Study: NCT01351805

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 170 affected / 6463 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 77 affected / 6463 at risk

Adverse event: Invasive cancer of any type
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Total cancer = invasive cancer of any type
Frequency: 408 affected / 6463 at risk

Adverse event: Death from cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 75 affected / 6463 at risk

Adverse event: Breast cancer (in women)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 60 affected / 6463 at risk

Adverse event: Prostate cancer (in men)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 109 affected / 6463 at risk

Adverse event: Colorectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 28 affected / 6463 at risk

Adverse event: Major cardiovascular event
Serious: yes
Organ System: Vascular disorders
Notes: Major cardiovascular event = a composite endpoint of myocardial infarction, stroke, and death from cardiovascular causes
Frequency: 186 affected / 6463 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Vascular disorders
Frequency: 72 affected / 6463 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 66 affected / 6463 at risk

Adverse event: Death from cardiovascular causes
Serious: yes
Organ System: Vascular disorders
Frequency: 74 affected / 6463 at risk

Adverse event: Easy bruising
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1737 affected / 6463 at risk

Adverse event: Frequent nosebleeds
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 224 affected / 6463 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 469 affected / 6463 at risk

Adverse event: Parathyroid condition
Serious: no
Organ System: Endocrine disorders
Notes: Parathyroid condition = hyperparathyroidism or hypoparathyroidism
Frequency: 24 affected / 6463 at risk

Adverse event: Stomach upset or pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2439 affected / 6463 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1748 affected / 6463 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2567 affected / 6463 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2781 affected / 6463 at risk

Adverse event: Increased burping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1107 affected / 6463 at risk

Adverse event: Bad taste in mouth
Serious: no
Organ System: General disorders
Frequency: 1109 affected / 6463 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 233 affected / 6463 at risk

Adverse event: Kidney failure or dialysis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 42 affected / 6463 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1629 affected / 6463 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 171 affected / 6464 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 70 affected / 6464 at risk

Adverse event: Invasive cancer of any type
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Total cancer = invasive cancer of any type
Frequency: 385 affected / 6464 at risk

Adverse event: Death from cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 79 affected / 6464 at risk

Adverse event: Breast cancer (in women)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 64 affected / 6464 at risk

Adverse event: Prostate cancer (in men)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 83 affected / 6464 at risk

Adverse event: Colorectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 23 affected / 6464 at risk

Adverse event: Major cardiovascular event
Serious: yes
Organ System: Vascular disorders
Notes: Major cardiovascular event = a composite endpoint of myocardial infarction, stroke, and death from cardiovascular causes
Frequency: 210 affected / 6464 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Vascular disorders
Frequency: 97 affected / 6464 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 75 affected / 6464 at risk

Adverse event: Death from cardiovascular causes
Serious: yes
Organ System: Vascular disorders
Frequency: 78 affected / 6464 at risk

Adverse event: Easy bruising
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1697 affected / 6464 at risk

Adverse event: Frequent nosebleeds
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 242 affected / 6464 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 442 affected / 6464 at risk

Adverse event: Parathyroid condition
Serious: no
Organ System: Endocrine disorders
Notes: Parathyroid condition = hyperparathyroidism or hypoparathyroidism
Frequency: 26 affected / 6464 at risk

Adverse event: Stomach upset or pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2421 affected / 6464 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1771 affected / 6464 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2566 affected / 6464 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2730 affected / 6464 at risk

Adverse event: Increased burping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1061 affected / 6464 at risk

Adverse event: Bad taste in mouth
Serious: no
Organ System: General disorders
Frequency: 1086 affected / 6464 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 244 affected / 6464 at risk

Adverse event: Kidney failure or dialysis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 43 affected / 6464 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1639 affected / 6464 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 200 affected / 6470 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 74 affected / 6470 at risk

Adverse event: Invasive cancer of any type
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Total cancer = invasive cancer of any type
Frequency: 412 affected / 6470 at risk

Adverse event: Death from cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 93 affected / 6470 at risk

Adverse event: Breast cancer (in women)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 57 affected / 6470 at risk

Adverse event: Prostate cancer (in men)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 110 affected / 6470 at risk

Adverse event: Colorectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 26 affected / 6470 at risk

Adverse event: Major cardiovascular event
Serious: yes
Organ System: Vascular disorders
Notes: Major cardiovascular event = a composite endpoint of myocardial infarction, stroke, and death from cardiovascular causes
Frequency: 200 affected / 6470 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Vascular disorders
Frequency: 73 affected / 6470 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 82 affected / 6470 at risk

Adverse event: Death from cardiovascular causes
Serious: yes
Organ System: Vascular disorders
Frequency: 68 affected / 6470 at risk

Adverse event: Easy bruising
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1706 affected / 6470 at risk

Adverse event: Frequent nosebleeds
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 241 affected / 6470 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 450 affected / 6470 at risk

Adverse event: Parathyroid condition
Serious: no
Organ System: Endocrine disorders
Notes: Parathyroid condition = hyperparathyroidism or hypoparathyroidism
Frequency: 28 affected / 6470 at risk

Adverse event: Stomach upset or pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2448 affected / 6470 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1810 affected / 6470 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2617 affected / 6470 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2818 affected / 6470 at risk

Adverse event: Increased burping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1110 affected / 6470 at risk

Adverse event: Bad taste in mouth
Serious: no
Organ System: General disorders
Frequency: 1131 affected / 6470 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 197 affected / 6470 at risk

Adverse event: Kidney failure or dialysis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 43 affected / 6470 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1702 affected / 6470 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 203 affected / 6474 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 69 affected / 6474 at risk

Adverse event: Invasive cancer of any type
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Total cancer = invasive cancer of any type
Frequency: 412 affected / 6474 at risk

Adverse event: Death from cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 94 affected / 6474 at risk

Adverse event: Breast cancer (in women)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 65 affected / 6474 at risk

Adverse event: Prostate cancer (in men)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 109 affected / 6474 at risk

Adverse event: Colorectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 21 affected / 6474 at risk

Adverse event: Major cardiovascular event
Serious: yes
Organ System: Vascular disorders
Notes: Major cardiovascular event = a composite endpoint of myocardial infarction, stroke, and death from cardiovascular causes
Frequency: 209 affected / 6474 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Vascular disorders
Frequency: 103 affected / 6474 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 67 affected / 6474 at risk

Adverse event: Death from cardiovascular causes
Serious: yes
Organ System: Vascular disorders
Frequency: 70 affected / 6474 at risk

Adverse event: Easy bruising
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1702 affected / 6474 at risk

Adverse event: Frequent nosebleeds
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 249 affected / 6474 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 432 affected / 6474 at risk

Adverse event: Parathyroid condition
Serious: no
Organ System: Endocrine disorders
Notes: Parathyroid condition = hyperparathyroidism or hypoparathyroidism
Frequency: 34 affected / 6474 at risk

Adverse event: Stomach upset or pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2422 affected / 6474 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1779 affected / 6474 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2545 affected / 6474 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2850 affected / 6474 at risk

Adverse event: Increased burping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1097 affected / 6474 at risk

Adverse event: Bad taste in mouth
Serious: no
Organ System: General disorders
Frequency: 1159 affected / 6474 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 229 affected / 6474 at risk

Adverse event: Kidney failure or dialysis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 45 affected / 6474 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1728 affected / 6474 at risk