Serious adverse events
|
Dabigatran etexilate 110 or 150 milligram (mg) |
Acetylsalicylic acid, Aspirin (ASA) 100 mg |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
724 / 2676 (27.06%) |
740 / 2674 (27.67%) |
number of deaths (all causes)
|
56 |
58 |
number of deaths resulting from adverse events
|
1 |
2 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Adenocarcinoma of colon
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
3 / 2674 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenoma benign
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
B-cell lymphoma
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basal cell carcinoma
|
|
|
subjects affected / exposed
|
9 / 2676 (0.34%) |
12 / 2674 (0.45%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder cancer
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder cancer recurrent
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder neoplasm
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bowen's disease
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain neoplasm
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
3 / 2674 (0.11%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Brain neoplasm malignant
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer recurrent
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carcinoid tumour
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebellar haemangioma
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangiocarcinoma
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Clear cell renal cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon adenoma
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon cancer
|
|
|
subjects affected / exposed
|
8 / 2676 (0.30%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon cancer stage IV
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon neoplasm
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colorectal cancer
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal neoplasm
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial cancer
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Essential thrombocythaemia
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric adenoma
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric cancer
|
|
|
subjects affected / exposed
|
3 / 2676 (0.11%) |
3 / 2674 (0.11%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Glioblastoma multiforme
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hepatocellular carcinoma
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypopharyngeal cancer
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Invasive breast carcinoma
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal cancer
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal cancer stage 0
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lip and/or oral cavity cancer
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lung neoplasm
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung neoplasm malignant
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Malignant melanoma
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant melanoma in situ
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to liver
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to lung
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to lymph nodes
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastatic bronchial carcinoma
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metastatic malignant melanoma
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myelodysplastic syndrome
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myelofibrosis
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myeloproliferative neoplasm
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-Hodgkin's lymphoma
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal squamous cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian adenoma
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian epithelial cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Papillary thyroid cancer
|
|
|
subjects affected / exposed
|
3 / 2676 (0.11%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Plasma cell myeloma
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polycythaemia vera
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer
|
|
|
subjects affected / exposed
|
7 / 2676 (0.26%) |
6 / 2674 (0.22%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer recurrent
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatic adenoma
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal cancer
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cancer
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cell carcinoma recurrent
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin cancer
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestine carcinoma
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma
|
|
|
subjects affected / exposed
|
3 / 2676 (0.11%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of skin
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the vulva
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thymoma
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transitional cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tumour obstruction
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine leiomyoma
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
Aortic aneurysm
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic occlusion
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic stenosis
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriosclerosis
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteritis
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blue toe syndrome
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Circulatory collapse
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Deep vein thrombosis
|
|
|
subjects affected / exposed
|
4 / 2676 (0.15%) |
9 / 2674 (0.34%) |
occurrences causally related to treatment / all
|
0 / 4 |
1 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolism
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extremity necrosis
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertension
|
|
|
subjects affected / exposed
|
4 / 2676 (0.15%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive crisis
|
|
|
subjects affected / exposed
|
11 / 2676 (0.41%) |
4 / 2674 (0.15%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypotension
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iliac artery occlusion
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemia
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
3 / 2674 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orthostatic hypotension
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral arterial occlusive disease
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
4 / 2674 (0.15%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery occlusion
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
5 / 2674 (0.19%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery stenosis
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral ischaemia
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
3 / 2674 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shock haemorrhagic
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombophlebitis
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varicose vein
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vasospasm
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
Cardiac pacemaker insertion
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hysterectomy
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myomectomy
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tooth extraction
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
Asthenia
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest discomfort
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest pain
|
|
|
subjects affected / exposed
|
7 / 2676 (0.26%) |
5 / 2674 (0.19%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Death
|
|
|
subjects affected / exposed
|
3 / 2676 (0.11%) |
6 / 2674 (0.22%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 3 |
1 / 6 |
Fatigue
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Feeling cold
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gait disturbance
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General physical health deterioration
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ill-defined disorder
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incarcerated hernia
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inflammation
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malaise
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
3 / 2674 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Necrosis
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden cardiac death
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Sudden death
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Vascular stent stenosis
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
Anaphylactic reaction
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypersensitivity
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Social circumstances
|
|
|
Tanning
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
Acquired hydrocele
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Balanoposthitis
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign prostatic hyperplasia
|
|
|
subjects affected / exposed
|
5 / 2676 (0.19%) |
3 / 2674 (0.11%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast mass
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical dysplasia
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical polyp
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Menorrhagia
|
|
|
subjects affected / exposed
|
3 / 2676 (0.11%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
3 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatitis
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spermatocele
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine polyp
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine prolapse
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal haemorrhage
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal polyp
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
Alveolitis allergic
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asthma
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atelectasis
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis chronic
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchopneumopathy
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic obstructive pulmonary disease
|
|
|
subjects affected / exposed
|
6 / 2676 (0.22%) |
6 / 2674 (0.22%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Dyspnoea
|
|
|
subjects affected / exposed
|
8 / 2676 (0.30%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspnoea exertional
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Emphysema
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoxia
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Interstitial lung disease
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal oedema
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal polyps
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleurisy
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia aspiration
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pulmonary alveolar haemorrhage
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary congestion
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
7 / 2674 (0.26%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary fibrosis
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
3 / 2674 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary oedema
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory failure
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
4 / 2674 (0.15%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Sleep apnoea syndrome
|
|
|
subjects affected / exposed
|
3 / 2676 (0.11%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tachypnoea
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
Adjustment disorder
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aggression
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol withdrawal syndrome
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anxiety
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bipolar I disorder
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bipolar disorder
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Completed suicide
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Confusional state
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Delirium
|
|
|
subjects affected / exposed
|
5 / 2676 (0.19%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depression
|
|
|
subjects affected / exposed
|
7 / 2676 (0.26%) |
4 / 2674 (0.15%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Generalised anxiety disorder
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hallucination
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Major depression
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental status changes
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Panic attack
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post stroke depression
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Schizophrenia
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Somatic symptom disorder
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suicidal ideation
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
3 / 2674 (0.11%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Product issues
|
|
|
Device dislocation
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
Acute hepatic failure
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct obstruction
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct stone
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
3 / 2674 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis acute
|
|
|
subjects affected / exposed
|
3 / 2676 (0.11%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis chronic
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
subjects affected / exposed
|
4 / 2676 (0.15%) |
3 / 2674 (0.11%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic failure
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic function abnormal
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis acute
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperbilirubinaemia
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jaundice
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jaundice cholestatic
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigations
|
|
|
Alanine aminotransferase increased
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aspartate aminotransferase increased
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct pressure increased
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood creatinine increased
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood glucose increased
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood pressure increased
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Computerised tomogram thorax abnormal
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Creatinine renal clearance decreased
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrocardiogram Q waves
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gamma-glutamyltransferase increased
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemoglobin decreased
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza A virus test positive
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatic specific antigen increased
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
Acetabulum fracture
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Airway burns
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol poisoning
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ankle fracture
|
|
|
subjects affected / exposed
|
4 / 2676 (0.15%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial injury
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical vertebral fracture
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest injury
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clavicle fracture
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Concussion
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Contusion
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Exposure during pregnancy
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial bones fracture
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fall
|
|
|
subjects affected / exposed
|
21 / 2676 (0.78%) |
9 / 2674 (0.34%) |
occurrences causally related to treatment / all
|
0 / 22 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral neck fracture
|
|
|
subjects affected / exposed
|
3 / 2676 (0.11%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
subjects affected / exposed
|
3 / 2676 (0.11%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot fracture
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fracture
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fracture displacement
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hand fracture
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Head injury
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hip fracture
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Humerus fracture
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intentional overdose
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jaw fracture
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint dislocation
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint injury
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laceration
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
3 / 2674 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament rupture
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament sprain
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb injury
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
3 / 2674 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb traumatic amputation
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower limb fracture
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar vertebral fracture
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meniscus injury
|
|
|
subjects affected / exposed
|
4 / 2676 (0.15%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple fractures
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple injuries
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle strain
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Near drowning
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Overdose
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic fracture
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Poisoning deliberate
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative ileus
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pubis fracture
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary contusion
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radius fracture
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
4 / 2674 (0.15%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
subjects affected / exposed
|
4 / 2676 (0.15%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Road traffic accident
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scapula fracture
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skull fracture
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
subjects affected / exposed
|
3 / 2676 (0.11%) |
3 / 2674 (0.11%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal cord injury
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal cord injury cervical
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal fracture
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subarachnoid haemorrhage
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
4 / 2674 (0.15%) |
occurrences causally related to treatment / all
|
1 / 2 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subdural haematoma
|
|
|
subjects affected / exposed
|
7 / 2676 (0.26%) |
3 / 2674 (0.11%) |
occurrences causally related to treatment / all
|
5 / 7 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subdural haemorrhage
|
|
|
subjects affected / exposed
|
3 / 2676 (0.11%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
2 / 3 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tendon rupture
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thermal burn
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thoracic vertebral fracture
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tibia fracture
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic haemothorax
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic intracranial haemorrhage
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
1 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ulna fracture
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper limb fracture
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
3 / 2674 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wrist fracture
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
Atrial septal defect
|
|
|
subjects affected / exposed
|
3 / 2676 (0.11%) |
4 / 2674 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Corneal dystrophy
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cryopyrin associated periodic syndrome
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Factor V Leiden mutation
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heart disease congenital
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Phimosis
|
|
|
subjects affected / exposed
|
4 / 2676 (0.15%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular septal defect
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
Acute coronary syndrome
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute myocardial infarction
|
|
|
subjects affected / exposed
|
11 / 2676 (0.41%) |
8 / 2674 (0.30%) |
occurrences causally related to treatment / all
|
0 / 11 |
1 / 8 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
Angina pectoris
|
|
|
subjects affected / exposed
|
3 / 2676 (0.11%) |
4 / 2674 (0.15%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angina unstable
|
|
|
subjects affected / exposed
|
4 / 2676 (0.15%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve incompetence
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arrhythmia
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial fibrillation
|
|
|
subjects affected / exposed
|
24 / 2676 (0.90%) |
20 / 2674 (0.75%) |
occurrences causally related to treatment / all
|
0 / 24 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial flutter
|
|
|
subjects affected / exposed
|
10 / 2676 (0.37%) |
10 / 2674 (0.37%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial fibrillation or atrial flutter
|
|
|
subjects affected / exposed
|
34 / 2676 (1.27%) |
29 / 2674 (1.08%) |
occurrences causally related to treatment / all
|
0 / 34 |
0 / 30 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block second degree
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial tachycardia
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac arrest
|
|
|
subjects affected / exposed
|
3 / 2676 (0.11%) |
5 / 2674 (0.19%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
Cardiac disorder
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure
|
|
|
subjects affected / exposed
|
5 / 2676 (0.19%) |
10 / 2674 (0.37%) |
occurrences causally related to treatment / all
|
0 / 5 |
2 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure acute
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure chronic
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac ventricular thrombosis
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure congestive
|
|
|
subjects affected / exposed
|
4 / 2676 (0.15%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardio-respiratory arrest
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cardiomyopathy
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congestive cardiomyopathy
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery disease
|
|
|
subjects affected / exposed
|
6 / 2676 (0.22%) |
11 / 2674 (0.41%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery stenosis
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
3 / 2674 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocardial infarction
|
|
|
subjects affected / exposed
|
8 / 2676 (0.30%) |
8 / 2674 (0.30%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Myocardial ischaemia
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocarditis
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Palpitations
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prinzmetal angina
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Right ventricular failure
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinoatrial block
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus arrest
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus bradycardia
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus node dysfunction
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular extrasystoles
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular tachycardia
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
3 / 2674 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
Aphasia
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ataxia
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain injury
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain stem infarction
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain stem stroke
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid arteriosclerosis
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery aneurysm
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery stenosis
|
|
|
subjects affected / exposed
|
3 / 2676 (0.11%) |
3 / 2674 (0.11%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carpal tunnel syndrome
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Central pain syndrome
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebellar infarction
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
3 / 2674 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebellar stroke
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral cyst
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral haemorrhage
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral infarction
|
|
|
subjects affected / exposed
|
25 / 2676 (0.93%) |
42 / 2674 (1.57%) |
occurrences causally related to treatment / all
|
7 / 26 |
3 / 44 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cerebral ischaemia
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral vasoconstriction
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebrovascular accident
|
|
|
subjects affected / exposed
|
95 / 2676 (3.55%) |
97 / 2674 (3.63%) |
occurrences causally related to treatment / all
|
9 / 105 |
15 / 102 |
deaths causally related to treatment / all
|
0 / 1 |
1 / 3 |
Cervicobrachial syndrome
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervicogenic headache
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cubital tunnel syndrome
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dementia
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic neuropathy
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diplegia
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dizziness
|
|
|
subjects affected / exposed
|
8 / 2676 (0.30%) |
4 / 2674 (0.15%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dizziness postural
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolic cerebral infarction
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolic stroke
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Encephalopathy
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
subjects affected / exposed
|
18 / 2676 (0.67%) |
25 / 2674 (0.93%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 28 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial paralysis
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
3 / 2674 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial paresis
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Focal dyscognitive seizures
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Generalised tonic-clonic seizure
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Guillain-Barre syndrome
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage intracranial
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Haemorrhagic cerebral infarction
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic stroke
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic transformation stroke
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Headache
|
|
|
subjects affected / exposed
|
3 / 2676 (0.11%) |
3 / 2674 (0.11%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemianaesthesia
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemiparesis
|
|
|
subjects affected / exposed
|
5 / 2676 (0.19%) |
3 / 2674 (0.11%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive encephalopathy
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoaesthesia
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
4 / 2674 (0.15%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemic coma
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoxic-ischaemic encephalopathy
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intracranial aneurysm
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic cerebral infarction
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic stroke
|
|
|
subjects affected / exposed
|
47 / 2676 (1.76%) |
45 / 2674 (1.68%) |
occurrences causally related to treatment / all
|
9 / 48 |
5 / 47 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Lacunar infarction
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Loss of consciousness
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Memory impairment
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic encephalopathy
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Migraine
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Migraine with aura
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Monoparesis
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Monoplegia
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple sclerosis
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle spasticity
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuralgia
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuralgic amyotrophy
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neurodegenerative disorder
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuroglycopenia
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neurological symptom
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathy peripheral
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paraesthesia
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Partial seizures
|
|
|
subjects affected / exposed
|
5 / 2676 (0.19%) |
5 / 2674 (0.19%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polyneuropathy
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post stroke epilepsy
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post stroke seizure
|
|
|
subjects affected / exposed
|
3 / 2676 (0.11%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Presyncope
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudostroke
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radial nerve compression
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sciatica
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Seizure
|
|
|
subjects affected / exposed
|
17 / 2676 (0.64%) |
16 / 2674 (0.60%) |
occurrences causally related to treatment / all
|
1 / 21 |
0 / 23 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sensory disturbance
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sensory loss
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Status epilepticus
|
|
|
subjects affected / exposed
|
3 / 2676 (0.11%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Syncope
|
|
|
subjects affected / exposed
|
8 / 2676 (0.30%) |
6 / 2674 (0.22%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Temporal lobe epilepsy
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombotic cerebral infarction
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tonic convulsion
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transient global amnesia
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
subjects affected / exposed
|
46 / 2676 (1.72%) |
41 / 2674 (1.53%) |
occurrences causally related to treatment / all
|
3 / 50 |
3 / 45 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebrobasilar insufficiency
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Visual field defect
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vocal cord paralysis
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
Anaemia
|
|
|
subjects affected / exposed
|
7 / 2676 (0.26%) |
3 / 2674 (0.11%) |
occurrences causally related to treatment / all
|
4 / 7 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Disseminated intravascular coagulation
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Febrile neutropenia
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypochromic anaemia
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iron deficiency anaemia
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
Deafness
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Deafness neurosensory
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden hearing loss
|
|
|
subjects affected / exposed
|
6 / 2676 (0.22%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo
|
|
|
subjects affected / exposed
|
7 / 2676 (0.26%) |
8 / 2674 (0.30%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo positional
|
|
|
subjects affected / exposed
|
3 / 2676 (0.11%) |
3 / 2674 (0.11%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
Age-related macular degeneration
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Amaurosis
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Amaurosis fugax
|
|
|
subjects affected / exposed
|
3 / 2676 (0.11%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angle closure glaucoma
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blepharitis
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract
|
|
|
subjects affected / exposed
|
4 / 2676 (0.15%) |
7 / 2674 (0.26%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract nuclear
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dacryostenosis acquired
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic retinopathy
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye haemorrhage
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glaucoma
|
|
|
subjects affected / exposed
|
6 / 2676 (0.22%) |
6 / 2674 (0.22%) |
occurrences causally related to treatment / all
|
1 / 6 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Idiopathic orbital inflammation
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Macular degeneration
|
|
|
subjects affected / exposed
|
3 / 2676 (0.11%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Macular fibrosis
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Macular hole
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Narrow anterior chamber angle
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Optic atrophy
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Optic ischaemic neuropathy
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pterygium
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal artery occlusion
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal detachment
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal drusen
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal tear
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vision blurred
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Visual impairment
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitreous haemorrhage
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
Abdominal discomfort
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal hernia
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
subjects affected / exposed
|
3 / 2676 (0.11%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal fissure
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal fistula
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendix disorder
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis ischaemic
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis ulcerative
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Constipation
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocolitis
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erosive oesophagitis
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Faecaloma
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric haemorrhage
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
2 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric polyps
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
1 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer haemorrhage
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Gastritis
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
7 / 2676 (0.26%) |
5 / 2674 (0.19%) |
occurrences causally related to treatment / all
|
6 / 7 |
2 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal necrosis
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrooesophageal reflux disease
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematochezia
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoidal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoids
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hiatus hernia
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileal perforation
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Inguinal hernia
|
|
|
subjects affected / exposed
|
5 / 2676 (0.19%) |
3 / 2674 (0.11%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal ischaemia
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal obstruction
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
3 / 2674 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal perforation
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal polyp
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intra-abdominal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Irritable bowel syndrome
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic enteritis
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine perforation
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine polyp
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Melaena
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nausea
|
|
|
subjects affected / exposed
|
3 / 2676 (0.11%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis acute
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis chronic
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritoneal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal haemorrhage
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
2 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal perforation
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retroperitoneal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subileus
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
3 / 2674 (0.11%) |
occurrences causally related to treatment / all
|
1 / 1 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vomiting
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
Angioedema
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis atopic
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eczema
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage subcutaneous
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypersensitivity vasculitis
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nail disorder
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psoriasis
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Purpura
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin ulcer
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
Acute kidney injury
|
|
|
subjects affected / exposed
|
8 / 2676 (0.30%) |
10 / 2674 (0.37%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anuria
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus bladder
|
|
|
subjects affected / exposed
|
3 / 2676 (0.11%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus urinary
|
|
|
subjects affected / exposed
|
3 / 2676 (0.11%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic kidney disease
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic nephropathy
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glomerulonephritis proliferative
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematuria
|
|
|
subjects affected / exposed
|
6 / 2676 (0.22%) |
3 / 2674 (0.11%) |
occurrences causally related to treatment / all
|
6 / 6 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
subjects affected / exposed
|
6 / 2676 (0.22%) |
5 / 2674 (0.19%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pollakiuria
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postrenal failure
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal colic
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
3 / 2674 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal failure
|
|
|
subjects affected / exposed
|
4 / 2676 (0.15%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal impairment
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal ischaemia
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal mass
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal tubular necrosis
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureteric obstruction
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureterolithiasis
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
4 / 2674 (0.15%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral stenosis
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary retention
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract obstruction
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urogenital haemorrhage
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
Adrenal haematoma
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adrenal mass
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Goitre
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperthyroidism
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypothyroidism
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inappropriate antidiuretic hormone secretion
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxic nodular goitre
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
Arthralgia
|
|
|
subjects affected / exposed
|
3 / 2676 (0.11%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Back pain
|
|
|
subjects affected / exposed
|
3 / 2676 (0.11%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bursitis
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical spinal stenosis
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diffuse idiopathic skeletal hyperostosis
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot deformity
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fracture nonunion
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Groin pain
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemarthrosis
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc degeneration
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc disorder
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
subjects affected / exposed
|
3 / 2676 (0.11%) |
4 / 2674 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jaw cyst
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint stiffness
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb discomfort
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar spinal stenosis
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meniscal degeneration
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mobility decreased
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle haemorrhage
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscular weakness
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal chest pain
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal pain
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Necrotising myositis
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteitis
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
subjects affected / exposed
|
12 / 2676 (0.45%) |
19 / 2674 (0.71%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 21 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteonecrosis
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoporotic fracture
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polymyalgia rheumatica
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudarthrosis
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psoriatic arthropathy
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rhabdomyolysis
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rotator cuff syndrome
|
|
|
subjects affected / exposed
|
3 / 2676 (0.11%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal osteoarthritis
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Synovial cyst
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Systemic lupus erythematosus
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Systemic scleroderma
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
Appendiceal abscess
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis bacterial
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis bacterial
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
subjects affected / exposed
|
3 / 2676 (0.11%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Conjunctivitis
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dengue fever
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device related infection
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulitis intestinal haemorrhagic
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear infection
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocarditis
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epididymitis
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia sepsis
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gangrene
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
subjects affected / exposed
|
3 / 2676 (0.11%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis norovirus
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematoma infection
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes zoster
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infectious pleural effusion
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza
|
|
|
subjects affected / exposed
|
5 / 2676 (0.19%) |
4 / 2674 (0.15%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leptospirosis
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningitis bacterial
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mycotoxicosis
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuroborreliosis
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neurosyphilis
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orchitis
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Otitis media acute
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parotitis
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perineal abscess
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periodontitis
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perirectal abscess
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonitis
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonitis bacterial
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonsillar abscess
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
subjects affected / exposed
|
18 / 2676 (0.67%) |
14 / 2674 (0.52%) |
occurrences causally related to treatment / all
|
1 / 21 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
Pneumonia bacterial
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia viral
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative wound infection
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary sepsis
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulpitis dental
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis acute
|
|
|
subjects affected / exposed
|
3 / 2676 (0.11%) |
4 / 2674 (0.15%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
3 / 2674 (0.11%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Sepsis
|
|
|
subjects affected / exposed
|
5 / 2676 (0.19%) |
6 / 2674 (0.22%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Septic embolus
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Septic shock
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Sialoadenitis
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombophlebitis septic
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tuberculous pleurisy
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
subjects affected / exposed
|
13 / 2676 (0.49%) |
5 / 2674 (0.19%) |
occurrences causally related to treatment / all
|
2 / 14 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vestibular neuronitis
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
Dehydration
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes mellitus
|
|
|
subjects affected / exposed
|
3 / 2676 (0.11%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes mellitus inadequate control
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gout
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
3 / 2674 (0.11%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
subjects affected / exposed
|
2 / 2676 (0.07%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypovolaemia
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lactic acidosis
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic acidosis
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
0 / 2674 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obesity
|
|
|
subjects affected / exposed
|
0 / 2676 (0.00%) |
1 / 2674 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Type 2 diabetes mellitus
|
|
|
subjects affected / exposed
|
1 / 2676 (0.04%) |
2 / 2674 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |