Study: NCT01991795

Adverse event: Seronegative arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Sjogren's syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 9531 at risk

Adverse event: Spinal ligament ossification
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Spinal osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 9531 at risk

Adverse event: Spinal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Spondylitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Spondylolisthesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Tenosynovitis stenosans
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Acute myeloid leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 9531 at risk

Adverse event: Adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Adenocarcinoma gastric
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Adenocarcinoma of colon
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 9531 at risk

Adverse event: Adrenal adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Adrenal neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Anal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: B-cell lymphoma stage I
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 9 affected / 9531 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 9 affected / 9531 at risk

Adverse event: Bladder cancer recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Bladder neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 9531 at risk

Adverse event: Bladder transitional cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 9531 at risk

Adverse event: Bone cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Bowen's disease
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Brain neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Brain neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Breast cancer female
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 9531 at risk

Adverse event: Breast cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 9531 at risk

Adverse event: Breast neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Bronchial carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 9531 at risk

Adverse event: Cerebellopontine angle tumour
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Cervix carcinoma recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Cholangiocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Chordoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Chronic lymphocytic leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 9531 at risk

Adverse event: Chronic myeloid leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Clear cell renal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Colorectal adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 9531 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 16 affected / 9531 at risk

Adverse event: Colon cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 9531 at risk

Adverse event: Colon neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 9531 at risk

Adverse event: Colorectal adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Colorectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 9531 at risk

Adverse event: Cutaneous lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Endometrial cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Endometrial cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Endometrial cancer stage II
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Fibroadenoma of breast
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Fibrosarcoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Fibrous histiocytoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Gallbladder adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Gallbladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Gallbladder neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 9531 at risk

Adverse event: Gastric adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Gastric cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 10 affected / 9531 at risk

Adverse event: Gastric neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Gastrointestinal carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 9531 at risk

Adverse event: Gastrointestinal lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Gastrointestinal melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Gastrointestinal neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Gastrointestinal stromal tumour
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Glioblastoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Hepatic cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 9531 at risk

Adverse event: Hepatic cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Hepatobiliary neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Hepatocellular carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 9531 at risk

Adverse event: Invasive ductal breast carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Large intestine benign neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Lip and/or oral cavity cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 9531 at risk

Adverse event: Lip neoplasm malignant stage unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Lipoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Lung adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 9531 at risk

Adverse event: Lung cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 9531 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 20 affected / 9531 at risk

Adverse event: Lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 9531 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 9531 at risk

Adverse event: Meningioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Metastases to bone
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Metastases to central nervous system
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Metastases to liver
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Metastases to peritoneum
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Metastases to pleura
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Metastatic gastric cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Metastatic malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Metastatic neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Muscle neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Musculoskeletal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Myelodysplastic syndrome
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 9531 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 9531 at risk

Adverse event: Non-Hodgkin's lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Non-small cell lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 9531 at risk

Adverse event: Oesophageal adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Oesophageal carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 9531 at risk

Adverse event: Oral neoplasm benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Ovarian cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 9531 at risk

Adverse event: Ovarian fibroma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Ovarian granulosa cell tumour
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 12 affected / 9531 at risk

Adverse event: Pancreatic carcinoma metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Pancreatic neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 9531 at risk

Adverse event: Pancreatic neuroendocrine tumour
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Pancreatic sarcoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Papillary thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Parathyroid tumour benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Penis carcinoma metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Plasma cell myeloma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 9531 at risk

Adverse event: Plasmacytoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Pleural neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 36 affected / 9531 at risk

Adverse event: Prostate cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 9531 at risk

Adverse event: Prostate cancer recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 9531 at risk

Adverse event: Prostate cancer stage III
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Rectal adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 9531 at risk

Adverse event: Rectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 9531 at risk

Adverse event: Rectal cancer recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Rectosigmoid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Rectosigmoid cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Renal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 7 affected / 9531 at risk

Adverse event: Renal cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Renal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 9531 at risk

Adverse event: Renal neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 9531 at risk

Adverse event: Retroperitoneal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Skin cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 9531 at risk

Adverse event: Small cell lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Small intestine carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Squamous cell carcinoma of lung
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 9531 at risk

Adverse event: Squamous cell carcinoma of skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Squamous cell carcinoma of the oral cavity
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Squamous cell carcinoma of the tongue
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Thyroid adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 9531 at risk

Adverse event: Tongue neoplasm malignant stage unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Tonsil cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Transitional cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Tumour haemorrhage
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9531 at risk

Adverse event: Ageusia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Balance disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Basal ganglia infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 9531 at risk

Adverse event: Brain stem infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 9531 at risk

Adverse event: Carotid arteriosclerosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Carotid artery disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Carotid artery occlusion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 21 affected / 9531 at risk

Adverse event: Carpal tunnel syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 9531 at risk

Adverse event: Cauda equina syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Cerebellar haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Cerebellar stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Cerebral atrophy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Cerebral haematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 9531 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 27 affected / 9531 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 9531 at risk

Adverse event: Cerebral small vessel ischaemic disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 9531 at risk

Adverse event: Cerebrovascular insufficiency
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Cervical cord compression
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Cervical radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Cervicobrachial syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Dementia
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 9531 at risk

Adverse event: Diabetic neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 13 affected / 9531 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 12 affected / 9531 at risk

Adverse event: Embolic cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Embolic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 9531 at risk

Adverse event: Epileptic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Facial paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 9531 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 9531 at risk

Adverse event: Haemorrhagic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 9531 at risk

Adverse event: Haemorrhagic transformation stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 9531 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Hypoaesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Hypoglycaemic coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Hypoglycaemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Hypoglycaemic unconsciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: IIIrd nerve paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 9531 at risk

Adverse event: Intracranial aneurysm
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Intracranial pressure increased
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Ischaemic cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 9531 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 119 affected / 9531 at risk

Adverse event: Lacunar infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 9531 at risk

Adverse event: Lacunar stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 9531 at risk

Adverse event: Lumbar radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Lumbosacral radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Metabolic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Miller Fisher syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Myelopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Normal pressure hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Parkinson's disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 9531 at risk

Adverse event: Parkinsonism
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 9531 at risk

Adverse event: Peripheral nerve lesion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Petit mal epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 9531 at risk

Adverse event: Pseudoradicular syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Putamen haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Sciatica
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 9531 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 9531 at risk

Adverse event: Spinal cord compression
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Spinal epidural haematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 9531 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 27 affected / 9531 at risk

Adverse event: Thalamic infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Thalamus haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Toxic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Transient global amnesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 33 affected / 9531 at risk

Adverse event: Tremor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: VIth nerve disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: VIth nerve paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: VIth nerve paresis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Vascular dementia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Vascular encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Vertebrobasilar insufficiency
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Vertigo CNS origin
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Device failure
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 9531 at risk

Adverse event: Device loosening
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 9531 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 9531 at risk

Adverse event: Device occlusion
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 9531 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 9531 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 9531 at risk

Adverse event: Delirium tremens
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 4 affected / 9531 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Mental disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Neuropsychological symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 39 affected / 9531 at risk

Adverse event: Bladder neck obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Bladder outlet obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Calculus bladder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 9531 at risk

Adverse event: Calculus urethral
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Calculus urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 9531 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 15 affected / 9531 at risk

Adverse event: Diabetic nephropathy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 9531 at risk

Adverse event: End stage renal disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 9531 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 13 affected / 9531 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 9531 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 21 affected / 9531 at risk

Adverse event: Nephropathy toxic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Nephrotic syndrome
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 9531 at risk

Adverse event: Perinephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Proteinuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Renal artery arteriosclerosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Renal artery occlusion
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Renal artery stenosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 15 affected / 9531 at risk

Adverse event: Renal haemorrhage
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 9531 at risk

Adverse event: Renal injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Renal mass
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Tubulointerstitial nephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Ureteric stenosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 13 affected / 9531 at risk

Adverse event: Urinary bladder polyp
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Urinary incontinence
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 9531 at risk

Adverse event: Urinary tract obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Acquired hydrocele
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Acquired phimosis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 21 affected / 9531 at risk

Adverse event: Cervix disorder
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Cystocele
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Endometrial hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Gynaecomastia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Prostatic fibrosis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Prostatic obstruction
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Prostatitis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 9531 at risk

Adverse event: Prostatomegaly
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Uterine polyp
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Uterine prolapse
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 9531 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 9531 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 9531 at risk

Adverse event: Bronchiectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Bronchitis chronic
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Choking
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 41 affected / 9531 at risk

Adverse event: Chronic respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 29 affected / 9531 at risk

Adverse event: Dyspnoea exertional
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 9531 at risk

Adverse event: Emphysema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 9531 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 9531 at risk

Adverse event: Lung disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Lung infiltration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Nasal polyps
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Nasal septum deviation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Orthopnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Paranasal cyst
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 9531 at risk

Adverse event: Pleurisy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Pneumothorax spontaneous
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Pulmonary arterial hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 9531 at risk

Adverse event: Pulmonary fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 9531 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 9531 at risk

Adverse event: Pulmonary sarcoidosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 9531 at risk

Adverse event: Restrictive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Decubitus ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 9531 at risk

Adverse event: Dermatitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Diabetic foot
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 9531 at risk

Adverse event: Diabetic foot
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Henoch-Schonlein purpura
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Intertrigo
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Ischaemic skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Lichen planus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Necrobiosis lipoidica diabeticorum
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Petechiae
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Psoriasis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Skin exfoliation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Skin necrosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 9531 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Accelerated hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 9531 at risk

Adverse event: Aortic arteriosclerosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 9531 at risk

Adverse event: Arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Arterial stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Arterial thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Arteriosclerosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Artery dissection
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Circulatory collapse
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 9531 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 9531 at risk

Adverse event: Diabetic vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 9531 at risk

Adverse event: Extremity necrosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 45 affected / 9531 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 23 affected / 9531 at risk

Adverse event: Hypertensive emergency
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 9531 at risk

Adverse event: Hypovolaemic shock
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Iliac artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Iliac artery embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 9531 at risk

Adverse event: Labile blood pressure
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Necrosis ischaemic
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Neurogenic shock
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 48 affected / 9531 at risk

Adverse event: Peripheral artery aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Peripheral artery occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Peripheral artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 9531 at risk

Adverse event: Peripheral artery thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 9531 at risk

Adverse event: Peripheral coldness
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Peripheral embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 18 affected / 9531 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 9531 at risk

Adverse event: Peripheral venous disease
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 9531 at risk

Adverse event: Rheumatoid vasculitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Shock
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Subclavian artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Giant cell arteritis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Thrombophlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Superficial vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Varicose vein
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Vascular compression
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 9531 at risk

Adverse event: Peripheral vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 9531 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 610 affected / 9531 at risk