Study: NCT02422745

Adverse event: Total cardiovascular event
Serious: yes
Organ System: Vascular disorders
Notes: This outcome was a composite of myocardial infarction, stroke, CVD death, CABG/PCI, unstable angina including hospitalization, carotid artery surgery, and peripheral artery surgery
Frequency: 410 affected / 10719 at risk

Adverse event: Major cardiovascular event plus CABG/PCI
Serious: yes
Organ System: Vascular disorders
Notes: This outcome was a composite of myocardial infarction, stroke, and CVD death. CABG/PCI, coronary artery bypass graft and percutaneous coronary intervention; CVD, cardiovascular disease.
Frequency: 362 affected / 10719 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Vascular disorders
Frequency: 88 affected / 10719 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 113 affected / 10719 at risk

Adverse event: Death from cardiovascular causes
Serious: yes
Organ System: Vascular disorders
Frequency: 76 affected / 10719 at risk

Adverse event: Coronary revascularization procedures
Serious: yes
Organ System: Vascular disorders
Frequency: 166 affected / 10719 at risk

Adverse event: Unstable angina requiring hospitalization
Serious: yes
Organ System: Vascular disorders
Frequency: 46 affected / 10719 at risk

Adverse event: Carotid artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 25 affected / 10719 at risk

Adverse event: Peripheral artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 17 affected / 10719 at risk

Adverse event: Major cardiovascular events
Serious: yes
Organ System: Vascular disorders
Notes: This outcome was a composite of myocardial infarction, stroke, and CVD death. CVD, cardiovascular disease.
Frequency: 255 affected / 10719 at risk

Adverse event: Invasive Cancer of any type
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 550 affected / 10719 at risk

Adverse event: Breast cancer (in women)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 99 affected / 10719 at risk

Adverse event: Prostate cancer (in men)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 113 affected / 10719 at risk

Adverse event: Colorectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 38 affected / 10719 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 49 affected / 10719 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 39 affected / 10719 at risk

Adverse event: Death from cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 116 affected / 10719 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 507 affected / 10719 at risk

Adverse event: Stomach upset or pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5119 affected / 10719 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3900 affected / 10719 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5077 affected / 10719 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5627 affected / 10719 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3520 affected / 10719 at risk

Adverse event: Skin discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2332 affected / 10719 at risk

Adverse event: Fatigue or drowsiness
Serious: no
Organ System: General disorders
Frequency: 6268 affected / 10719 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: Infections and infestations
Frequency: 3851 affected / 10719 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 4195 affected / 10719 at risk

Adverse event: Frequent nosebleeds
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 524 affected / 10719 at risk

Adverse event: Easy bruising
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3836 affected / 10719 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 904 affected / 10719 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 834 affected / 10719 at risk

Adverse event: Other headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 4010 affected / 10719 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 4269 affected / 10719 at risk

Adverse event: Unintentional Fall
Serious: no
Organ System: General disorders
Frequency: 6067 affected / 10719 at risk

Adverse event: Total cardiovascular event
Serious: yes
Organ System: Vascular disorders
Notes: This outcome was a composite of myocardial infarction, stroke, CVD death, CABG/PCI, unstable angina including hospitalization, carotid artery surgery, and peripheral artery surgery
Frequency: 456 affected / 10723 at risk

Adverse event: Major cardiovascular event plus CABG/PCI
Serious: yes
Organ System: Vascular disorders
Notes: This outcome was a composite of myocardial infarction, stroke, and CVD death. CABG/PCI, coronary artery bypass graft and percutaneous coronary intervention; CVD, cardiovascular disease.
Frequency: 403 affected / 10723 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Vascular disorders
Frequency: 101 affected / 10723 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 124 affected / 10723 at risk

Adverse event: Death from cardiovascular causes
Serious: yes
Organ System: Vascular disorders
Frequency: 104 affected / 10723 at risk

Adverse event: Coronary revascularization procedures
Serious: yes
Organ System: Vascular disorders
Frequency: 175 affected / 10723 at risk

Adverse event: Unstable angina requiring hospitalization
Serious: yes
Organ System: Vascular disorders
Frequency: 46 affected / 10723 at risk

Adverse event: Carotid artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 27 affected / 10723 at risk

Adverse event: Peripheral artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 19 affected / 10723 at risk

Adverse event: Major cardiovascular events
Serious: yes
Organ System: Vascular disorders
Notes: This outcome was a composite of myocardial infarction, stroke, and CVD death. CVD, cardiovascular disease.
Frequency: 304 affected / 10723 at risk

Adverse event: Invasive Cancer of any type
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 503 affected / 10723 at risk

Adverse event: Breast cancer (in women)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 81 affected / 10723 at risk

Adverse event: Prostate cancer (in men)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 93 affected / 10723 at risk

Adverse event: Colorectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 29 affected / 10723 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 58 affected / 10723 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 35 affected / 10723 at risk

Adverse event: Death from cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 109 affected / 10723 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 507 affected / 10723 at risk

Adverse event: Stomach upset or pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4984 affected / 10723 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3756 affected / 10723 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5143 affected / 10723 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5639 affected / 10723 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3476 affected / 10723 at risk

Adverse event: Skin discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2361 affected / 10723 at risk

Adverse event: Fatigue or drowsiness
Serious: no
Organ System: General disorders
Frequency: 6228 affected / 10723 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: Infections and infestations
Frequency: 4022 affected / 10723 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 4129 affected / 10723 at risk

Adverse event: Frequent nosebleeds
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 555 affected / 10723 at risk

Adverse event: Easy bruising
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3864 affected / 10723 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 863 affected / 10723 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 971 affected / 10723 at risk

Adverse event: Other headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 4176 affected / 10723 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 4231 affected / 10723 at risk

Adverse event: Unintentional Fall
Serious: no
Organ System: General disorders
Frequency: 6059 affected / 10723 at risk

Adverse event: Total cardiovascular event
Serious: yes
Organ System: Vascular disorders
Notes: This outcome was a composite of myocardial infarction, stroke, CVD death, CABG/PCI, unstable angina including hospitalization, carotid artery surgery, and peripheral artery surgery
Frequency: 429 affected / 10720 at risk

Adverse event: Major cardiovascular event plus CABG/PCI
Serious: yes
Organ System: Vascular disorders
Notes: This outcome was a composite of myocardial infarction, stroke, and CVD death. CABG/PCI, coronary artery bypass graft and percutaneous coronary intervention; CVD, cardiovascular disease.
Frequency: 381 affected / 10720 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Vascular disorders
Frequency: 96 affected / 10720 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 121 affected / 10720 at risk

Adverse event: Death from cardiovascular causes
Serious: yes
Organ System: Vascular disorders
Frequency: 84 affected / 10720 at risk

Adverse event: Coronary revascularization procedures
Serious: yes
Organ System: Vascular disorders
Frequency: 177 affected / 10720 at risk

Adverse event: Unstable angina requiring hospitalization
Serious: yes
Organ System: Vascular disorders
Frequency: 50 affected / 10720 at risk

Adverse event: Carotid artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 24 affected / 10720 at risk

Adverse event: Peripheral artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 16 affected / 10720 at risk

Adverse event: Major cardiovascular events
Serious: yes
Organ System: Vascular disorders
Notes: This outcome was a composite of myocardial infarction, stroke, and CVD death. CVD, cardiovascular disease.
Frequency: 274 affected / 10720 at risk

Adverse event: Invasive Cancer of any type
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 518 affected / 10720 at risk

Adverse event: Breast cancer (in women)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 93 affected / 10720 at risk

Adverse event: Prostate cancer (in men)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 93 affected / 10720 at risk

Adverse event: Colorectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 38 affected / 10720 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 41 affected / 10720 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 34 affected / 10720 at risk

Adverse event: Death from cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 116 affected / 10720 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 544 affected / 10720 at risk

Adverse event: Stomach upset or pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4943 affected / 10720 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3827 affected / 10720 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5126 affected / 10720 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5521 affected / 10720 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3425 affected / 10720 at risk

Adverse event: Skin discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2294 affected / 10720 at risk

Adverse event: Fatigue or drowsiness
Serious: no
Organ System: General disorders
Frequency: 6215 affected / 10720 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: Infections and infestations
Frequency: 3962 affected / 10720 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 4113 affected / 10720 at risk

Adverse event: Frequent nosebleeds
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 533 affected / 10720 at risk

Adverse event: Easy bruising
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3756 affected / 10720 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 876 affected / 10720 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 887 affected / 10720 at risk

Adverse event: Other headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 4065 affected / 10720 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 4206 affected / 10720 at risk

Adverse event: Unintentional Fall
Serious: no
Organ System: General disorders
Frequency: 6042 affected / 10720 at risk

Adverse event: Total cardiovascular event
Serious: yes
Organ System: Vascular disorders
Notes: This outcome was a composite of myocardial infarction, stroke, CVD death, CABG/PCI, unstable angina including hospitalization, carotid artery surgery, and peripheral artery surgery
Frequency: 437 affected / 10722 at risk

Adverse event: Major cardiovascular event plus CABG/PCI
Serious: yes
Organ System: Vascular disorders
Notes: This outcome was a composite of myocardial infarction, stroke, and CVD death. CABG/PCI, coronary artery bypass graft and percutaneous coronary intervention; CVD, cardiovascular disease.
Frequency: 384 affected / 10722 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Vascular disorders
Frequency: 93 affected / 10722 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 116 affected / 10722 at risk

Adverse event: Death from cardiovascular causes
Serious: yes
Organ System: Vascular disorders
Frequency: 96 affected / 10722 at risk

Adverse event: Coronary revascularization procedures
Serious: yes
Organ System: Vascular disorders
Frequency: 164 affected / 10722 at risk

Adverse event: Unstable angina requiring hospitalization
Serious: yes
Organ System: Vascular disorders
Frequency: 42 affected / 10722 at risk

Adverse event: Carotid artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 28 affected / 10722 at risk

Adverse event: Peripheral artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 20 affected / 10722 at risk

Adverse event: Major cardiovascular events
Serious: yes
Organ System: Vascular disorders
Notes: This outcome was a composite of myocardial infarction, stroke, and CVD death. CVD, cardiovascular disease.
Frequency: 285 affected / 10722 at risk

Adverse event: Invasive Cancer of any type
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 535 affected / 10722 at risk

Adverse event: Breast cancer (in women)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 87 affected / 10722 at risk

Adverse event: Prostate cancer (in men)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 113 affected / 10722 at risk

Adverse event: Colorectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 29 affected / 10722 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 66 affected / 10722 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 40 affected / 10722 at risk

Adverse event: Death from cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 109 affected / 10722 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 470 affected / 10722 at risk

Adverse event: Stomach upset or pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5160 affected / 10722 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3829 affected / 10722 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5094 affected / 10722 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5745 affected / 10722 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3571 affected / 10722 at risk

Adverse event: Skin discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2399 affected / 10722 at risk

Adverse event: Fatigue or drowsiness
Serious: no
Organ System: General disorders
Frequency: 6281 affected / 10722 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: Infections and infestations
Frequency: 3911 affected / 10722 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 4211 affected / 10722 at risk

Adverse event: Frequent nosebleeds
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 546 affected / 10722 at risk

Adverse event: Easy bruising
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3944 affected / 10722 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 891 affected / 10722 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 918 affected / 10722 at risk

Adverse event: Other headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 4121 affected / 10722 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 4294 affected / 10722 at risk

Adverse event: Unintentional Fall
Serious: no
Organ System: General disorders
Frequency: 6084 affected / 10722 at risk

Adverse event: Total cardiovascular event
Serious: yes
Organ System: Vascular disorders
Notes: This outcome was a composite of myocardial infarction, stroke, CVD death, CABG/PCI, unstable angina including hospitalization, carotid artery surgery, and peripheral artery surgery
Frequency: 206 affected / 5360 at risk

Adverse event: Major cardiovascular event plus CABG/PCI
Serious: yes
Organ System: Vascular disorders
Notes: This outcome was a composite of myocardial infarction, stroke, and CVD death. CABG/PCI, coronary artery bypass graft and percutaneous coronary intervention; CVD, cardiovascular disease.
Frequency: 180 affected / 5360 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Vascular disorders
Frequency: 47 affected / 5360 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 56 affected / 5360 at risk

Adverse event: Death from cardiovascular causes
Serious: yes
Organ System: Vascular disorders
Frequency: 37 affected / 5360 at risk

Adverse event: Coronary revascularization procedures
Serious: yes
Organ System: Vascular disorders
Frequency: 87 affected / 5360 at risk

Adverse event: Unstable angina requiring hospitalization
Serious: yes
Organ System: Vascular disorders
Frequency: 26 affected / 5360 at risk

Adverse event: Carotid artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 12 affected / 5360 at risk

Adverse event: Peripheral artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 5360 at risk

Adverse event: Major cardiovascular events
Serious: yes
Organ System: Vascular disorders
Notes: This outcome was a composite of myocardial infarction, stroke, and CVD death. CVD, cardiovascular disease.
Frequency: 127 affected / 5360 at risk

Adverse event: Invasive Cancer of any type
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 283 affected / 5360 at risk

Adverse event: Breast cancer (in women)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 54 affected / 5360 at risk

Adverse event: Prostate cancer (in men)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 54 affected / 5360 at risk

Adverse event: Colorectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 22 affected / 5360 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 18 affected / 5360 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 20 affected / 5360 at risk

Adverse event: Death from cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 58 affected / 5360 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 272 affected / 5360 at risk

Adverse event: Stomach upset or pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2516 affected / 5360 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1977 affected / 5360 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2564 affected / 5360 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2762 affected / 5360 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1685 affected / 5360 at risk

Adverse event: Skin discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1124 affected / 5360 at risk

Adverse event: Fatigue or drowsiness
Serious: no
Organ System: General disorders
Frequency: 3142 affected / 5360 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: Infections and infestations
Frequency: 1979 affected / 5360 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2075 affected / 5360 at risk

Adverse event: Frequent nosebleeds
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 258 affected / 5360 at risk

Adverse event: Easy bruising
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1879 affected / 5360 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 446 affected / 5360 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 409 affected / 5360 at risk

Adverse event: Other headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 2007 affected / 5360 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2126 affected / 5360 at risk

Adverse event: Unintentional Fall
Serious: no
Organ System: General disorders
Frequency: 3048 affected / 5360 at risk

Adverse event: Total cardiovascular event
Serious: yes
Organ System: Vascular disorders
Notes: This outcome was a composite of myocardial infarction, stroke, CVD death, CABG/PCI, unstable angina including hospitalization, carotid artery surgery, and peripheral artery surgery
Frequency: 204 affected / 5359 at risk

Adverse event: Major cardiovascular event plus CABG/PCI
Serious: yes
Organ System: Vascular disorders
Notes: This outcome was a composite of myocardial infarction, stroke, and CVD death. CABG/PCI, coronary artery bypass graft and percutaneous coronary intervention; CVD, cardiovascular disease.
Frequency: 182 affected / 5359 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Vascular disorders
Frequency: 41 affected / 5359 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 57 affected / 5359 at risk

Adverse event: Death from cardiovascular causes
Serious: yes
Organ System: Vascular disorders
Frequency: 39 affected / 5359 at risk

Adverse event: Coronary revascularization procedures
Serious: yes
Organ System: Vascular disorders
Frequency: 79 affected / 5359 at risk

Adverse event: Unstable angina requiring hospitalization
Serious: yes
Organ System: Vascular disorders
Frequency: 20 affected / 5359 at risk

Adverse event: Carotid artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 13 affected / 5359 at risk

Adverse event: Peripheral artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 5359 at risk

Adverse event: Major cardiovascular events
Serious: yes
Organ System: Vascular disorders
Notes: This outcome was a composite of myocardial infarction, stroke, and CVD death. CVD, cardiovascular disease.
Frequency: 128 affected / 5359 at risk

Adverse event: Invasive Cancer of any type
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 267 affected / 5359 at risk

Adverse event: Breast cancer (in women)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 45 affected / 5359 at risk

Adverse event: Prostate cancer (in men)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 59 affected / 5359 at risk

Adverse event: Colorectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 16 affected / 5359 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 31 affected / 5359 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 19 affected / 5359 at risk

Adverse event: Death from cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 58 affected / 5359 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 235 affected / 5359 at risk

Adverse event: Stomach upset or pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2603 affected / 5359 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1923 affected / 5359 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2513 affected / 5359 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2865 affected / 5359 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1835 affected / 5359 at risk

Adverse event: Skin discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1208 affected / 5359 at risk

Adverse event: Fatigue or drowsiness
Serious: no
Organ System: General disorders
Frequency: 3126 affected / 5359 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: Infections and infestations
Frequency: 1872 affected / 5359 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2120 affected / 5359 at risk

Adverse event: Frequent nosebleeds
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 266 affected / 5359 at risk

Adverse event: Easy bruising
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1957 affected / 5359 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 458 affected / 5359 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 425 affected / 5359 at risk

Adverse event: Other headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 2003 affected / 5359 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2143 affected / 5359 at risk

Adverse event: Unintentional Fall
Serious: no
Organ System: General disorders
Frequency: 3019 affected / 5359 at risk

Adverse event: Total cardiovascular event
Serious: yes
Organ System: Vascular disorders
Notes: This outcome was a composite of myocardial infarction, stroke, CVD death, CABG/PCI, unstable angina including hospitalization, carotid artery surgery, and peripheral artery surgery
Frequency: 223 affected / 5360 at risk

Adverse event: Major cardiovascular event plus CABG/PCI
Serious: yes
Organ System: Vascular disorders
Notes: This outcome was a composite of myocardial infarction, stroke, and CVD death. CABG/PCI, coronary artery bypass graft and percutaneous coronary intervention; CVD, cardiovascular disease.
Frequency: 201 affected / 5360 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Vascular disorders
Frequency: 49 affected / 5360 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 65 affected / 5360 at risk

Adverse event: Death from cardiovascular causes
Serious: yes
Organ System: Vascular disorders
Frequency: 47 affected / 5360 at risk

Adverse event: Coronary revascularization procedures
Serious: yes
Organ System: Vascular disorders
Frequency: 90 affected / 5360 at risk

Adverse event: Unstable angina requiring hospitalization
Serious: yes
Organ System: Vascular disorders
Frequency: 24 affected / 5360 at risk

Adverse event: Carotid artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 12 affected / 5360 at risk

Adverse event: Peripheral artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 5360 at risk

Adverse event: Major cardiovascular events
Serious: yes
Organ System: Vascular disorders
Notes: This outcome was a composite of myocardial infarction, stroke, and CVD death. CVD, cardiovascular disease.
Frequency: 147 affected / 5360 at risk

Adverse event: Invasive Cancer of any type
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 235 affected / 5360 at risk

Adverse event: Breast cancer (in women)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 39 affected / 5360 at risk

Adverse event: Prostate cancer (in men)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 39 affected / 5360 at risk

Adverse event: Colorectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 16 affected / 5360 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 23 affected / 5360 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 14 affected / 5360 at risk

Adverse event: Death from cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 58 affected / 5360 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 272 affected / 5360 at risk

Adverse event: Stomach upset or pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2427 affected / 5360 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1850 affected / 5360 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2562 affected / 5360 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2759 affected / 5360 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1740 affected / 5360 at risk

Adverse event: Skin discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1170 affected / 5360 at risk

Adverse event: Fatigue or drowsiness
Serious: no
Organ System: General disorders
Frequency: 3073 affected / 5360 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: Infections and infestations
Frequency: 1983 affected / 5360 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2038 affected / 5360 at risk

Adverse event: Frequent nosebleeds
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 275 affected / 5360 at risk

Adverse event: Easy bruising
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1877 affected / 5360 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 430 affected / 5360 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 478 affected / 5360 at risk

Adverse event: Other headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 2058 affected / 5360 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2080 affected / 5360 at risk

Adverse event: Unintentional Fall
Serious: no
Organ System: General disorders
Frequency: 2994 affected / 5360 at risk

Adverse event: Total cardiovascular event
Serious: yes
Organ System: Vascular disorders
Notes: This outcome was a composite of myocardial infarction, stroke, CVD death, CABG/PCI, unstable angina including hospitalization, carotid artery surgery, and peripheral artery surgery
Frequency: 233 affected / 5363 at risk

Adverse event: Major cardiovascular event plus CABG/PCI
Serious: yes
Organ System: Vascular disorders
Notes: This outcome was a composite of myocardial infarction, stroke, and CVD death. CABG/PCI, coronary artery bypass graft and percutaneous coronary intervention; CVD, cardiovascular disease.
Frequency: 202 affected / 5363 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Vascular disorders
Frequency: 52 affected / 5363 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 59 affected / 5363 at risk

Adverse event: Death from cardiovascular causes
Serious: yes
Organ System: Vascular disorders
Frequency: 57 affected / 5363 at risk

Adverse event: Coronary revascularization procedures
Serious: yes
Organ System: Vascular disorders
Frequency: 85 affected / 5363 at risk

Adverse event: Unstable angina requiring hospitalization
Serious: yes
Organ System: Vascular disorders
Frequency: 22 affected / 5363 at risk

Adverse event: Carotid artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 15 affected / 5363 at risk

Adverse event: Peripheral artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 5363 at risk

Adverse event: Major cardiovascular events
Serious: yes
Organ System: Vascular disorders
Notes: This outcome was a composite of myocardial infarction, stroke, and CVD death. CVD, cardiovascular disease.
Frequency: 157 affected / 5363 at risk

Adverse event: Invasive Cancer of any type
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 268 affected / 5363 at risk

Adverse event: Breast cancer (in women)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 42 affected / 5363 at risk

Adverse event: Prostate cancer (in men)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 54 affected / 5363 at risk

Adverse event: Colorectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 13 affected / 5363 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 35 affected / 5363 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 21 affected / 5363 at risk

Adverse event: Death from cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 51 affected / 5363 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 235 affected / 5363 at risk

Adverse event: Stomach upset or pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2557 affected / 5363 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1906 affected / 5363 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2581 affected / 5363 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2880 affected / 5363 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1736 affected / 5363 at risk

Adverse event: Skin discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1191 affected / 5363 at risk

Adverse event: Fatigue or drowsiness
Serious: no
Organ System: General disorders
Frequency: 3155 affected / 5363 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: Infections and infestations
Frequency: 2039 affected / 5363 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2091 affected / 5363 at risk

Adverse event: Frequent nosebleeds
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 280 affected / 5363 at risk

Adverse event: Easy bruising
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1987 affected / 5363 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 433 affected / 5363 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 493 affected / 5363 at risk

Adverse event: Other headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 2118 affected / 5363 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2151 affected / 5363 at risk

Adverse event: Unintentional Fall
Serious: no
Organ System: General disorders
Frequency: 3065 affected / 5363 at risk