/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Infections and infestations
Pneumonia
|
0.00%
0/29
|
3.1%
1/32
|
0.00%
0/29
|
3.1%
1/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Abdominal pain
|
3.4%
1/29
|
0.00%
0/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/29
|
3.1%
1/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/29
|
3.1%
1/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/29
|
3.1%
1/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.9%
2/29
|
0.00%
0/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/29
|
3.1%
1/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.4%
1/29
|
0.00%
0/32
|
0.00%
0/29
|
3.1%
1/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/29
|
3.1%
1/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
6.9%
2/29
|
0.00%
0/32
|
0.00%
0/29
|
0.00%
0/32
|
50.0%
1/2
|
0.00%
0/3
|
|
General disorders
Death
|
3.4%
1/29
|
0.00%
0/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Duodenal ulcer
|
3.4%
1/29
|
0.00%
0/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Nausea
|
3.4%
1/29
|
0.00%
0/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/29
|
3.1%
1/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/29
|
3.1%
1/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Infections and infestations
Sepsis
|
0.00%
0/29
|
0.00%
0/32
|
3.4%
1/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/29
|
3.1%
1/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Investigations
Liver function test abnormal
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/29
|
3.1%
1/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/29
|
0.00%
0/32
|
3.4%
1/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Cardiac disorders
Cardiac failure congestive
|
3.4%
1/29
|
3.1%
1/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/29
|
3.1%
1/32
|
3.4%
1/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/29
|
3.1%
1/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/29
|
3.1%
1/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Lower gastrointestinal tract hemorrhage
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/29
|
3.1%
1/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Infections and infestations
Bacterial infection
|
3.4%
1/29
|
0.00%
0/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Vascular disorders
Deep vein thrombosis
|
3.4%
1/29
|
0.00%
0/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
General disorders
Disease progression
|
0.00%
0/29
|
3.1%
1/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/29
|
3.1%
1/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Infections and infestations
Viral infection
|
3.4%
1/29
|
0.00%
0/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/29
|
3.1%
1/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Infections and infestations
Infection
|
10.3%
3/29
|
3.1%
1/32
|
3.4%
1/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Peptic ulcer perforation
|
3.4%
1/29
|
0.00%
0/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Surgical and medical procedures
Spinal decompression
|
3.4%
1/29
|
0.00%
0/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/29
|
3.1%
1/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
1/29
|
0.00%
0/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
1/29
|
0.00%
0/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
Other adverse events
| Measure |
Cohort 1: Placebo
n=29 participants at risk
Participants received placebo tablets once daily
|
Cohort 1: Apixaban, 5 mg
n=32 participants at risk
Participants received apixaban as tablet, 5 mg, once daily
|
Cohort 1: Apixaban, 10 mg
n=29 participants at risk
Participants received apixaban as tablet, 10 mg, once daily
|
Cohort 1: Apixaban, 20 mg
n=32 participants at risk
Participants received apixaban as tablet, 20 mg, once daily
|
Cohort 2: Placebo
n=2 participants at risk
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 : Apixaban, 5 mg
n=3 participants at risk
: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.
|
|---|---|---|---|---|---|---|
|
Psychiatric disorders
Anxiety
|
3.4%
1/29
|
9.4%
3/32
|
0.00%
0/29
|
3.1%
1/32
|
0.00%
0/2
|
0.00%
0/3
|
|
General disorders
Chest pain
|
0.00%
0/29
|
3.1%
1/32
|
6.9%
2/29
|
3.1%
1/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Dry mouth
|
6.9%
2/29
|
9.4%
3/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.4%
1/29
|
3.1%
1/32
|
0.00%
0/29
|
12.5%
4/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/29
|
0.00%
0/32
|
6.9%
2/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
General disorders
Fatigue
|
6.9%
2/29
|
6.2%
2/32
|
3.4%
1/29
|
21.9%
7/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/29
|
9.4%
3/32
|
3.4%
1/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.4%
1/29
|
6.2%
2/32
|
3.4%
1/29
|
6.2%
2/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.9%
2/29
|
9.4%
3/32
|
17.2%
5/29
|
12.5%
4/32
|
50.0%
1/2
|
33.3%
1/3
|
|
Infections and infestations
Pneumonia
|
6.9%
2/29
|
0.00%
0/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/29
|
3.1%
1/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
33.3%
1/3
|
|
Eye disorders
Visual impairment
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
33.3%
1/3
|
|
Gastrointestinal disorders
Abdominal pain
|
3.4%
1/29
|
6.2%
2/32
|
0.00%
0/29
|
0.00%
0/32
|
50.0%
1/2
|
33.3%
1/3
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/29
|
6.2%
2/32
|
0.00%
0/2
|
33.3%
1/3
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/29
|
12.5%
4/32
|
20.7%
6/29
|
21.9%
7/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/29
|
3.1%
1/32
|
0.00%
0/29
|
6.2%
2/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Constipation
|
17.2%
5/29
|
15.6%
5/32
|
6.9%
2/29
|
15.6%
5/32
|
50.0%
1/2
|
33.3%
1/3
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/29
|
6.2%
2/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.9%
2/29
|
6.2%
2/32
|
10.3%
3/29
|
9.4%
3/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Nervous system disorders
Neuropathy peripheral
|
3.4%
1/29
|
0.00%
0/32
|
10.3%
3/29
|
3.1%
1/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Nervous system disorders
Paraesthesia
|
17.2%
5/29
|
3.1%
1/32
|
6.9%
2/29
|
9.4%
3/32
|
0.00%
0/2
|
33.3%
1/3
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/29
|
3.1%
1/32
|
50.0%
1/2
|
0.00%
0/3
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/29
|
0.00%
0/32
|
6.9%
2/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.4%
1/29
|
12.5%
4/32
|
10.3%
3/29
|
3.1%
1/32
|
0.00%
0/2
|
33.3%
1/3
|
|
Investigations
Blood glucose increased
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/29
|
3.1%
1/32
|
0.00%
0/2
|
33.3%
1/3
|
|
General disorders
Chills
|
0.00%
0/29
|
0.00%
0/32
|
3.4%
1/29
|
3.1%
1/32
|
0.00%
0/2
|
33.3%
1/3
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
13.8%
4/29
|
25.0%
8/32
|
13.8%
4/29
|
21.9%
7/32
|
50.0%
1/2
|
66.7%
2/3
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/29
|
6.2%
2/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Nausea
|
3.4%
1/29
|
9.4%
3/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.4%
1/29
|
6.2%
2/32
|
6.9%
2/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
33.3%
1/3
|
|
Renal and urinary disorders
Pollakiuria
|
6.9%
2/29
|
3.1%
1/32
|
3.4%
1/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/29
|
6.2%
2/32
|
3.4%
1/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Investigations
Weight increased
|
0.00%
0/29
|
6.2%
2/32
|
3.4%
1/29
|
3.1%
1/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/29
|
3.1%
1/32
|
6.9%
2/29
|
6.2%
2/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
33.3%
1/3
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
33.3%
1/3
|
|
Investigations
Blood potassium decreased
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
33.3%
1/3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.9%
2/29
|
3.1%
1/32
|
6.9%
2/29
|
3.1%
1/32
|
50.0%
1/2
|
33.3%
1/3
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/29
|
0.00%
0/32
|
3.4%
1/29
|
0.00%
0/32
|
0.00%
0/2
|
33.3%
1/3
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/29
|
9.4%
3/32
|
0.00%
0/29
|
6.2%
2/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/29
|
0.00%
0/32
|
50.0%
1/2
|
0.00%
0/3
|
|
General disorders
Pyrexia
|
6.9%
2/29
|
12.5%
4/32
|
6.9%
2/29
|
9.4%
3/32
|
0.00%
0/2
|
33.3%
1/3
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/29
|
0.00%
0/32
|
50.0%
1/2
|
0.00%
0/3
|
|
Investigations
Weight decreased
|
6.9%
2/29
|
6.2%
2/32
|
6.9%
2/29
|
6.2%
2/32
|
0.00%
0/2
|
33.3%
1/3
|
|
Skin and subcutaneous tissue disorders
Acne
|
6.9%
2/29
|
3.1%
1/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Anorexia
|
6.9%
2/29
|
0.00%
0/32
|
0.00%
0/29
|
3.1%
1/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/29
|
0.00%
0/32
|
50.0%
1/2
|
0.00%
0/3
|
|
Nervous system disorders
Dysgeusia
|
3.4%
1/29
|
6.2%
2/32
|
0.00%
0/29
|
3.1%
1/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.8%
4/29
|
9.4%
3/32
|
6.9%
2/29
|
9.4%
3/32
|
0.00%
0/2
|
0.00%
0/3
|
|
General disorders
Early satiety
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
33.3%
1/3
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/29
|
0.00%
0/32
|
6.9%
2/29
|
3.1%
1/32
|
0.00%
0/2
|
0.00%
0/3
|
|
General disorders
Oedema peripheral
|
10.3%
3/29
|
6.2%
2/32
|
6.9%
2/29
|
6.2%
2/32
|
0.00%
0/2
|
0.00%
0/3
|
|
General disorders
Asthenia
|
6.9%
2/29
|
0.00%
0/32
|
0.00%
0/29
|
3.1%
1/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/29
|
3.1%
1/32
|
10.3%
3/29
|
0.00%
0/32
|
50.0%
1/2
|
0.00%
0/3
|
|
Vascular disorders
Deep vein thrombosis
|
6.9%
2/29
|
0.00%
0/32
|
3.4%
1/29
|
3.1%
1/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Nervous system disorders
Dizziness
|
3.4%
1/29
|
9.4%
3/32
|
3.4%
1/29
|
6.2%
2/32
|
0.00%
0/2
|
0.00%
0/3
|
|
General disorders
Gait disturbance
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
33.3%
1/3
|
|
Nervous system disorders
Headache
|
10.3%
3/29
|
3.1%
1/32
|
3.4%
1/29
|
6.2%
2/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Nervous system disorders
Hypoaesthesia
|
6.9%
2/29
|
9.4%
3/32
|
6.9%
2/29
|
0.00%
0/32
|
0.00%
0/2
|
33.3%
1/3
|
|
General disorders
Mucosal inflammation
|
0.00%
0/29
|
6.2%
2/32
|
3.4%
1/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
33.3%
1/3
|
|
General disorders
Pain
|
3.4%
1/29
|
0.00%
0/32
|
3.4%
1/29
|
6.2%
2/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/29
|
9.4%
3/32
|
3.4%
1/29
|
6.2%
2/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/29
|
3.1%
1/32
|
50.0%
1/2
|
0.00%
0/3
|
|
Infections and infestations
Sinusitis
|
6.9%
2/29
|
3.1%
1/32
|
3.4%
1/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Infections and infestations
Upper respiratory tract infection
|
3.4%
1/29
|
0.00%
0/32
|
10.3%
3/29
|
12.5%
4/32
|
50.0%
1/2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/29
|
3.1%
1/32
|
3.4%
1/29
|
3.1%
1/32
|
0.00%
0/2
|
33.3%
1/3
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.4%
1/29
|
0.00%
0/32
|
6.9%
2/29
|
6.2%
2/32
|
50.0%
1/2
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.4%
1/29
|
0.00%
0/32
|
6.9%
2/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.4%
1/29
|
9.4%
3/32
|
17.2%
5/29
|
6.2%
2/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/29
|
3.1%
1/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
33.3%
1/3
|
|
Investigations
White blood cell count decreased
|
3.4%
1/29
|
3.1%
1/32
|
3.4%
1/29
|
6.2%
2/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
33.3%
1/3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.9%
2/29
|
3.1%
1/32
|
3.4%
1/29
|
3.1%
1/32
|
0.00%
0/2
|
0.00%
0/3
|
|
General disorders
Chest discomfort
|
0.00%
0/29
|
6.2%
2/32
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Psychiatric disorders
Depression
|
3.4%
1/29
|
3.1%
1/32
|
3.4%
1/29
|
3.1%
1/32
|
50.0%
1/2
|
33.3%
1/3
|
|
Gastrointestinal disorders
Diarrhoea
|
13.8%
4/29
|
15.6%
5/32
|
24.1%
7/29
|
31.2%
10/32
|
100.0%
2/2
|
33.3%
1/3
|
|
Gastrointestinal disorders
Dyspepsia
|
3.4%
1/29
|
9.4%
3/32
|
3.4%
1/29
|
6.2%
2/32
|
50.0%
1/2
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/29
|
0.00%
0/32
|
0.00%
0/29
|
0.00%
0/32
|
50.0%
1/2
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/29
|
6.2%
2/32
|
3.4%
1/29
|
6.2%
2/32
|
0.00%
0/2
|
0.00%
0/3
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/29
|
0.00%
0/32
|
3.4%
1/29
|
3.1%
1/32
|
0.00%
0/2
|
33.3%
1/3
|
|
Psychiatric disorders
Insomnia
|
10.3%
3/29
|
6.2%
2/32
|
3.4%
1/29
|
6.2%
2/32
|
100.0%
2/2
|
33.3%
1/3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.9%
2/29
|
6.2%
2/32
|
10.3%
3/29
|
3.1%
1/32
|
0.00%
0/2
|
33.3%
1/3
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/29
|
6.2%
2/32
|
3.4%
1/29
|
0.00%
0/32
|
50.0%
1/2
|
0.00%
0/3
|
|
Eye disorders
Vision blurred
|
0.00%
0/29
|
6.2%
2/32
|
3.4%
1/29
|
3.1%
1/32
|
0.00%
0/2
|
0.00%
0/3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER