Serious adverse events
|
Zoster-022 GSK1437173A Group |
Zoster-022 Placebo Group |
Zoster-022/006 Pooled GSK1437173A Group |
Zoster-022/006 Pooled Placebo Group |
Total subjects affected by serious adverse events
|
|
|
|
|
subjects affected / exposed
|
1153 / 6950 (16.59%) |
1214 / 6950 (17.47%) |
1447 / 8758 (16.52%) |
1521 / 8773 (17.34%) |
number of deaths (all causes)
|
426 |
459 |
539 |
580 |
number of deaths resulting from adverse events
|
1 |
0 |
1 |
0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
|
Abdominal neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Acral lentiginous melanoma
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute monocytic leukaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Acute myeloid leukaemia
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
1 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 2 |
Acute promyelocytic leukaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
3 / 6950 (0.04%) |
1 / 8758 (0.01%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
Adenocarcinoma gastric
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
1 / 6950 (0.01%) |
4 / 8758 (0.05%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 1 |
0 / 4 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 3 |
0 / 0 |
Adenocarcinoma of colon
|
|
|
|
|
subjects affected / exposed
|
4 / 6950 (0.06%) |
4 / 6950 (0.06%) |
5 / 8758 (0.06%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 1 |
Adenocarcinoma pancreas
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 2 |
Adrenal adenoma
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Adrenal gland cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anaplastic astrocytoma
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Anaplastic thyroid cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
B precursor type acute leukaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
B-cell lymphoma
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
2 / 6950 (0.03%) |
1 / 8758 (0.01%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Basal cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
5 / 6950 (0.07%) |
3 / 6950 (0.04%) |
7 / 8758 (0.08%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Benign neoplasm of bladder
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Benign neoplasm of orbit
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Benign neoplasm of thyroid gland
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Benign ovarian tumour
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Benign renal neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bile duct adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bile duct cancer
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
3 / 8758 (0.03%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 3 |
0 / 0 |
Bladder cancer
|
|
|
|
|
subjects affected / exposed
|
6 / 6950 (0.09%) |
13 / 6950 (0.19%) |
7 / 8758 (0.08%) |
18 / 8773 (0.21%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 13 |
0 / 7 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 3 |
Bladder cancer recurrent
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
1 / 6950 (0.01%) |
2 / 8758 (0.02%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder neoplasm
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
4 / 6950 (0.06%) |
3 / 8758 (0.03%) |
7 / 8773 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 2 |
Bladder papilloma
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
2 / 6950 (0.03%) |
1 / 8758 (0.01%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma recurrent
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Bone cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Bowen’s disease
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Brain cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Brain neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Brain neoplasm benign
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Brain neoplasm malignant
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
Breast cancer
|
|
|
|
|
subjects affected / exposed
|
5 / 6950 (0.07%) |
4 / 6950 (0.06%) |
6 / 8758 (0.07%) |
7 / 8773 (0.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Breast cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
1 / 8758 (0.01%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Bronchial carcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
Carcinoid tumour of the small bowel
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Carcinoid tumour pulmonary
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Central nervous system neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Cervix carcinoma recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholangiocarcinoma
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
3 / 6950 (0.04%) |
3 / 8758 (0.03%) |
6 / 8773 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 3 |
0 / 5 |
Cholesteatoma
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic lymphocytic leukaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Chronic myeloid leukaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Colon adenoma
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colon cancer
|
|
|
|
|
subjects affected / exposed
|
9 / 6950 (0.13%) |
6 / 6950 (0.09%) |
11 / 8758 (0.13%) |
12 / 8773 (0.14%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 6 |
0 / 11 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 3 |
0 / 7 |
Colon cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
3 / 6950 (0.04%) |
3 / 8758 (0.03%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 3 |
0 / 3 |
Colon neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Diffuse large B-cell lymphoma
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Diffuse large B-cell lymphoma stage IV
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Endometrial adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
Fallopian tube cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Follicular thyroid cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gallbladder cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Gastric cancer
|
|
|
|
|
subjects affected / exposed
|
6 / 6950 (0.09%) |
3 / 6950 (0.04%) |
9 / 8758 (0.10%) |
6 / 8773 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
0 / 9 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 6 |
0 / 4 |
Gastrointestinal carcinoma
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
Gastrointestinal stromal tumour
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal tract adenoma
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Glioblastoma
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Glioblastoma multiforme
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Hepatic cancer
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
6 / 6950 (0.09%) |
4 / 8758 (0.05%) |
6 / 8773 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 5 |
0 / 4 |
0 / 5 |
Hepatic cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
Hepatic neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
Hepatocellular carcinoma
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
1 / 6950 (0.01%) |
3 / 8758 (0.03%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
0 / 2 |
Hypergammaglobulinaemia benign monoclonal
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Invasive ductal breast carcinoma
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
2 / 6950 (0.03%) |
3 / 8758 (0.03%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Invasive lobular breast carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Invasive papillary breast carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Large cell lung cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Large intestine benign neoplasm
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Laryngeal cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Laryngeal neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Leukaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lip squamous cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lipoma
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
6 / 6950 (0.09%) |
3 / 8758 (0.03%) |
7 / 8773 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 1 |
0 / 5 |
Lung adenocarcinoma metastatic
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
2 / 6950 (0.03%) |
1 / 8758 (0.01%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 4 |
Lung adenocarcinoma stage III
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
6 / 6950 (0.09%) |
4 / 6950 (0.06%) |
7 / 8758 (0.08%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 6 |
0 / 4 |
0 / 7 |
0 / 4 |
Lung neoplasm
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
3 / 6950 (0.04%) |
1 / 8758 (0.01%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 3 |
Lung neoplasm malignant
|
|
|
|
|
subjects affected / exposed
|
22 / 6950 (0.32%) |
13 / 6950 (0.19%) |
27 / 8758 (0.31%) |
16 / 8773 (0.18%) |
occurrences causally related to treatment / all
|
0 / 22 |
0 / 13 |
0 / 27 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 18 |
0 / 10 |
0 / 23 |
0 / 11 |
Lymphoma
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
3 / 6950 (0.04%) |
2 / 8758 (0.02%) |
5 / 8773 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 3 |
Malignant fibrous histiocytoma of bone
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Malignant lymphoma unclassifiable high grade
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malignant mast cell neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Malignant melanoma
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
4 / 6950 (0.06%) |
3 / 8758 (0.03%) |
5 / 8773 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
0 / 1 |
Malignant melanoma in situ
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malignant neoplasm of ampulla of Vater
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
Malignant neoplasm of unknown primary site
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Malignant palate neoplasm
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malignant pleural effusion
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Meningioma
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Mesothelioma
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to adrenals
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Metastases to bone
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
4 / 6950 (0.06%) |
2 / 8758 (0.02%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 2 |
0 / 3 |
Metastases to central nervous system
|
|
|
|
|
subjects affected / exposed
|
4 / 6950 (0.06%) |
2 / 6950 (0.03%) |
4 / 8758 (0.05%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 4 |
0 / 1 |
Metastases to gastrointestinal tract
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Metastases to liver
|
|
|
|
|
subjects affected / exposed
|
5 / 6950 (0.07%) |
5 / 6950 (0.07%) |
7 / 8758 (0.08%) |
5 / 8773 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
0 / 7 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 5 |
0 / 5 |
0 / 5 |
Metastases to lung
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
1 / 6950 (0.01%) |
2 / 8758 (0.02%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 2 |
Metastases to lymph nodes
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to peritoneum
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
0 / 6950 (0.00%) |
4 / 8758 (0.05%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 3 |
0 / 0 |
Metastases to pleura
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Metastases to stomach
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Metastasis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Metastatic carcinoma of the bladder
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
1 / 6950 (0.01%) |
3 / 8758 (0.03%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 3 |
0 / 0 |
Metastatic gastric cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
2 / 6950 (0.03%) |
1 / 8758 (0.01%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 2 |
Metastatic malignant melanoma
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
2 / 6950 (0.03%) |
2 / 8758 (0.02%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 2 |
0 / 2 |
Metastatic neoplasm
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
2 / 6950 (0.03%) |
2 / 8758 (0.02%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 2 |
Metastatic renal cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Metastatic squamous cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Myelodysplastic syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Nasopharyngeal cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neoplasm malignant
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
3 / 6950 (0.04%) |
2 / 8758 (0.02%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 2 |
0 / 3 |
Neoplasm prostate
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Neuroendocrine carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Non-Hodgkin’s lymphoma
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
3 / 6950 (0.04%) |
0 / 8758 (0.00%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
Non-small cell lung cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
Non-small cell lung cancer stage IV
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Oesophageal adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 2 |
Oesophageal adenocarcinoma metastatic
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Oesophageal cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
1 / 6950 (0.01%) |
2 / 8758 (0.02%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
0 / 1 |
Oesophageal carcinoma
|
|
|
|
|
subjects affected / exposed
|
6 / 6950 (0.09%) |
1 / 6950 (0.01%) |
6 / 8758 (0.07%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 1 |
0 / 5 |
0 / 1 |
Oesophageal squamous cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
Ovarian cancer
|
|
|
|
|
subjects affected / exposed
|
4 / 6950 (0.06%) |
0 / 6950 (0.00%) |
6 / 8758 (0.07%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 6 |
0 / 0 |
Ovarian cancer recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Ovarian epithelial cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ovarian fibroma
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ovarian germ cell teratoma benign
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatic carcinoma
|
|
|
|
|
subjects affected / exposed
|
7 / 6950 (0.10%) |
10 / 6950 (0.14%) |
10 / 8758 (0.11%) |
16 / 8773 (0.18%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 10 |
0 / 10 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 7 |
0 / 10 |
0 / 10 |
0 / 16 |
Pancreatic carcinoma metastatic
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
2 / 6950 (0.03%) |
4 / 8758 (0.05%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 4 |
0 / 2 |
Pancreatic neoplasm
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
0 / 6950 (0.00%) |
3 / 8758 (0.03%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
Pancreatic neuroendocrine tumour
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Papillary thyroid cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Paraganglion neoplasm
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Parathyroid tumour benign
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pituitary tumour benign
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Plasma cell myeloma
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
2 / 8758 (0.02%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Prostate cancer
|
|
|
|
|
subjects affected / exposed
|
19 / 6950 (0.27%) |
18 / 6950 (0.26%) |
22 / 8758 (0.25%) |
23 / 8773 (0.26%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 18 |
0 / 22 |
0 / 23 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 5 |
0 / 4 |
0 / 5 |
Prostate cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
2 / 6950 (0.03%) |
5 / 8758 (0.06%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 5 |
0 / 1 |
Prostate cancer recurrent
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
0 / 6950 (0.00%) |
4 / 8758 (0.05%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
Prostate cancer stage IV
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Prostatic adenoma
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
4 / 6950 (0.06%) |
1 / 6950 (0.01%) |
4 / 8758 (0.05%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
0 / 1 |
Rectal adenoma
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
2 / 6950 (0.03%) |
1 / 8758 (0.01%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 2 |
Rectal cancer recurrent
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
2 / 6950 (0.03%) |
1 / 8758 (0.01%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Renal cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 2 |
Renal cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
4 / 6950 (0.06%) |
3 / 8758 (0.03%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
Renal cell carcinoma recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal oncocytoma
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Salivary gland cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Sarcoma
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Small cell lung cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Small cell lung cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
Small intestine adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
Spinal cord neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
3 / 6950 (0.04%) |
2 / 8758 (0.02%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
Squamous cell carcinoma of lung
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Squamous cell carcinoma of skin
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
1 / 8758 (0.01%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 2 |
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 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Sweat gland tumour
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
T-cell lymphoma
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Testicular neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Throat cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
Thyroid cancer
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tongue neoplasm malignant stage unspecified
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Transitional cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Transitional cell carcinoma metastatic
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Urethral neoplasm
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Uterine cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Vulval cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
|
|
Aneurysm
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aneurysm ruptured
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Angiodysplasia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic aneurysm
|
|
|
|
|
subjects affected / exposed
|
6 / 6950 (0.09%) |
2 / 6950 (0.03%) |
6 / 8758 (0.07%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
0 / 1 |
Aortic aneurysm rupture
|
|
|
|
|
subjects affected / exposed
|
4 / 6950 (0.06%) |
4 / 6950 (0.06%) |
4 / 8758 (0.05%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 4 |
0 / 3 |
Aortic arteriosclerosis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic dilatation
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic dissection
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
2 / 6950 (0.03%) |
1 / 8758 (0.01%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
Aortic occlusion
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Aortic rupture
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Aortic stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
8 / 6950 (0.12%) |
0 / 8758 (0.00%) |
10 / 8773 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 8 |
0 / 0 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Arterial disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Arteriosclerosis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
5 / 6950 (0.07%) |
2 / 8758 (0.02%) |
6 / 8773 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 1 |
0 / 3 |
Arteriovenous fistula
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bleeding varicose vein
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Blood pressure inadequately controlled
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Circulatory collapse
|
|
|
|
|
subjects affected / exposed
|
5 / 6950 (0.07%) |
3 / 6950 (0.04%) |
6 / 8758 (0.07%) |
6 / 8773 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 5 |
0 / 5 |
Deep vein thrombosis
|
|
|
|
|
subjects affected / exposed
|
6 / 6950 (0.09%) |
9 / 6950 (0.13%) |
6 / 8758 (0.07%) |
11 / 8773 (0.13%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 9 |
0 / 6 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Embolism
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Femoral artery aneurysm
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Femoral artery occlusion
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haematoma
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
6 / 6950 (0.09%) |
1 / 8758 (0.01%) |
9 / 8773 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Haemodynamic instability
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
3 / 6950 (0.04%) |
1 / 8758 (0.01%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
Hypertension
|
|
|
|
|
subjects affected / exposed
|
22 / 6950 (0.32%) |
25 / 6950 (0.36%) |
25 / 8758 (0.29%) |
32 / 8773 (0.36%) |
occurrences causally related to treatment / all
|
0 / 22 |
0 / 25 |
0 / 25 |
0 / 32 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
0 / 0 |
Hypertensive crisis
|
|
|
|
|
subjects affected / exposed
|
7 / 6950 (0.10%) |
6 / 6950 (0.09%) |
8 / 8758 (0.09%) |
7 / 8773 (0.08%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
0 / 8 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive emergency
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypotension
|
|
|
|
|
subjects affected / exposed
|
6 / 6950 (0.09%) |
5 / 6950 (0.07%) |
6 / 8758 (0.07%) |
6 / 8773 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Inferior vena caval occlusion
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intermittent claudication
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Internal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Labile hypertension
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Microscopic polyangiitis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Necrosis ischaemic
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Orthostatic hypertension
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Orthostatic hypotension
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
4 / 6950 (0.06%) |
3 / 8758 (0.03%) |
5 / 8773 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral arterial occlusive disease
|
|
|
|
|
subjects affected / exposed
|
6 / 6950 (0.09%) |
6 / 6950 (0.09%) |
6 / 8758 (0.07%) |
7 / 8773 (0.08%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Peripheral artery aneurysm
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral embolism
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral ischaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral vascular disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral venous disease
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Shock haemorrhagic
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Superior vena cava syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Temporal arteritis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
2 / 8758 (0.02%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thromboangiitis obliterans
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thrombophlebitis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thrombosis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
2 / 6950 (0.03%) |
1 / 8758 (0.01%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Varicose ulceration
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Varicose vein
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vasculitis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Venous thrombosis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Venous thrombosis limb
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
|
|
Hospitalisation
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal polypectomy
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
|
|
Accidental death
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Administration site erythema
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Administration site pain
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Adverse drug reaction
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Asthenia
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
4 / 8758 (0.05%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
Cardiac death
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Chest discomfort
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
3 / 6950 (0.04%) |
0 / 8758 (0.00%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chest pain
|
|
|
|
|
subjects affected / exposed
|
20 / 6950 (0.29%) |
19 / 6950 (0.27%) |
24 / 8758 (0.27%) |
22 / 8773 (0.25%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 19 |
0 / 24 |
0 / 22 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chills
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cyst
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Death
|
|
|
|
|
subjects affected / exposed
|
17 / 6950 (0.24%) |
29 / 6950 (0.42%) |
20 / 8758 (0.23%) |
36 / 8773 (0.41%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 29 |
0 / 20 |
0 / 36 |
deaths causally related to treatment / all
|
0 / 17 |
0 / 29 |
0 / 20 |
0 / 36 |
Device battery issue
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device deposit issue
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device dislocation
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
2 / 6950 (0.03%) |
1 / 8758 (0.01%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device failure
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Device leakage
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device occlusion
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Drowning
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 2 |
Fatigue
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
General physical health deterioration
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
2 / 6950 (0.03%) |
2 / 8758 (0.02%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
Generalised oedema
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ill-defined disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Incarcerated hernia
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Inflammation
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malaise
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Multi-organ failure
|
|
|
|
|
subjects affected / exposed
|
9 / 6950 (0.13%) |
12 / 6950 (0.17%) |
12 / 8758 (0.14%) |
12 / 8773 (0.14%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 12 |
0 / 12 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 9 |
0 / 11 |
0 / 12 |
0 / 11 |
Non-cardiac chest pain
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
4 / 6950 (0.06%) |
0 / 8758 (0.00%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Organ failure
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
1 / 6950 (0.01%) |
2 / 8758 (0.02%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
Pain
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral swelling
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
2 / 6950 (0.03%) |
1 / 8758 (0.01%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
1 / 6950 (0.01%) |
3 / 8758 (0.03%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
1 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Strangulated hernia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sudden cardiac death
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
3 / 6950 (0.04%) |
2 / 8758 (0.02%) |
6 / 8773 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 2 |
0 / 6 |
Sudden death
|
|
|
|
|
subjects affected / exposed
|
13 / 6950 (0.19%) |
4 / 6950 (0.06%) |
16 / 8758 (0.18%) |
6 / 8773 (0.07%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 4 |
0 / 16 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 13 |
0 / 4 |
0 / 16 |
0 / 6 |
Systemic inflammatory response syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Thrombosis in device
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
|
|
Allergic granulomatous angiitis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Amyloidosis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anaphylactic reaction
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Drug hypersensitivity
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
|
|
Atrophic vulvovaginitis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Benign prostatic hyperplasia
|
|
|
|
|
subjects affected / exposed
|
9 / 6950 (0.13%) |
7 / 6950 (0.10%) |
10 / 8758 (0.11%) |
8 / 8773 (0.09%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 7 |
0 / 10 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Breast dysplasia
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ovarian cyst
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prostatic obstruction
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prostatitis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
2 / 6950 (0.03%) |
1 / 8758 (0.01%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prostatomegaly
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectocele
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Uterine polyp
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Uterine prolapse
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
4 / 6950 (0.06%) |
0 / 8758 (0.00%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vaginal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vaginal prolapse
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vaginal ulceration
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
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
|
2 / 6950 (0.03%) |
3 / 6950 (0.04%) |
2 / 8758 (0.02%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 3 |
Acute respiratory failure
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
4 / 6950 (0.06%) |
2 / 8758 (0.02%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 2 |
0 / 4 |
Aspiration
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
Asthma
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
4 / 6950 (0.06%) |
5 / 8758 (0.06%) |
6 / 8773 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atelectasis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchiectasis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchitis chronic
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
1 / 8758 (0.01%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Bronchospasm
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
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
|
21 / 6950 (0.30%) |
18 / 6950 (0.26%) |
27 / 8758 (0.31%) |
21 / 8773 (0.24%) |
occurrences causally related to treatment / all
|
0 / 21 |
0 / 18 |
0 / 27 |
0 / 21 |
deaths causally related to treatment / all
|
0 / 8 |
0 / 7 |
0 / 9 |
0 / 9 |
Diaphragmatic disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
4 / 6950 (0.06%) |
4 / 8758 (0.05%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Emphysema
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
Epistaxis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
3 / 6950 (0.04%) |
1 / 8758 (0.01%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemoptysis
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
0 / 6950 (0.00%) |
3 / 8758 (0.03%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemothorax
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperventilation
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypoxia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Idiopathic pulmonary fibrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Interstitial lung disease
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
Lung disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
1 / 8758 (0.01%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Nasal polyps
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nasal septum deviation
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pleural calcification
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
|
|
subjects affected / exposed
|
5 / 6950 (0.07%) |
8 / 6950 (0.12%) |
8 / 8758 (0.09%) |
10 / 8773 (0.11%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 8 |
0 / 8 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 3 |
0 / 0 |
Pleurisy
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pleuritic pain
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia aspiration
|
|
|
|
|
subjects affected / exposed
|
10 / 6950 (0.14%) |
3 / 6950 (0.04%) |
11 / 8758 (0.13%) |
6 / 8773 (0.07%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 3 |
0 / 11 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 7 |
0 / 3 |
0 / 8 |
0 / 5 |
Pneumothorax
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary cavitation
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary congestion
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
|
|
subjects affected / exposed
|
15 / 6950 (0.22%) |
21 / 6950 (0.30%) |
19 / 8758 (0.22%) |
28 / 8773 (0.32%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 21 |
0 / 19 |
0 / 28 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 9 |
0 / 6 |
0 / 11 |
Pulmonary fibrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
3 / 6950 (0.04%) |
0 / 8758 (0.00%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 3 |
Pulmonary mass
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary oedema
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
4 / 6950 (0.06%) |
3 / 8758 (0.03%) |
5 / 8773 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 2 |
0 / 3 |
Respiratory arrest
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
0 / 6950 (0.00%) |
3 / 8758 (0.03%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
0 / 1 |
Respiratory distress
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
2 / 6950 (0.03%) |
3 / 8758 (0.03%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 1 |
Respiratory failure
|
|
|
|
|
subjects affected / exposed
|
15 / 6950 (0.22%) |
15 / 6950 (0.22%) |
20 / 8758 (0.23%) |
23 / 8773 (0.26%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 15 |
0 / 20 |
0 / 23 |
deaths causally related to treatment / all
|
0 / 11 |
0 / 11 |
0 / 16 |
0 / 15 |
Sleep apnoea syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
|
|
Abnormal behaviour
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute psychosis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Affective disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Alcohol withdrawal syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anxiety disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Breathing-related sleep disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Completed suicide
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 4 |
Confusional state
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Delirium
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
3 / 6950 (0.04%) |
2 / 8758 (0.02%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Delirium febrile
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Depressed mood
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Depression
|
|
|
|
|
subjects affected / exposed
|
4 / 6950 (0.06%) |
3 / 6950 (0.04%) |
5 / 8758 (0.06%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Disorientation
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hallucination
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Major depression
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mental disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mental disorder due to a general medical condition
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mental status changes
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Panic attack
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Panic disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Psychotic disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Schizoaffective disorder bipolar type
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Schizophrenia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Somatoform disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Suicidal ideation
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Investigations
|
|
|
|
|
Anticoagulation drug level above therapeutic
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood creatine phosphokinase increased
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood glucose fluctuation
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood pressure increased
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
C-reactive protein increased
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemoglobin decreased
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Heart rate decreased
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Liver function test abnormal
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Weight increased
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
|
|
Accident
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Accidental overdose
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acetabulum fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aneurysm perforation
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Ankle fracture
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
5 / 6950 (0.07%) |
4 / 8758 (0.05%) |
7 / 8773 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Back injury
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bone fissure
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Burns third degree
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Carbon monoxide poisoning
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
Cervical vertebral fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Chemical poisoning
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chest injury
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Clavicle fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Comminuted fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Compression fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Concussion
|
|
|
|
|
subjects affected / exposed
|
4 / 6950 (0.06%) |
3 / 6950 (0.04%) |
4 / 8758 (0.05%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Contusion
|
|
|
|
|
subjects affected / exposed
|
4 / 6950 (0.06%) |
5 / 6950 (0.07%) |
4 / 8758 (0.05%) |
6 / 8773 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery reocclusion
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery restenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Craniocerebral injury
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Deep vein thrombosis postoperative
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Eye penetration
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Face injury
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Facial bones fracture
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
4 / 6950 (0.06%) |
3 / 8758 (0.03%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Fall
|
|
|
|
|
subjects affected / exposed
|
8 / 6950 (0.12%) |
5 / 6950 (0.07%) |
9 / 8758 (0.10%) |
5 / 8773 (0.06%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
0 / 9 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
0 / 1 |
Femoral neck fracture
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
6 / 6950 (0.09%) |
4 / 8758 (0.05%) |
10 / 8773 (0.11%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
0 / 4 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Femur fracture
|
|
|
|
|
subjects affected / exposed
|
10 / 6950 (0.14%) |
15 / 6950 (0.22%) |
15 / 8758 (0.17%) |
17 / 8773 (0.19%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 15 |
0 / 15 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Fibula fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Foot fracture
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
2 / 6950 (0.03%) |
2 / 8758 (0.02%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Forearm fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Foreign body
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fractured sacrum
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gun shot wound
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hand fracture
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
1 / 6950 (0.01%) |
2 / 8758 (0.02%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Head injury
|
|
|
|
|
subjects affected / exposed
|
5 / 6950 (0.07%) |
4 / 6950 (0.06%) |
5 / 8758 (0.06%) |
6 / 8773 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
Hip fracture
|
|
|
|
|
subjects affected / exposed
|
7 / 6950 (0.10%) |
2 / 6950 (0.03%) |
9 / 8758 (0.10%) |
6 / 8773 (0.07%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 2 |
0 / 9 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
Humerus fracture
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
6 / 6950 (0.09%) |
3 / 8758 (0.03%) |
6 / 8773 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Incisional hernia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Injury
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Jaw fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Joint dislocation
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
0 / 6950 (0.00%) |
3 / 8758 (0.03%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Joint injury
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
2 / 6950 (0.03%) |
2 / 8758 (0.02%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Kidney contusion
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Laceration
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
2 / 6950 (0.03%) |
2 / 8758 (0.02%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Ligament sprain
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Limb crushing injury
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Limb injury
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
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 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar vertebral fracture
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
2 / 6950 (0.03%) |
2 / 8758 (0.02%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Meniscus injury
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
2 / 6950 (0.03%) |
3 / 8758 (0.03%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Multiple fractures
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Multiple injuries
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
2 / 6950 (0.03%) |
1 / 8758 (0.01%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Muscle rupture
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Overdose
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
3 / 8758 (0.03%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Patella fracture
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
1 / 6950 (0.01%) |
3 / 8758 (0.03%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic fracture
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
4 / 6950 (0.06%) |
2 / 8758 (0.02%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Pneumothorax traumatic
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural complication
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
2 / 6950 (0.03%) |
1 / 8758 (0.01%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Post procedural haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
3 / 6950 (0.04%) |
0 / 8758 (0.00%) |
5 / 8773 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural pulmonary embolism
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative wound complication
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Procedural intestinal perforation
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Procedural pain
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pubis fracture
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
3 / 6950 (0.04%) |
2 / 8758 (0.02%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Radius fracture
|
|
|
|
|
subjects affected / exposed
|
5 / 6950 (0.07%) |
5 / 6950 (0.07%) |
7 / 8758 (0.08%) |
9 / 8773 (0.10%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
0 / 7 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory fume inhalation disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
Rib fracture
|
|
|
|
|
subjects affected / exposed
|
6 / 6950 (0.09%) |
7 / 6950 (0.10%) |
6 / 8758 (0.07%) |
7 / 8773 (0.08%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Road traffic accident
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Skin wound
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skull fracture
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
0 / 6950 (0.00%) |
4 / 8758 (0.05%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 4 |
0 / 0 |
Snake bite
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
|
|
subjects affected / exposed
|
6 / 6950 (0.09%) |
1 / 6950 (0.01%) |
8 / 8758 (0.09%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
0 / 8 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal cord injury
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal cord injury cervical
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Splenic rupture
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sternal fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subdural haematoma
|
|
|
|
|
subjects affected / exposed
|
9 / 6950 (0.13%) |
6 / 6950 (0.09%) |
9 / 8758 (0.10%) |
7 / 8773 (0.08%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 6 |
0 / 9 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 4 |
0 / 2 |
Subdural haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
Synovial rupture
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tendon rupture
|
|
|
|
|
subjects affected / exposed
|
4 / 6950 (0.06%) |
4 / 6950 (0.06%) |
4 / 8758 (0.05%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thermal burn
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thoracic vertebral fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tibia fracture
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
3 / 6950 (0.04%) |
3 / 8758 (0.03%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Toxicity to various agents
|
|
|
|
|
subjects affected / exposed
|
4 / 6950 (0.06%) |
2 / 6950 (0.03%) |
6 / 8758 (0.07%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic intracranial haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 2 |
Ulna fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Upper limb fracture
|
|
|
|
|
subjects affected / exposed
|
4 / 6950 (0.06%) |
4 / 6950 (0.06%) |
6 / 8758 (0.07%) |
5 / 8773 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular graft occlusion
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular pseudoaneurysm
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wound
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wound dehiscence
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wound evisceration
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Wound haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wrist fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
|
|
Congenital cystic kidney disease
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypertrophic cardiomyopathy
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Pyloric stenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal dysplasia
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Cardiac disorders
|
|
|
|
|
Acute coronary syndrome
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
4 / 6950 (0.06%) |
5 / 8758 (0.06%) |
5 / 8773 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
Acute left ventricular failure
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Acute myocardial infarction
|
|
|
|
|
subjects affected / exposed
|
21 / 6950 (0.30%) |
28 / 6950 (0.40%) |
25 / 8758 (0.29%) |
40 / 8773 (0.46%) |
occurrences causally related to treatment / all
|
1 / 21 |
0 / 28 |
1 / 25 |
0 / 40 |
deaths causally related to treatment / all
|
0 / 10 |
0 / 14 |
0 / 10 |
0 / 21 |
Angina pectoris
|
|
|
|
|
subjects affected / exposed
|
13 / 6950 (0.19%) |
6 / 6950 (0.09%) |
13 / 8758 (0.15%) |
8 / 8773 (0.09%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 6 |
0 / 13 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Angina unstable
|
|
|
|
|
subjects affected / exposed
|
7 / 6950 (0.10%) |
7 / 6950 (0.10%) |
8 / 8758 (0.09%) |
10 / 8773 (0.11%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
0 / 8 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic valve disease
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Aortic valve incompetence
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic valve stenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
3 / 6950 (0.04%) |
2 / 8758 (0.02%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Arrhythmia
|
|
|
|
|
subjects affected / exposed
|
5 / 6950 (0.07%) |
9 / 6950 (0.13%) |
9 / 8758 (0.10%) |
9 / 8773 (0.10%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 9 |
0 / 9 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 4 |
0 / 2 |
Arrhythmia supraventricular
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arteriosclerosis coronary artery
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
3 / 6950 (0.04%) |
1 / 8758 (0.01%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 3 |
Atrial fibrillation
|
|
|
|
|
subjects affected / exposed
|
40 / 6950 (0.58%) |
54 / 6950 (0.78%) |
49 / 8758 (0.56%) |
58 / 8773 (0.66%) |
occurrences causally related to treatment / all
|
0 / 40 |
0 / 54 |
0 / 49 |
0 / 58 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 0 |
0 / 7 |
0 / 0 |
Atrial flutter
|
|
|
|
|
subjects affected / exposed
|
6 / 6950 (0.09%) |
5 / 6950 (0.07%) |
9 / 8758 (0.10%) |
8 / 8773 (0.09%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
0 / 9 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Atrial tachycardia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular block
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
4 / 6950 (0.06%) |
0 / 8758 (0.00%) |
5 / 8773 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Atrioventricular block complete
|
|
|
|
|
subjects affected / exposed
|
4 / 6950 (0.06%) |
2 / 6950 (0.03%) |
5 / 8758 (0.06%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Atrioventricular block first degree
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular block second degree
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
3 / 6950 (0.04%) |
3 / 8758 (0.03%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bradyarrhythmia
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
|
|
subjects affected / exposed
|
4 / 6950 (0.06%) |
8 / 6950 (0.12%) |
5 / 8758 (0.06%) |
9 / 8773 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 8 |
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac arrest
|
|
|
|
|
subjects affected / exposed
|
23 / 6950 (0.33%) |
17 / 6950 (0.24%) |
28 / 8758 (0.32%) |
20 / 8773 (0.23%) |
occurrences causally related to treatment / all
|
0 / 23 |
0 / 17 |
0 / 28 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 22 |
0 / 17 |
0 / 27 |
0 / 20 |
Cardiac disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Cardiac failure
|
|
|
|
|
subjects affected / exposed
|
51 / 6950 (0.73%) |
57 / 6950 (0.82%) |
64 / 8758 (0.73%) |
72 / 8773 (0.82%) |
occurrences causally related to treatment / all
|
0 / 51 |
0 / 57 |
0 / 64 |
0 / 72 |
deaths causally related to treatment / all
|
0 / 31 |
0 / 38 |
0 / 37 |
0 / 48 |
Cardiac failure acute
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac failure chronic
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
6 / 6950 (0.09%) |
5 / 8758 (0.06%) |
7 / 8773 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
0 / 5 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 3 |
0 / 4 |
Cardiac failure congestive
|
|
|
|
|
subjects affected / exposed
|
23 / 6950 (0.33%) |
33 / 6950 (0.47%) |
31 / 8758 (0.35%) |
40 / 8773 (0.46%) |
occurrences causally related to treatment / all
|
0 / 23 |
0 / 33 |
0 / 31 |
0 / 40 |
deaths causally related to treatment / all
|
0 / 9 |
0 / 12 |
0 / 11 |
0 / 14 |
Cardiac tamponade
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Cardiac valve disease
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
1 / 6950 (0.01%) |
3 / 8758 (0.03%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardio-respiratory arrest
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
5 / 6950 (0.07%) |
3 / 8758 (0.03%) |
6 / 8773 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 3 |
0 / 4 |
Cardiogenic shock
|
|
|
|
|
subjects affected / exposed
|
6 / 6950 (0.09%) |
2 / 6950 (0.03%) |
6 / 8758 (0.07%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiomegaly
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiomyopathy
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
2 / 6950 (0.03%) |
1 / 8758 (0.01%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiomyopathy alcoholic
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiopulmonary failure
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiovascular deconditioning
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiovascular insufficiency
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Chronotropic incompetence
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Congestive cardiomyopathy
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
1 / 6950 (0.01%) |
2 / 8758 (0.02%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Cor pulmonale
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery disease
|
|
|
|
|
subjects affected / exposed
|
28 / 6950 (0.40%) |
25 / 6950 (0.36%) |
32 / 8758 (0.37%) |
31 / 8773 (0.35%) |
occurrences causally related to treatment / all
|
0 / 28 |
0 / 25 |
0 / 32 |
0 / 31 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 5 |
0 / 3 |
Coronary artery insufficiency
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
3 / 8758 (0.03%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 3 |
0 / 0 |
Coronary artery occlusion
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery stenosis
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
6 / 6950 (0.09%) |
4 / 8758 (0.05%) |
6 / 8773 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diastolic dysfunction
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Extrasystoles
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Heart valve incompetence
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive heart disease
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic cardiomyopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
4 / 6950 (0.06%) |
0 / 8758 (0.00%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
Left ventricular failure
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
4 / 8758 (0.05%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
Left ventricular hypertrophy
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Mitral valve incompetence
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
3 / 6950 (0.04%) |
2 / 8758 (0.02%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mitral valve stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myocardial infarction
|
|
|
|
|
subjects affected / exposed
|
41 / 6950 (0.59%) |
45 / 6950 (0.65%) |
59 / 8758 (0.67%) |
55 / 8773 (0.63%) |
occurrences causally related to treatment / all
|
0 / 41 |
0 / 45 |
0 / 59 |
0 / 55 |
deaths causally related to treatment / all
|
0 / 24 |
0 / 26 |
0 / 32 |
0 / 31 |
Myocardial ischaemia
|
|
|
|
|
subjects affected / exposed
|
5 / 6950 (0.07%) |
16 / 6950 (0.23%) |
8 / 8758 (0.09%) |
22 / 8773 (0.25%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 16 |
0 / 8 |
0 / 22 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 5 |
0 / 1 |
0 / 9 |
Palpitations
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
3 / 6950 (0.04%) |
1 / 8758 (0.01%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pericardial effusion
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Pericarditis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Right ventricular failure
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
1 / 6950 (0.01%) |
3 / 8758 (0.03%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
Sinus arrest
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sinus node dysfunction
|
|
|
|
|
subjects affected / exposed
|
5 / 6950 (0.07%) |
6 / 6950 (0.09%) |
6 / 8758 (0.07%) |
6 / 8773 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sinus tachycardia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Stress cardiomyopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
0 / 6950 (0.00%) |
4 / 8758 (0.05%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tachyarrhythmia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
2 / 6950 (0.03%) |
3 / 8758 (0.03%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Tricuspid valve incompetence
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular arrhythmia
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular extrasystoles
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular fibrillation
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
3 / 6950 (0.04%) |
2 / 8758 (0.02%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 2 |
0 / 2 |
Ventricular tachycardia
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
6 / 6950 (0.09%) |
3 / 8758 (0.03%) |
6 / 8773 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Nervous system disorders
|
|
|
|
|
Amnesia
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Amyotrophic lateral sclerosis
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
3 / 8758 (0.03%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 1 |
Aphasia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ataxia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Balance disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Basal ganglia haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Basal ganglia infarction
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Basilar artery thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Brain injury
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Brain stem infarction
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Brain stem syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Carotid artery occlusion
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Carotid artery stenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
2 / 8758 (0.02%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Carotid sinus syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Carpal tunnel syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Central nervous system lesion
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebellar haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Cerebellar ischaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral artery embolism
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral artery thrombosis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Cerebral atrophy
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral haemorrhage
|
|
|
|
|
subjects affected / exposed
|
6 / 6950 (0.09%) |
7 / 6950 (0.10%) |
8 / 8758 (0.09%) |
11 / 8773 (0.13%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
0 / 8 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 6 |
0 / 6 |
0 / 10 |
Cerebral infarction
|
|
|
|
|
subjects affected / exposed
|
16 / 6950 (0.23%) |
17 / 6950 (0.24%) |
21 / 8758 (0.24%) |
20 / 8773 (0.23%) |
occurrences causally related to treatment / all
|
0 / 16 |
1 / 17 |
0 / 21 |
1 / 20 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 6 |
0 / 9 |
0 / 7 |
Cerebral ischaemia
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
3 / 6950 (0.04%) |
2 / 8758 (0.02%) |
5 / 8773 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 2 |
0 / 3 |
Cerebrospinal fluid leakage
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebrovascular accident
|
|
|
|
|
subjects affected / exposed
|
34 / 6950 (0.49%) |
31 / 6950 (0.45%) |
45 / 8758 (0.51%) |
38 / 8773 (0.43%) |
occurrences causally related to treatment / all
|
0 / 34 |
1 / 31 |
0 / 45 |
1 / 38 |
deaths causally related to treatment / all
|
0 / 11 |
0 / 17 |
0 / 17 |
0 / 19 |
Cerebrovascular disorder
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
1 / 6950 (0.01%) |
3 / 8758 (0.03%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Cerebrovascular insufficiency
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Cervical myelopathy
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cervicobrachial syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cognitive disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coma
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Dementia
|
|
|
|
|
subjects affected / exposed
|
4 / 6950 (0.06%) |
2 / 6950 (0.03%) |
4 / 8758 (0.05%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
0 / 1 |
Dementia Alzheimer’s type
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Dementia with Lewy bodies
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic coma
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Dizziness
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
5 / 6950 (0.07%) |
3 / 8758 (0.03%) |
9 / 8773 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
0 / 3 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Drop attacks
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dural arteriovenous fistula
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dyspraxia
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Epilepsy
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
4 / 6950 (0.06%) |
2 / 8758 (0.02%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Generalised tonic-clonic seizure
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Guillain-Barre syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
2 / 6950 (0.03%) |
1 / 8758 (0.01%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 2 |
1 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Haemorrhage intracranial
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
2 / 6950 (0.03%) |
1 / 8758 (0.01%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 2 |
Haemorrhagic stroke
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
4 / 6950 (0.06%) |
0 / 8758 (0.00%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
Haemorrhagic transformation stroke
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Headache
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
4 / 8758 (0.05%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hemiparesis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hemiplegia
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hydrocephalus
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypertonia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypoaesthesia
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypoxic-ischaemic encephalopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Intracranial aneurysm
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intraventricular haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Ischaemic stroke
|
|
|
|
|
subjects affected / exposed
|
7 / 6950 (0.10%) |
6 / 6950 (0.09%) |
7 / 8758 (0.08%) |
7 / 8773 (0.08%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
0 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 4 |
0 / 1 |
Lacunar infarction
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
2 / 6950 (0.03%) |
2 / 8758 (0.02%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Loss of consciousness
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
2 / 8758 (0.02%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
0 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Lumbar radiculopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
1 / 8758 (0.01%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Memory impairment
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metabolic encephalopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Miller Fisher syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mixed dementia
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Myasthenia gravis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myoclonus
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nerve compression
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neuralgia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neuritis cranial
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neuropathy peripheral
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Paralysis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Parkinsonism
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Parkinson’s disease
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Partial seizures
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Polyneuropathy
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post herpetic neuralgia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Presyncope
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
2 / 6950 (0.03%) |
1 / 8758 (0.01%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Progressive supranuclear palsy
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Radiculopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Restless legs syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ruptured cerebral aneurysm
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Sciatica
|
|
|
|
|
subjects affected / exposed
|
4 / 6950 (0.06%) |
4 / 6950 (0.06%) |
4 / 8758 (0.05%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Seizure
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
3 / 8758 (0.03%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Senile dementia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Somnolence
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal claudication
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spondylitic myelopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Status epilepticus
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Subarachnoid haemorrhage
|
|
|
|
|
subjects affected / exposed
|
5 / 6950 (0.07%) |
7 / 6950 (0.10%) |
5 / 8758 (0.06%) |
7 / 8773 (0.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 7 |
0 / 5 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 2 |
0 / 5 |
0 / 2 |
Syncope
|
|
|
|
|
subjects affected / exposed
|
11 / 6950 (0.16%) |
20 / 6950 (0.29%) |
15 / 8758 (0.17%) |
24 / 8773 (0.27%) |
occurrences causally related to treatment / all
|
0 / 11 |
1 / 20 |
0 / 15 |
1 / 24 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Thalamic infarction
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thalamus haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Thrombotic cerebral infarction
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Transient global amnesia
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
|
|
subjects affected / exposed
|
20 / 6950 (0.29%) |
14 / 6950 (0.20%) |
22 / 8758 (0.25%) |
19 / 8773 (0.22%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 14 |
0 / 22 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Trigeminal neuralgia
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
VIIIth nerve lesion
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
VIIth nerve paralysis
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
2 / 6950 (0.03%) |
2 / 8758 (0.02%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular dementia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular encephalopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vertebrobasilar insufficiency
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
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
|
6 / 6950 (0.09%) |
13 / 6950 (0.19%) |
9 / 8758 (0.10%) |
15 / 8773 (0.17%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 13 |
0 / 9 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
Anaemia vitamin B12 deficiency
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coagulopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Disseminated intravascular coagulation
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
2 / 8758 (0.02%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Haemorrhagic anaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
2 / 8758 (0.02%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Heparin-induced thrombocytopenia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypersplenism
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Immune thrombocytopenic purpura
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Iron deficiency anaemia
|
|
|
|
|
subjects affected / exposed
|
5 / 6950 (0.07%) |
4 / 6950 (0.06%) |
7 / 8758 (0.08%) |
5 / 8773 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
0 / 7 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lymphadenitis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lymphadenopathy
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lymphadenopathy mediastinal
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Microcytic anaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nephrogenic anaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Normochromic normocytic anaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pernicious anaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Splenic infarction
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
3 / 6950 (0.04%) |
0 / 8758 (0.00%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
Ear and labyrinth disorders
|
|
|
|
|
Sudden hearing loss
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vertigo
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
4 / 6950 (0.06%) |
7 / 8758 (0.08%) |
6 / 8773 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vertigo positional
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
1 / 6950 (0.01%) |
2 / 8758 (0.02%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vestibular disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
3 / 6950 (0.04%) |
0 / 8758 (0.00%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
|
|
Age-related macular degeneration
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Amaurosis fugax
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cataract
|
|
|
|
|
subjects affected / exposed
|
7 / 6950 (0.10%) |
7 / 6950 (0.10%) |
7 / 8758 (0.08%) |
7 / 8773 (0.08%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
0 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Choroidal effusion
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diplopia
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Glaucoma
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Iridocele
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Iritis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lens dislocation
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ocular hypertension
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ocular vascular disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Optic ischaemic neuropathy
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Retinal degeneration
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Retinal detachment
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
4 / 6950 (0.06%) |
0 / 8758 (0.00%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Retinal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vitreous haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
|
|
Abdominal adhesions
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Abdominal discomfort
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal hernia
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
2 / 6950 (0.03%) |
3 / 8758 (0.03%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
7 / 6950 (0.10%) |
1 / 8758 (0.01%) |
8 / 8773 (0.09%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 7 |
0 / 1 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
2 / 6950 (0.03%) |
2 / 8758 (0.02%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal strangulated hernia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anal prolapse
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ascites
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
Autoimmune pancreatitis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Barrett’s oesophagus
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic gastritis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colitis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colitis ischaemic
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
1 / 6950 (0.01%) |
4 / 8758 (0.05%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colitis ulcerative
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Constipation
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
2 / 6950 (0.03%) |
4 / 8758 (0.05%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Crohn’s disease
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diaphragmatic hernia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diaphragmatic hernia, obstructive
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
4 / 6950 (0.06%) |
2 / 8758 (0.02%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Diverticulum
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
3 / 6950 (0.04%) |
5 / 8758 (0.06%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulum intestinal
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
2 / 6950 (0.03%) |
1 / 8758 (0.01%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulum intestinal haemorrhagic
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Duodenal ulcer
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Duodenal ulcer haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Duodenal ulcer perforation
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Enteritis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Enterovesical fistula
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Faecal incontinence
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastric haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastric perforation
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastric polyps
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastric ulcer
|
|
|
|
|
subjects affected / exposed
|
4 / 6950 (0.06%) |
6 / 6950 (0.09%) |
5 / 8758 (0.06%) |
8 / 8773 (0.09%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
0 / 5 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Gastric ulcer haemorrhage
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
4 / 6950 (0.06%) |
2 / 8758 (0.02%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastric ulcer perforation
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Gastritis
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
6 / 6950 (0.09%) |
4 / 8758 (0.05%) |
7 / 8773 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastritis alcoholic
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastritis haemorrhagic
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal angiodysplasia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
4 / 6950 (0.06%) |
6 / 8758 (0.07%) |
6 / 8773 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Gastrooesophageal reflux disease
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
2 / 6950 (0.03%) |
4 / 8758 (0.05%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haematochezia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhoids
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
1 / 6950 (0.01%) |
2 / 8758 (0.02%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hiatus hernia
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ileus
|
|
|
|
|
subjects affected / exposed
|
6 / 6950 (0.09%) |
7 / 6950 (0.10%) |
6 / 8758 (0.07%) |
8 / 8773 (0.09%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
0 / 6 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Incarcerated inguinal hernia
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Incarcerated umbilical hernia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
|
|
subjects affected / exposed
|
5 / 6950 (0.07%) |
10 / 6950 (0.14%) |
6 / 8758 (0.07%) |
13 / 8773 (0.15%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 10 |
0 / 6 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal hernia strangulated
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal congestion
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal infarction
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
Intestinal ischaemia
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
2 / 6950 (0.03%) |
2 / 8758 (0.02%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
0 / 1 |
Intestinal obstruction
|
|
|
|
|
subjects affected / exposed
|
6 / 6950 (0.09%) |
6 / 6950 (0.09%) |
7 / 8758 (0.08%) |
6 / 8773 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 1 |
0 / 3 |
Intestinal perforation
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
2 / 6950 (0.03%) |
1 / 8758 (0.01%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Large intestinal obstruction
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
Large intestine perforation
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
2 / 6950 (0.03%) |
3 / 8758 (0.03%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
Large intestine polyp
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
4 / 6950 (0.06%) |
3 / 8758 (0.03%) |
5 / 8773 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mallory-Weiss syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
2 / 8758 (0.02%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Melaena
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mesenteric artery embolism
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Mesenteric artery thrombosis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Mesenteritis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mouth ulceration
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nausea
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
3 / 8758 (0.03%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Oesophageal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal spasm
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal ulcer
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Oesophageal ulcer haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oesophagitis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
3 / 8758 (0.03%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatic disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
8 / 6950 (0.12%) |
5 / 8758 (0.06%) |
8 / 8773 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 8 |
0 / 5 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Pancreatitis acute
|
|
|
|
|
subjects affected / exposed
|
5 / 6950 (0.07%) |
4 / 6950 (0.06%) |
7 / 8758 (0.08%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 4 |
1 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Peptic ulcer
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peptic ulcer haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peritoneal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pharyngo-oesophageal diverticulum
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumoperitoneum
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Proctitis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
3 / 6950 (0.04%) |
2 / 8758 (0.02%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal perforation
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal polyp
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal prolapse
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Retroperitoneal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Salivary gland calculus
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
4 / 6950 (0.06%) |
3 / 8758 (0.03%) |
5 / 8773 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Subileus
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thrombosis mesenteric vessel
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Umbilical hernia
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
2 / 6950 (0.03%) |
2 / 8758 (0.02%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
2 / 6950 (0.03%) |
3 / 8758 (0.03%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Volvulus
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Vomiting
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
|
|
Acute hepatic failure
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Bile duct obstruction
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bile duct stone
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
3 / 6950 (0.04%) |
3 / 8758 (0.03%) |
5 / 8773 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Biliary colic
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Biliary dilatation
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Biliary dyskinesia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholangitis
|
|
|
|
|
subjects affected / exposed
|
5 / 6950 (0.07%) |
5 / 6950 (0.07%) |
5 / 8758 (0.06%) |
6 / 8773 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Cholangitis acute
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Cholecystitis
|
|
|
|
|
subjects affected / exposed
|
7 / 6950 (0.10%) |
15 / 6950 (0.22%) |
7 / 8758 (0.08%) |
18 / 8773 (0.21%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 15 |
0 / 7 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Cholecystitis acute
|
|
|
|
|
subjects affected / exposed
|
7 / 6950 (0.10%) |
4 / 6950 (0.06%) |
8 / 8758 (0.09%) |
5 / 8773 (0.06%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
0 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Cholecystitis chronic
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
|
|
subjects affected / exposed
|
14 / 6950 (0.20%) |
14 / 6950 (0.20%) |
14 / 8758 (0.16%) |
17 / 8773 (0.19%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 14 |
0 / 14 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Cholestasis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Chronic hepatic failure
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Cirrhosis alcoholic
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Drug-induced liver injury
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Gallbladder perforation
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Hepatic cirrhosis
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
3 / 6950 (0.04%) |
2 / 8758 (0.02%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
Hepatic failure
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
1 / 6950 (0.01%) |
2 / 8758 (0.02%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
0 / 2 |
Hepatic function abnormal
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis acute
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis alcoholic
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Hyperbilirubinaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic hepatitis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Jaundice cholestatic
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
|
|
Actinic keratosis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Angioedema
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Decubitus ulcer
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
2 / 6950 (0.03%) |
1 / 8758 (0.01%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
Dermal cyst
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dermatitis allergic
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dermatitis contact
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dermatomyositis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic foot
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
5 / 6950 (0.07%) |
0 / 8758 (0.00%) |
5 / 8773 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Drug eruption
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Eczema
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
1 / 6950 (0.01%) |
2 / 8758 (0.02%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
1 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Leukoplakia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lichen planus
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Psoriasis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin necrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin ulcer
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
2 / 8758 (0.02%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Stasis dermatitis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urticaria
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
|
|
Acute kidney injury
|
|
|
|
|
subjects affected / exposed
|
18 / 6950 (0.26%) |
19 / 6950 (0.27%) |
23 / 8758 (0.26%) |
22 / 8773 (0.25%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 19 |
0 / 23 |
0 / 22 |
deaths causally related to treatment / all
|
0 / 8 |
0 / 7 |
0 / 12 |
0 / 7 |
Acute prerenal failure
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder neck obstruction
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder perforation
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder prolapse
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Calculus ureteric
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic kidney disease
|
|
|
|
|
subjects affected / exposed
|
4 / 6950 (0.06%) |
11 / 6950 (0.16%) |
4 / 8758 (0.05%) |
13 / 8773 (0.15%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 11 |
0 / 4 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 4 |
Cystitis haemorrhagic
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Cystitis interstitial
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic nephropathy
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dysuria
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Glomerulonephritis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haematuria
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
2 / 6950 (0.03%) |
4 / 8758 (0.05%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nephroangiosclerosis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
|
|
subjects affected / exposed
|
6 / 6950 (0.09%) |
2 / 6950 (0.03%) |
6 / 8758 (0.07%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nephropathy toxic
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neurogenic bladder
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prerenal failure
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal artery occlusion
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal cyst
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
1 / 6950 (0.01%) |
2 / 8758 (0.02%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal failure
|
|
|
|
|
subjects affected / exposed
|
11 / 6950 (0.16%) |
11 / 6950 (0.16%) |
11 / 8758 (0.13%) |
14 / 8773 (0.16%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 11 |
0 / 11 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 7 |
0 / 3 |
0 / 7 |
0 / 5 |
Renal hypertension
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal impairment
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal mass
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Stress urinary incontinence
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tubulointerstitial nephritis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
4 / 6950 (0.06%) |
1 / 8758 (0.01%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urethral haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Urethral meatus stenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urethral stenosis
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
2 / 6950 (0.03%) |
2 / 8758 (0.02%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary incontinence
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Urinary retention
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
3 / 6950 (0.04%) |
4 / 8758 (0.05%) |
6 / 8773 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
|
|
Autoimmune thyroiditis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Basedow’s disease
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cushingoid
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Goitre
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperparathyroidism primary
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperthyroidism
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypopituitarism
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypothyroidism
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
3 / 6950 (0.04%) |
0 / 8758 (0.00%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
|
|
Acquired claw toe
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arthralgia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
2 / 8758 (0.02%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arthrofibrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arthropathy
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Back pain
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
5 / 6950 (0.07%) |
2 / 8758 (0.02%) |
5 / 8773 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bursitis
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cervical spinal stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chondrocalcinosis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chondropathy
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Foot deformity
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gouty arthritis
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
1 / 6950 (0.01%) |
2 / 8758 (0.02%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral disc disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
|
|
subjects affected / exposed
|
5 / 6950 (0.07%) |
4 / 6950 (0.06%) |
6 / 8758 (0.07%) |
7 / 8773 (0.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
0 / 5 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Joint effusion
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar spinal stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Meniscal degeneration
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mixed connective tissue disease
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Muscle spasms
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Muscular weakness
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal pain
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
1 / 6950 (0.01%) |
2 / 8758 (0.02%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myalgia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myositis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
|
|
subjects affected / exposed
|
26 / 6950 (0.37%) |
17 / 6950 (0.24%) |
30 / 8758 (0.34%) |
20 / 8773 (0.23%) |
occurrences causally related to treatment / all
|
0 / 26 |
0 / 17 |
0 / 30 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteochondritis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteochondrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteonecrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
3 / 8758 (0.03%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteoporosis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteoporotic fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pathological fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Polymyalgia rheumatica
|
|
|
|
|
subjects affected / exposed
|
5 / 6950 (0.07%) |
4 / 6950 (0.06%) |
6 / 8758 (0.07%) |
5 / 8773 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
1 / 4 |
0 / 6 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Polymyositis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Pseudarthrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rhabdomyolysis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
1 / 8758 (0.01%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Rheumatoid arthritis
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
1 / 6950 (0.01%) |
2 / 8758 (0.02%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rotator cuff syndrome
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
2 / 6950 (0.03%) |
3 / 8758 (0.03%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sjogren’s syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal column stenosis
|
|
|
|
|
subjects affected / exposed
|
6 / 6950 (0.09%) |
6 / 6950 (0.09%) |
7 / 8758 (0.08%) |
7 / 8773 (0.08%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
0 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal osteoarthritis
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
5 / 6950 (0.07%) |
3 / 8758 (0.03%) |
6 / 8773 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal pain
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spondyloarthropathy
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spondylolisthesis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
3 / 8758 (0.03%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Still’s disease adult onset
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Synovial cyst
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Synovitis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Systemic lupus erythematosus
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tendonitis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tenosynovitis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Trigger finger
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
|
|
Abdominal abscess
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal infection
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abscess neck
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acarodermatitis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Alcaligenes infection
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anal abscess
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anal fistula infection
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anorectal cellulitis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Appendiceal abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
|
|
subjects affected / exposed
|
5 / 6950 (0.07%) |
5 / 6950 (0.07%) |
6 / 8758 (0.07%) |
6 / 8773 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Appendicitis perforated
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arteriosclerotic gangrene
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis bacterial
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis infective
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atypical pneumonia
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Bacteraemia
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bacterial infection
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bacterial sepsis
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
2 / 6950 (0.03%) |
2 / 8758 (0.02%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
0 / 1 |
Bacteriuria
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Biliary tract infection
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
|
|
subjects affected / exposed
|
8 / 6950 (0.12%) |
7 / 6950 (0.10%) |
10 / 8758 (0.11%) |
8 / 8773 (0.09%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 7 |
0 / 10 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
0 / 1 |
Bronchitis bacterial
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchopneumonia
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
4 / 6950 (0.06%) |
2 / 8758 (0.02%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 2 |
0 / 2 |
Candida infection
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Candida sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Candiduria
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cavernous sinus thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
|
|
subjects affected / exposed
|
8 / 6950 (0.12%) |
14 / 6950 (0.20%) |
11 / 8758 (0.13%) |
16 / 8773 (0.18%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 14 |
0 / 11 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
Cholecystitis infective
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium bacteraemia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium difficile colitis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
5 / 6950 (0.07%) |
1 / 8758 (0.01%) |
5 / 8773 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
Clostridium difficile infection
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 2 |
Colonic abscess
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Cystitis
|
|
|
|
|
subjects affected / exposed
|
4 / 6950 (0.06%) |
0 / 6950 (0.00%) |
4 / 8758 (0.05%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cystitis klebsiella
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Device related infection
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic foot infection
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
|
|
subjects affected / exposed
|
5 / 6950 (0.07%) |
11 / 6950 (0.16%) |
5 / 8758 (0.06%) |
13 / 8773 (0.15%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 11 |
0 / 5 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
Empyema
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
2 / 6950 (0.03%) |
1 / 8758 (0.01%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Encephalitis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Encephalitis viral
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Endocarditis
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
0 / 6950 (0.00%) |
4 / 8758 (0.05%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
Enterocolitis viral
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Epididymitis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
7 / 6950 (0.10%) |
4 / 8758 (0.05%) |
9 / 8773 (0.10%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 7 |
1 / 4 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Escherichia infection
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Escherichia sepsis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
2 / 6950 (0.03%) |
1 / 8758 (0.01%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Escherichia urinary tract infection
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fungaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gangrene
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Gastroenteritis
|
|
|
|
|
subjects affected / exposed
|
8 / 6950 (0.12%) |
8 / 6950 (0.12%) |
9 / 8758 (0.10%) |
8 / 8773 (0.09%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 8 |
0 / 9 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Gastroenteritis clostridial
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Gastroenteritis norovirus
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Gastroenteritis salmonella
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis viral
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
2 / 6950 (0.03%) |
3 / 8758 (0.03%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal infection
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Graft infection
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haematoma infection
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Helicobacter gastritis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Helicobacter infection
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis A
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Herpes simplex
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Herpes zoster
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
3 / 6950 (0.04%) |
1 / 8758 (0.01%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Herpes zoster disseminated
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Herpes zoster meningitis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Herpes zoster oticus
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Incision site infection
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infected dermal cyst
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infected skin ulcer
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Infection
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Infectious colitis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infective exacerbation of chronic obstructive airways
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
1 / 6950 (0.01%) |
2 / 8758 (0.02%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Influenza
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
1 / 6950 (0.01%) |
3 / 8758 (0.03%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
Intestinal gangrene
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Kidney infection
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Klebsiella bacteraemia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Klebsiella sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Labyrinthitis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Liver abscess
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
1 / 6950 (0.01%) |
2 / 8758 (0.02%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lobar pneumonia
|
|
|
|
|
subjects affected / exposed
|
4 / 6950 (0.06%) |
8 / 6950 (0.12%) |
4 / 8758 (0.05%) |
9 / 8773 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 8 |
0 / 4 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 3 |
Localised infection
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lower respiratory tract infection
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
2 / 8758 (0.02%) |
5 / 8773 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung infection
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
2 / 6950 (0.03%) |
2 / 8758 (0.02%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 1 |
Medical device site infection
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Meningitis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nasopharyngitis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Necrotising fasciitis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
Necrotising fasciitis streptococcal
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Neuroborreliosis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neutropenic sepsis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Oesophageal candidiasis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ophthalmic herpes zoster
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Orchitis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
3 / 6950 (0.04%) |
0 / 8758 (0.00%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oropharyngeal candidiasis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Otitis media chronic
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ovarian abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatic abscess
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Periodontitis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peritonitis
|
|
|
|
|
subjects affected / exposed
|
4 / 6950 (0.06%) |
4 / 6950 (0.06%) |
5 / 8758 (0.06%) |
5 / 8773 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 5 |
0 / 2 |
Peritonitis bacterial
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pharyngitis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
|
|
subjects affected / exposed
|
70 / 6950 (1.01%) |
81 / 6950 (1.17%) |
96 / 8758 (1.10%) |
93 / 8773 (1.06%) |
occurrences causally related to treatment / all
|
0 / 70 |
0 / 81 |
0 / 96 |
0 / 93 |
deaths causally related to treatment / all
|
0 / 24 |
0 / 38 |
0 / 34 |
0 / 42 |
Pneumonia bacterial
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
0 / 6950 (0.00%) |
3 / 8758 (0.03%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Pneumonia influenzal
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
Pneumonia klebsiella
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
2 / 6950 (0.03%) |
1 / 8758 (0.01%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
Pneumonia pneumococcal
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Pneumonia streptococcal
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia viral
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
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 / 6950 (0.00%) |
3 / 6950 (0.04%) |
0 / 8758 (0.00%) |
6 / 8773 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Postoperative abscess
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
0 / 6950 (0.00%) |
3 / 8758 (0.03%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative wound infection
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pseudomembranous colitis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
Pseudomonas infection
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Psittacosis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Psoas abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary tuberculosis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Purulence
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
4 / 6950 (0.06%) |
5 / 8758 (0.06%) |
6 / 8773 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Pyelonephritis acute
|
|
|
|
|
subjects affected / exposed
|
4 / 6950 (0.06%) |
0 / 6950 (0.00%) |
5 / 8758 (0.06%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal abscess
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal abscess
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory moniliasis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
3 / 6950 (0.04%) |
3 / 8758 (0.03%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Sepsis
|
|
|
|
|
subjects affected / exposed
|
26 / 6950 (0.37%) |
17 / 6950 (0.24%) |
32 / 8758 (0.37%) |
26 / 8773 (0.30%) |
occurrences causally related to treatment / all
|
0 / 26 |
0 / 17 |
0 / 32 |
0 / 26 |
deaths causally related to treatment / all
|
0 / 16 |
0 / 11 |
0 / 21 |
0 / 16 |
Septic shock
|
|
|
|
|
subjects affected / exposed
|
11 / 6950 (0.16%) |
14 / 6950 (0.20%) |
11 / 8758 (0.13%) |
16 / 8773 (0.18%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 14 |
0 / 11 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 10 |
0 / 12 |
0 / 10 |
0 / 13 |
Sinusitis
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Soft tissue infection
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal infection
|
|
|
|
|
subjects affected / exposed
|
4 / 6950 (0.06%) |
1 / 6950 (0.01%) |
5 / 8758 (0.06%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
Staphylococcal osteomyelitis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal sepsis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Streptococcal sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Superinfection
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Testicular abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tonsillitis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tooth abscess
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tuberculosis
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Upper respiratory tract infection
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
3 / 6950 (0.04%) |
0 / 8758 (0.00%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Upper respiratory tract infection bacterial
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urethritis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
|
|
subjects affected / exposed
|
28 / 6950 (0.40%) |
24 / 6950 (0.35%) |
33 / 8758 (0.38%) |
30 / 8773 (0.34%) |
occurrences causally related to treatment / all
|
0 / 28 |
0 / 24 |
0 / 33 |
0 / 30 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 6 |
0 / 4 |
0 / 6 |
Urinary tract infection bacterial
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
2 / 8758 (0.02%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
|
|
subjects affected / exposed
|
7 / 6950 (0.10%) |
9 / 6950 (0.13%) |
8 / 8758 (0.09%) |
9 / 8773 (0.10%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 9 |
0 / 8 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 1 |
0 / 3 |
Vestibular neuronitis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
3 / 6950 (0.04%) |
0 / 8758 (0.00%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Viral infection
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
2 / 6950 (0.03%) |
2 / 8758 (0.02%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Viral sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vulvitis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wound infection
|
|
|
|
|
subjects affected / exposed
|
3 / 6950 (0.04%) |
2 / 6950 (0.03%) |
3 / 8758 (0.03%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
|
|
Cachexia
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
2 / 6950 (0.03%) |
2 / 8758 (0.02%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
Decreased appetite
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dehydration
|
|
|
|
|
subjects affected / exposed
|
8 / 6950 (0.12%) |
8 / 6950 (0.12%) |
12 / 8758 (0.14%) |
10 / 8773 (0.11%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 8 |
0 / 12 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
Diabetes mellitus
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
3 / 6950 (0.04%) |
2 / 8758 (0.02%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetes mellitus inadequate control
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic ketoacidosis
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Electrolyte imbalance
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
1 / 8758 (0.01%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Failure to thrive
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
0 / 8758 (0.00%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
Gout
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
0 / 6950 (0.00%) |
3 / 8758 (0.03%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypercholesterolaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
2 / 6950 (0.03%) |
1 / 8758 (0.01%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
2 / 6950 (0.03%) |
1 / 8758 (0.01%) |
2 / 8773 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Hyperlipidaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
1 / 6950 (0.01%) |
3 / 8758 (0.03%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypocalcaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
|
|
subjects affected / exposed
|
6 / 6950 (0.09%) |
4 / 6950 (0.06%) |
6 / 8758 (0.07%) |
4 / 8773 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
|
|
subjects affected / exposed
|
7 / 6950 (0.10%) |
2 / 6950 (0.03%) |
9 / 8758 (0.10%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 2 |
0 / 9 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
|
|
subjects affected / exposed
|
2 / 6950 (0.03%) |
5 / 6950 (0.07%) |
3 / 8758 (0.03%) |
7 / 8773 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypophagia
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
0 / 6950 (0.00%) |
1 / 8758 (0.01%) |
0 / 8773 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypovolaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Ketoacidosis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lactic acidosis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malnutrition
|
|
|
|
|
subjects affected / exposed
|
1 / 6950 (0.01%) |
2 / 6950 (0.03%) |
1 / 8758 (0.01%) |
3 / 8773 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
Marasmus
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Metabolic acidosis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
0 / 6950 (0.00%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Type 2 diabetes mellitus
|
|
|
|
|
subjects affected / exposed
|
5 / 6950 (0.07%) |
6 / 6950 (0.09%) |
6 / 8758 (0.07%) |
9 / 8773 (0.10%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
0 / 6 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Uraemic acidosis
|
|
|
|
|
subjects affected / exposed
|
0 / 6950 (0.00%) |
1 / 6950 (0.01%) |
0 / 8758 (0.00%) |
1 / 8773 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |