Serious adverse events
|
Phase III Inclisiran-Inclisiran |
Total |
ORION-3 Rollover |
Phase III Placebo-Inclisiran |
Total subjects affected by serious adverse events
|
|
|
|
|
subjects affected / exposed
|
464 / 1512 (30.69%) |
989 / 3274 (30.21%) |
43 / 284 (15.14%) |
482 / 1478 (32.61%) |
number of deaths (all causes)
|
80 |
165 |
4 |
81 |
number of deaths resulting from adverse events
|
0 |
0 |
0 |
0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
|
Benign lung neoplasm
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Basal cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 8 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anaplastic thyroid cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Adenocarcinoma of colon
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Adenocarcinoma metastatic
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Acute myeloid leukaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
1 / 284 (0.35%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
Benign neoplasm of thyroid gland
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder cancer
|
|
|
|
|
subjects affected / exposed
|
5 / 1512 (0.33%) |
8 / 3274 (0.24%) |
1 / 284 (0.35%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 16 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Chronic lymphocytic leukaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchial carcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
1 / 284 (0.35%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Brenner tumour
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Breast cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Breast cancer
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
8 / 3274 (0.24%) |
1 / 284 (0.35%) |
5 / 1478 (0.34%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 16 |
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bowen's disease
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder neoplasm
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder cancer recurrent
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Clear cell renal cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colorectal adenoma
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colorectal cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diffuse large B-cell lymphoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal tract adenoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal stromal tumour
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colorectal adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colon neoplasm
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colon cancer
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
7 / 3274 (0.21%) |
0 / 284 (0.00%) |
5 / 1478 (0.34%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 14 |
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Gastrointestinal neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lip squamous cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Glioblastoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatocellular carcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Invasive ductal breast carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Laryngeal papilloma
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Leukaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lip and/or oral cavity cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lip neoplasm malignant stage unspecified
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malignant melanoma in situ
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malignant melanoma
|
|
|
|
|
subjects affected / exposed
|
3 / 1512 (0.20%) |
5 / 3274 (0.15%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 10 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malignant mediastinal neoplasm
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malignant glioma
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lymphoma
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Lung adenocarcinoma stage IV
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung neoplasm malignant
|
|
|
|
|
subjects affected / exposed
|
7 / 1512 (0.46%) |
11 / 3274 (0.34%) |
0 / 284 (0.00%) |
4 / 1478 (0.27%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 22 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 0 |
0 / 1 |
Lung neoplasm
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung carcinoma cell type unspecified stage IV
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Lung cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Lung squamous cell carcinoma metastatic
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neuroendocrine carcinoma metastatic
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neoplasm prostate
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastatic renal cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastatic malignant melanoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to lymph nodes
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to lung
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to liver
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to central nervous system
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to bone
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
2 / 3274 (0.06%) |
1 / 284 (0.35%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Mantle cell lymphoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Non-Hodgkin's lymphoma stage III
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malignant pleural effusion
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Non-small cell lung cancer
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
0 / 0 |
Non-small cell lung cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Oesophageal carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Oncocytoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatic carcinoma metastatic
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Ovarian cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ovarian cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Ovarian epithelial cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatic carcinoma
|
|
|
|
|
subjects affected / exposed
|
3 / 1512 (0.20%) |
4 / 3274 (0.12%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 8 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 0 |
0 / 1 |
Ovarian adenoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatic neoplasm
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Paraneoplastic syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Parathyroid tumour benign
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Plasma cell myeloma
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prostate cancer
|
|
|
|
|
subjects affected / exposed
|
8 / 1512 (0.53%) |
15 / 3274 (0.46%) |
0 / 284 (0.00%) |
7 / 1478 (0.47%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 32 |
0 / 0 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Small cell lung cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Renal cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sarcoma uterus
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Small cell lung cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Prostate cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
5 / 3274 (0.15%) |
1 / 284 (0.35%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 12 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma of lung
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
4 / 3274 (0.12%) |
0 / 284 (0.00%) |
3 / 1478 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 8 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Squamous cell carcinoma of skin
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
5 / 3274 (0.15%) |
0 / 284 (0.00%) |
3 / 1478 (0.20%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 14 |
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the oral cavity
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Transitional cell carcinoma metastatic
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Triple negative breast cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ureteric cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Uterine leiomyoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Transitional cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
|
|
Aneurysm
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic aneurysm
|
|
|
|
|
subjects affected / exposed
|
5 / 1512 (0.33%) |
12 / 3274 (0.37%) |
0 / 284 (0.00%) |
7 / 1478 (0.47%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 26 |
0 / 0 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic dissection
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
2 / 3274 (0.06%) |
1 / 284 (0.35%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Aortic occlusion
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
1 / 284 (0.35%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
Aortic stenosis
|
|
|
|
|
subjects affected / exposed
|
3 / 1512 (0.20%) |
9 / 3274 (0.27%) |
0 / 284 (0.00%) |
6 / 1478 (0.41%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 18 |
0 / 0 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arterial stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arteriosclerosis
|
|
|
|
|
subjects affected / exposed
|
3 / 1512 (0.20%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
0 / 0 |
Circulatory collapse
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Deep vein thrombosis
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Hypertensive crisis
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Essential hypertension
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Extremity necrosis
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Granulomatosis with polyangiitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haematoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypertension
|
|
|
|
|
subjects affected / exposed
|
3 / 1512 (0.20%) |
6 / 3274 (0.18%) |
1 / 284 (0.35%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 12 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Embolism venous
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive emergency
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive urgency
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 8 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypotension
|
|
|
|
|
subjects affected / exposed
|
4 / 1512 (0.26%) |
6 / 3274 (0.18%) |
1 / 284 (0.35%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 14 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intermittent claudication
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Labile hypertension
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery stenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Penetrating aortic ulcer
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral arterial occlusive disease
|
|
|
|
|
subjects affected / exposed
|
5 / 1512 (0.33%) |
13 / 3274 (0.40%) |
0 / 284 (0.00%) |
8 / 1478 (0.54%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 38 |
0 / 0 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery aneurysm
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery occlusion
|
|
|
|
|
subjects affected / exposed
|
3 / 1512 (0.20%) |
4 / 3274 (0.12%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 10 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Leriche syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral embolism
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Varicose vein
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral vascular disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral ischaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
3 / 1478 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 8 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
General disorders and administration site conditions
|
|
|
|
|
Asthenia
|
|
|
|
|
subjects affected / exposed
|
3 / 1512 (0.20%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 10 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chest discomfort
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chest pain
|
|
|
|
|
subjects affected / exposed
|
6 / 1512 (0.40%) |
17 / 3274 (0.52%) |
3 / 284 (1.06%) |
8 / 1478 (0.54%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 38 |
0 / 3 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Death
|
|
|
|
|
subjects affected / exposed
|
12 / 1512 (0.79%) |
33 / 3274 (1.01%) |
2 / 284 (0.70%) |
19 / 1478 (1.29%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 66 |
0 / 2 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 12 |
0 / 33 |
0 / 2 |
0 / 19 |
Exercise tolerance decreased
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Face oedema
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Multiple organ dysfunction syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Non-cardiac chest pain
|
|
|
|
|
subjects affected / exposed
|
10 / 1512 (0.66%) |
20 / 3274 (0.61%) |
0 / 284 (0.00%) |
10 / 1478 (0.68%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 42 |
0 / 0 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Organ failure
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Pyrexia
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Swelling face
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular stent occlusion
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular stent stenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sudden cardiac death
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 1 |
Immune system disorders
|
|
|
|
|
Hypersensitivity
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Immunisation reaction
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sarcoidosis
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
|
|
Perineal fistula
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Benign prostatic hyperplasia
|
|
|
|
|
subjects affected / exposed
|
7 / 1512 (0.46%) |
9 / 3274 (0.27%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 18 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Breast necrosis
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cystocele
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Postmenopausal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prostatitis
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Uterine prolapse
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
|
Acute pulmonary oedema
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute respiratory failure
|
|
|
|
|
subjects affected / exposed
|
9 / 1512 (0.60%) |
28 / 3274 (0.86%) |
2 / 284 (0.70%) |
17 / 1478 (1.15%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 62 |
0 / 3 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 5 |
0 / 1 |
0 / 3 |
Dyspnoea exertional
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchiectasis
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic obstructive pulmonary disease
|
|
|
|
|
subjects affected / exposed
|
8 / 1512 (0.53%) |
17 / 3274 (0.52%) |
0 / 284 (0.00%) |
9 / 1478 (0.61%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 40 |
0 / 0 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic respiratory failure
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
|
|
subjects affected / exposed
|
6 / 1512 (0.40%) |
16 / 3274 (0.49%) |
2 / 284 (0.70%) |
8 / 1478 (0.54%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 32 |
0 / 2 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Asthma
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypoxia
|
|
|
|
|
subjects affected / exposed
|
4 / 1512 (0.26%) |
5 / 3274 (0.15%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 10 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Laryngeal oedema
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nasal disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
1 / 284 (0.35%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Obstructive sleep apnoea syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
4 / 3274 (0.12%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 8 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary oedema
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
3 / 1478 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 6 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumothorax
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Pneumothorax spontaneous
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
|
|
subjects affected / exposed
|
8 / 1512 (0.53%) |
14 / 3274 (0.43%) |
0 / 284 (0.00%) |
6 / 1478 (0.41%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 30 |
0 / 0 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Pulmonary hypertension
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonitis aspiration
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory failure
|
|
|
|
|
subjects affected / exposed
|
3 / 1512 (0.20%) |
6 / 3274 (0.18%) |
0 / 284 (0.00%) |
3 / 1478 (0.20%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 12 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Pulmonary sarcoidosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Psychiatric disorders
|
|
|
|
|
Completed suicide
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 1 |
Confusional state
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
4 / 3274 (0.12%) |
0 / 284 (0.00%) |
3 / 1478 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 8 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Psychotic disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Depression
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Generalised anxiety disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Major depression
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mental status changes
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Conversion disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Suicidal ideation
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Product issues
|
|
|
|
|
Device dislocation
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device loosening
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device malfunction
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device occlusion
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Investigations
|
|
|
|
|
Troponin T increased
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prostatic specific antigen increased
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oxygen saturation decreased
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myocardial necrosis marker increased
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic enzyme increased
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemoglobin decreased
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood creatinine increased
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anticoagulation drug level above therapeutic
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Troponin increased
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
|
|
Acetabulum fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Alcohol poisoning
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Concussion
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Back injury
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic restenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ankle fracture
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
6 / 3274 (0.18%) |
0 / 284 (0.00%) |
4 / 1478 (0.27%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 12 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Animal bite
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fall
|
|
|
|
|
subjects affected / exposed
|
6 / 1512 (0.40%) |
6 / 3274 (0.18%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 12 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Fractured sacrum
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fracture displacement
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fibula fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Femoral neck fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Heat stroke
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hip fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
3 / 1478 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 6 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Patella fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Overdose
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar vertebral fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lower limb fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Limb injury
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
3 / 1478 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 6 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ligament rupture
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Joint injury
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Joint dislocation
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Incisional hernia
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Procedural hypotension
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Radius fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Road traffic accident
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Procedural haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative wound complication
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural haematoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
1 / 284 (0.35%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Periprosthetic fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin laceration
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic haemothorax
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Upper limb fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sternal fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Stomal hernia
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subdural haematoma
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subdural haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tendon rupture
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thermal burn
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thoracic vertebral fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tibia fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Toxicity to various agents
|
|
|
|
|
subjects affected / exposed
|
3 / 1512 (0.20%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular access site haematoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular graft occlusion
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wound dehiscence
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
|
|
Hydrocele
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
|
|
Acute coronary syndrome
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
5 / 3274 (0.15%) |
0 / 284 (0.00%) |
3 / 1478 (0.20%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 10 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute left ventricular failure
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute myocardial infarction
|
|
|
|
|
subjects affected / exposed
|
17 / 1512 (1.12%) |
44 / 3274 (1.34%) |
3 / 284 (1.06%) |
24 / 1478 (1.62%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 104 |
0 / 5 |
0 / 29 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
Angina pectoris
|
|
|
|
|
subjects affected / exposed
|
21 / 1512 (1.39%) |
43 / 3274 (1.31%) |
2 / 284 (0.70%) |
20 / 1478 (1.35%) |
occurrences causally related to treatment / all
|
0 / 21 |
0 / 90 |
0 / 2 |
0 / 22 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
0 / 0 |
Angina unstable
|
|
|
|
|
subjects affected / exposed
|
12 / 1512 (0.79%) |
32 / 3274 (0.98%) |
2 / 284 (0.70%) |
18 / 1478 (1.22%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 70 |
0 / 2 |
0 / 21 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic valve calcification
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic valve stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arrhythmia
|
|
|
|
|
subjects affected / exposed
|
3 / 1512 (0.20%) |
6 / 3274 (0.18%) |
0 / 284 (0.00%) |
3 / 1478 (0.20%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 12 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Arrhythmic storm
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arteriosclerosis coronary artery
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac arrest
|
|
|
|
|
subjects affected / exposed
|
3 / 1512 (0.20%) |
9 / 3274 (0.27%) |
0 / 284 (0.00%) |
6 / 1478 (0.41%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 22 |
0 / 0 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 6 |
0 / 0 |
0 / 3 |
Atrial flutter
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular block complete
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
5 / 3274 (0.15%) |
0 / 284 (0.00%) |
3 / 1478 (0.20%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 10 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular block second degree
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
6 / 3274 (0.18%) |
0 / 284 (0.00%) |
4 / 1478 (0.27%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 12 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrial fibrillation
|
|
|
|
|
subjects affected / exposed
|
17 / 1512 (1.12%) |
35 / 3274 (1.07%) |
3 / 284 (1.06%) |
15 / 1478 (1.01%) |
occurrences causally related to treatment / all
|
0 / 21 |
0 / 80 |
0 / 4 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Cardiac failure
|
|
|
|
|
subjects affected / exposed
|
10 / 1512 (0.66%) |
26 / 3274 (0.79%) |
1 / 284 (0.35%) |
15 / 1478 (1.01%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 74 |
0 / 1 |
0 / 26 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 5 |
0 / 0 |
0 / 3 |
Cardiac failure acute
|
|
|
|
|
subjects affected / exposed
|
4 / 1512 (0.26%) |
7 / 3274 (0.21%) |
0 / 284 (0.00%) |
3 / 1478 (0.20%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 16 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Cardiac failure chronic
|
|
|
|
|
subjects affected / exposed
|
3 / 1512 (0.20%) |
6 / 3274 (0.18%) |
0 / 284 (0.00%) |
3 / 1478 (0.20%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 12 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Cardiac failure congestive
|
|
|
|
|
subjects affected / exposed
|
15 / 1512 (0.99%) |
29 / 3274 (0.89%) |
1 / 284 (0.35%) |
13 / 1478 (0.88%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 78 |
0 / 1 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 0 |
0 / 1 |
Chronic coronary syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiogenic shock
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Cardiomyopathy
|
|
|
|
|
subjects affected / exposed
|
3 / 1512 (0.20%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiorenal syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiovascular insufficiency
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardio-respiratory arrest
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
4 / 3274 (0.12%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 8 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 0 |
0 / 2 |
Chronic left ventricular failure
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Congestive cardiomyopathy
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery disease
|
|
|
|
|
subjects affected / exposed
|
36 / 1512 (2.38%) |
64 / 3274 (1.95%) |
2 / 284 (0.70%) |
26 / 1478 (1.76%) |
occurrences causally related to treatment / all
|
0 / 38 |
0 / 138 |
0 / 2 |
0 / 29 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 0 |
0 / 0 |
Coronary artery occlusion
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myocardial infarction
|
|
|
|
|
subjects affected / exposed
|
12 / 1512 (0.79%) |
33 / 3274 (1.01%) |
2 / 284 (0.70%) |
19 / 1478 (1.29%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 66 |
0 / 2 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 11 |
0 / 1 |
0 / 6 |
Ischaemic cardiomyopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Left ventricular dysfunction
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Left ventricular failure
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mitral valve incompetence
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 10 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diastolic dysfunction
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myocardial ischaemia
|
|
|
|
|
subjects affected / exposed
|
7 / 1512 (0.46%) |
15 / 3274 (0.46%) |
0 / 284 (0.00%) |
8 / 1478 (0.54%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 32 |
0 / 0 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Nodal arrhythmia
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pericarditis
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prinzmetal angina
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sinus bradycardia
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular hypokinesia
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sinus tachycardia
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
2 / 3274 (0.06%) |
1 / 284 (0.35%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular extrasystoles
|
|
|
|
|
subjects affected / exposed
|
3 / 1512 (0.20%) |
4 / 3274 (0.12%) |
1 / 284 (0.35%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 8 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular fibrillation
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
5 / 3274 (0.15%) |
0 / 284 (0.00%) |
3 / 1478 (0.20%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 10 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Sinus node dysfunction
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular tachycardia
|
|
|
|
|
subjects affected / exposed
|
4 / 1512 (0.26%) |
10 / 3274 (0.31%) |
0 / 284 (0.00%) |
6 / 1478 (0.41%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 22 |
0 / 0 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
|
|
Basal ganglia haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aphasia
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bell's palsy
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Carotid arteriosclerosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Carotid artery disease
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Carotid artery stenosis
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
4 / 3274 (0.12%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 8 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Carpal tunnel syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebrovascular accident
|
|
|
|
|
subjects affected / exposed
|
8 / 1512 (0.53%) |
14 / 3274 (0.43%) |
2 / 284 (0.70%) |
4 / 1478 (0.27%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 30 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 1 |
Cerebellar haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
3 / 3274 (0.09%) |
1 / 284 (0.35%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Cerebral infarction
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
4 / 3274 (0.12%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 8 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral ischaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cauda equina syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
1 / 284 (0.35%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
Cerebrovascular disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cervical cord compression
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cortical laminar necrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dementia Alzheimer's type
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dizziness
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
4 / 3274 (0.12%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 10 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic cerebral infarction
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Encephalopathy
|
|
|
|
|
subjects affected / exposed
|
3 / 1512 (0.20%) |
4 / 3274 (0.12%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 8 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhage intracranial
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Intracranial mass
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Embolic stroke
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic stroke
|
|
|
|
|
subjects affected / exposed
|
16 / 1512 (1.06%) |
26 / 3274 (0.79%) |
0 / 284 (0.00%) |
10 / 1478 (0.68%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 56 |
0 / 0 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 4 |
0 / 0 |
0 / 0 |
Lacunar infarction
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lacunar stroke
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Loss of consciousness
|
|
|
|
|
subjects affected / exposed
|
4 / 1512 (0.26%) |
4 / 3274 (0.12%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 8 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar radiculopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
1 / 284 (0.35%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Paralysis
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Migraine
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myelopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nervous system disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Optic neuritis
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metabolic encephalopathy
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Parkinson's disease
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Polyneuropathy
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Presyncope
|
|
|
|
|
subjects affected / exposed
|
3 / 1512 (0.20%) |
4 / 3274 (0.12%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 8 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sciatica
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subarachnoid haemorrhage
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Syncope
|
|
|
|
|
subjects affected / exposed
|
11 / 1512 (0.73%) |
18 / 3274 (0.55%) |
1 / 284 (0.35%) |
6 / 1478 (0.41%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 38 |
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Thalamus haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
|
|
subjects affected / exposed
|
5 / 1512 (0.33%) |
13 / 3274 (0.40%) |
1 / 284 (0.35%) |
7 / 1478 (0.47%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 26 |
0 / 1 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular encephalopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vasogenic cerebral oedema
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
|
|
Anaemia
|
|
|
|
|
subjects affected / exposed
|
3 / 1512 (0.20%) |
7 / 3274 (0.21%) |
0 / 284 (0.00%) |
4 / 1478 (0.27%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 14 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anaemia macrocytic
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Iron deficiency anaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lymphadenitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Microcytic anaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
1 / 284 (0.35%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
Deficiency anaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood loss anaemia
|
|
|
|
|
subjects affected / exposed
|
3 / 1512 (0.20%) |
6 / 3274 (0.18%) |
0 / 284 (0.00%) |
3 / 1478 (0.20%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 12 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
|
|
Ear canal stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Meniere's disease
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vertigo
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
4 / 3274 (0.12%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 8 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vestibular disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
1 / 284 (0.35%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Otosclerosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
|
|
Cataract
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diplopia
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Retinal detachment
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Retinal vein thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
|
|
Anal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal hernia
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
1 / 284 (0.35%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
|
|
subjects affected / exposed
|
6 / 1512 (0.40%) |
8 / 3274 (0.24%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 16 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain lower
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
5 / 3274 (0.15%) |
0 / 284 (0.00%) |
3 / 1478 (0.20%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 10 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal fat apron
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Faecaloma
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ascites
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colitis
|
|
|
|
|
subjects affected / exposed
|
5 / 1512 (0.33%) |
5 / 3274 (0.15%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 10 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colitis ischaemic
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Constipation
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Enteritis
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulum
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulum intestinal
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Duodenogastric reflux
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dyspepsia
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
5 / 3274 (0.15%) |
0 / 284 (0.00%) |
3 / 1478 (0.20%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 10 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastric fistula
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastric haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Gastric ulcer
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastric volvulus
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastritis
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal atony
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrooesophageal reflux disease
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhoids
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ileus
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
2 / 3274 (0.06%) |
1 / 284 (0.35%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Incarcerated inguinal hernia
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
1 / 284 (0.35%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
5 / 1512 (0.33%) |
9 / 3274 (0.27%) |
0 / 284 (0.00%) |
4 / 1478 (0.27%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 22 |
0 / 0 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal ischaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal obstruction
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Intestinal polyp
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Large intestinal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Large intestinal obstruction
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatic cyst
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nausea
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
1 / 284 (0.35%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Obstructive pancreatitis
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal dysplasia
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal mucosal tear
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Large intestine polyp
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
|
|
subjects affected / exposed
|
4 / 1512 (0.26%) |
5 / 3274 (0.15%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 10 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis acute
|
|
|
|
|
subjects affected / exposed
|
4 / 1512 (0.26%) |
5 / 3274 (0.15%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
1 / 4 |
2 / 10 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Pancreatitis chronic
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Proctitis ulcerative
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pylorospasm
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
|
|
subjects affected / exposed
|
3 / 1512 (0.20%) |
6 / 3274 (0.18%) |
0 / 284 (0.00%) |
3 / 1478 (0.20%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 12 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal prolapse
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Retroperitoneal haematoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Retroperitoneal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Salivary duct obstruction
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Small intestinal ulcer haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Terminal ileitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Umbilical hernia
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
5 / 3274 (0.15%) |
0 / 284 (0.00%) |
4 / 1478 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 10 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
3 / 1478 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 6 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vomiting
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
1 / 284 (0.35%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
|
|
Biliary colic
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bile duct stenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic hepatitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
7 / 3274 (0.21%) |
1 / 284 (0.35%) |
4 / 1478 (0.27%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 14 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatomegaly
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
|
|
subjects affected / exposed
|
6 / 1512 (0.40%) |
8 / 3274 (0.24%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 18 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cirrhosis alcoholic
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gallbladder rupture
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic fibrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
1 / 284 (0.35%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis acute
|
|
|
|
|
subjects affected / exposed
|
3 / 1512 (0.20%) |
9 / 3274 (0.27%) |
0 / 284 (0.00%) |
6 / 1478 (0.41%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 18 |
0 / 0 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
|
|
Skin ulcer
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Reactive perforating collagenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic foot
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic ulcer
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rash
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
|
|
Acute kidney injury
|
|
|
|
|
subjects affected / exposed
|
16 / 1512 (1.06%) |
29 / 3274 (0.89%) |
1 / 284 (0.35%) |
12 / 1478 (0.81%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 64 |
0 / 1 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic kidney disease
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
4 / 3274 (0.12%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 8 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
End stage renal disease
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Glomerulonephritis chronic
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haematuria
|
|
|
|
|
subjects affected / exposed
|
4 / 1512 (0.26%) |
4 / 3274 (0.12%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 8 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
6 / 3274 (0.18%) |
0 / 284 (0.00%) |
4 / 1478 (0.27%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 12 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neurogenic bladder
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal failure
|
|
|
|
|
subjects affected / exposed
|
3 / 1512 (0.20%) |
8 / 3274 (0.24%) |
0 / 284 (0.00%) |
5 / 1478 (0.34%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 16 |
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Glomerulonephritis membranous
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal impairment
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal mass
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ureteric obstruction
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ureterolithiasis
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
4 / 3274 (0.12%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 8 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urethral stenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract obstruction
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary retention
|
|
|
|
|
subjects affected / exposed
|
3 / 1512 (0.20%) |
4 / 3274 (0.12%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 8 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
|
|
Hypothyroidism
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Goitre
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperparathyroidism primary
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thyroiditis
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
|
|
Ankylosing spondylitis
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arthralgia
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
7 / 3274 (0.21%) |
0 / 284 (0.00%) |
5 / 1478 (0.34%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 14 |
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral disc degeneration
|
|
|
|
|
subjects affected / exposed
|
3 / 1512 (0.20%) |
4 / 3274 (0.12%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 8 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haematoma muscle
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Muscular weakness
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mobility decreased
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar spinal stenosis
|
|
|
|
|
subjects affected / exposed
|
5 / 1512 (0.33%) |
9 / 3274 (0.27%) |
1 / 284 (0.35%) |
3 / 1478 (0.20%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 22 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Joint instability
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral disc disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Back pain
|
|
|
|
|
subjects affected / exposed
|
8 / 1512 (0.53%) |
8 / 3274 (0.24%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 18 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bursitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Foot deformity
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Scoliosis
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rotator cuff syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
3 / 1478 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 6 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rheumatoid arthritis
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rhabdomyolysis
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal osteoarthritis
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
|
|
subjects affected / exposed
|
16 / 1512 (1.06%) |
36 / 3274 (1.10%) |
0 / 284 (0.00%) |
20 / 1478 (1.35%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 78 |
0 / 0 |
0 / 22 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neck pain
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal stiffness
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal pain
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
4 / 3274 (0.12%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 8 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Systemic lupus erythematosus
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spondylolisthesis
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal synovial cyst
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
1 / 284 (0.35%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal stenosis
|
|
|
|
|
subjects affected / exposed
|
3 / 1512 (0.20%) |
4 / 3274 (0.12%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 8 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal pain
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tenosynovitis
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
|
|
Abscess limb
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anal abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
5 / 3274 (0.15%) |
0 / 284 (0.00%) |
3 / 1478 (0.20%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 10 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Appendicitis perforated
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis bacterial
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
COVID-19
|
|
|
|
|
subjects affected / exposed
|
21 / 1512 (1.39%) |
49 / 3274 (1.50%) |
0 / 284 (0.00%) |
28 / 1478 (1.89%) |
occurrences causally related to treatment / all
|
0 / 21 |
0 / 98 |
0 / 0 |
0 / 28 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 15 |
0 / 0 |
0 / 10 |
Bacteraemia
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
3 / 3274 (0.09%) |
1 / 284 (0.35%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bacterial colitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bacterial infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atypical pneumonia
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
COVID-19 pneumonia
|
|
|
|
|
subjects affected / exposed
|
14 / 1512 (0.93%) |
35 / 3274 (1.07%) |
0 / 284 (0.00%) |
21 / 1478 (1.42%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 72 |
0 / 0 |
0 / 21 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 8 |
0 / 0 |
0 / 5 |
Cellulitis
|
|
|
|
|
subjects affected / exposed
|
7 / 1512 (0.46%) |
15 / 3274 (0.46%) |
1 / 284 (0.35%) |
7 / 1478 (0.47%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 30 |
0 / 1 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis infective
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic sinusitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
1 / 284 (0.35%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device related infection
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Enterobacter pneumonia
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Empyema
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Endocarditis
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Enterobacter infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic foot infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Enterococcal bacteraemia
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Epstein-Barr virus infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gangrene
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
4 / 3274 (0.12%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 8 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
|
|
subjects affected / exposed
|
4 / 1512 (0.26%) |
5 / 3274 (0.15%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 10 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis salmonella
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infective exacerbation of chronic obstructive airways disease
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Herpes zoster meningoencephalitis
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Implant site infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infected bite
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infected skin ulcer
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis viral
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
1 / 284 (0.35%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Influenza
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral discitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Labyrinthitis
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Laryngitis
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Localised infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
|
|
subjects affected / exposed
|
16 / 1512 (1.06%) |
35 / 3274 (1.07%) |
2 / 284 (0.70%) |
17 / 1478 (1.15%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 80 |
0 / 2 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 0 |
0 / 2 |
Neuroborreliosis
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
6 / 3274 (0.18%) |
0 / 284 (0.00%) |
4 / 1478 (0.27%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 16 |
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteomyelitis chronic
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peritonitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lower respiratory tract infection
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
5 / 3274 (0.15%) |
0 / 284 (0.00%) |
4 / 1478 (0.27%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 10 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative wound infection
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post-acute COVID-19 syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin infection
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sinusitis
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Septic shock
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
6 / 3274 (0.18%) |
0 / 284 (0.00%) |
5 / 1478 (0.34%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 12 |
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Sepsis
|
|
|
|
|
subjects affected / exposed
|
4 / 1512 (0.26%) |
15 / 3274 (0.46%) |
3 / 284 (1.06%) |
8 / 1478 (0.54%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 30 |
0 / 3 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pyelitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia bacterial
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia viral
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
1 / 284 (0.35%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Streptococcal urinary tract infection
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wound sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wound infection
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
4 / 3274 (0.12%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 8 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Viral infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
|
|
subjects affected / exposed
|
3 / 1512 (0.20%) |
4 / 3274 (0.12%) |
1 / 284 (0.35%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 10 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
|
|
subjects affected / exposed
|
9 / 1512 (0.60%) |
14 / 3274 (0.43%) |
0 / 284 (0.00%) |
5 / 1478 (0.34%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 30 |
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tooth abscess
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subcutaneous abscess
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Viraemia
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
|
|
Hyperglycaemia
|
|
|
|
|
subjects affected / exposed
|
3 / 1512 (0.20%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypercalcaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gout
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic ketoacidosis
|
|
|
|
|
subjects affected / exposed
|
4 / 1512 (0.26%) |
4 / 3274 (0.12%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 10 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperglycaemic hyperosmolar nonketotic syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetes mellitus
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
1 / 284 (0.35%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dehydration
|
|
|
|
|
subjects affected / exposed
|
4 / 1512 (0.26%) |
5 / 3274 (0.15%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 10 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cachexia
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Diabetes mellitus inadequate control
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
2 / 1478 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
|
|
subjects affected / exposed
|
2 / 1512 (0.13%) |
2 / 3274 (0.06%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypertriglyceridaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypervolaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
4 / 3274 (0.12%) |
0 / 284 (0.00%) |
4 / 1478 (0.27%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 8 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
|
|
subjects affected / exposed
|
4 / 1512 (0.26%) |
7 / 3274 (0.21%) |
0 / 284 (0.00%) |
3 / 1478 (0.20%) |
occurrences causally related to treatment / all
|
1 / 4 |
2 / 14 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
|
|
subjects affected / exposed
|
3 / 1512 (0.20%) |
4 / 3274 (0.12%) |
1 / 284 (0.35%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 10 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
|
|
subjects affected / exposed
|
3 / 1512 (0.20%) |
3 / 3274 (0.09%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypovolaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 1512 (0.07%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
0 / 1478 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Iron deficiency
|
|
|
|
|
subjects affected / exposed
|
0 / 1512 (0.00%) |
1 / 3274 (0.03%) |
0 / 284 (0.00%) |
1 / 1478 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |