Serious adverse events
|
Ticagrelor |
Placebo |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
3049 / 9562 (31.89%) |
3210 / 9531 (33.68%) |
number of deaths (all causes)
|
187 |
223 |
number of deaths resulting from adverse events
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Abdominal neoplasm
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute myeloid leukaemia
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Acute promyelocytic leukaemia
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma gastric
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma of colon
|
|
|
subjects affected / exposed
|
14 / 9562 (0.15%) |
6 / 9531 (0.06%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma pancreas
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Adrenal adenoma
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adrenal neoplasm
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal cancer
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
B-cell lymphoma
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basal cell carcinoma
|
|
|
subjects affected / exposed
|
5 / 9562 (0.05%) |
9 / 9531 (0.09%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign gastric neoplasm
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign neoplasm of bladder
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign neoplasm of thyroid gland
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign ovarian tumour
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct cancer
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Bladder cancer
|
|
|
subjects affected / exposed
|
8 / 9562 (0.08%) |
9 / 9531 (0.09%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Bladder cancer recurrent
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder neoplasm
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bowen's disease
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain neoplasm
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Brain neoplasm malignant
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Breast cancer
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer female
|
|
|
subjects affected / exposed
|
9 / 9562 (0.09%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
Breast cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Breast neoplasm
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchial carcinoma
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Carcinoid tumour
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebellopontine angle tumour
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervix carcinoma recurrent
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cervix carcinoma stage 0
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangiocarcinoma
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Cholesteatoma
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chordoma
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic lymphocytic leukaemia
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic myeloid leukaemia
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Clear cell renal cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon adenoma
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon cancer
|
|
|
subjects affected / exposed
|
12 / 9562 (0.13%) |
16 / 9531 (0.17%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Colon cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Colon neoplasm
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colorectal adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colorectal cancer
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cutaneous lymphoma
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial cancer
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fibroadenoma of breast
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fibrosarcoma
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fibrous histiocytoma
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder adenocarcinoma
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder adenoma
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder cancer
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder neoplasm
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Gastric adenoma
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric cancer
|
|
|
subjects affected / exposed
|
7 / 9562 (0.07%) |
10 / 9531 (0.10%) |
occurrences causally related to treatment / all
|
1 / 7 |
1 / 10 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 3 |
Gastric neoplasm
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal carcinoma
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal lymphoma
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal melanoma
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Gastrointestinal neoplasm
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Gastrointestinal stromal tumour
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal tract adenoma
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glioblastoma
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hepatic cancer
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Hepatic cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hepatobiliary neoplasm
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hepatocellular carcinoma
|
|
|
subjects affected / exposed
|
9 / 9562 (0.09%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
Invasive breast carcinoma
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Invasive ductal breast carcinoma
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine benign neoplasm
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal cancer
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal neoplasm
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lentigo maligna
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukaemia
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lip and/or oral cavity cancer
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lip neoplasm malignant stage unspecified
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lipofibroma
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lipoma
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
6 / 9531 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lung cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Lung neoplasm
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung neoplasm malignant
|
|
|
subjects affected / exposed
|
14 / 9562 (0.15%) |
20 / 9531 (0.21%) |
occurrences causally related to treatment / all
|
0 / 14 |
1 / 20 |
deaths causally related to treatment / all
|
0 / 8 |
0 / 12 |
Lymphoma
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant melanoma
|
|
|
subjects affected / exposed
|
7 / 9562 (0.07%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant neoplasm of renal pelvis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant neoplasm of unknown primary site
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningioma
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningioma benign
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to bone
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to central nervous system
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metastases to liver
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metastases to lung
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to peritoneum
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to pleura
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastatic gastric cancer
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metastatic malignant melanoma
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metastatic neoplasm
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Monoclonal gammopathy
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Muscle neoplasm
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal cancer
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myelodysplastic syndrome
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Nasopharyngeal cancer
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neoplasm
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neoplasm malignant
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Neoplasm prostate
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-small cell lung cancer
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal adenocarcinoma
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal carcinoma
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Oesophageal neoplasm
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oral neoplasm benign
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoma
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian cancer
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Ovarian fibroma
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian granulosa cell tumour
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian neoplasm
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic carcinoma
|
|
|
subjects affected / exposed
|
12 / 9562 (0.13%) |
12 / 9531 (0.13%) |
occurrences causally related to treatment / all
|
1 / 13 |
1 / 12 |
deaths causally related to treatment / all
|
0 / 8 |
1 / 7 |
Pancreatic carcinoma metastatic
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Pancreatic neoplasm
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Pancreatic neuroendocrine tumour
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic sarcoma
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Papillary cystadenoma lymphomatosum
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Papillary thyroid cancer
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parathyroid tumour benign
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Penis carcinoma metastatic
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Phyllodes tumour
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pituitary tumour
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pituitary tumour benign
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Plasma cell myeloma
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Plasmacytoma
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleomorphic liposarcoma
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural neoplasm
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
Prostate cancer
|
|
|
subjects affected / exposed
|
31 / 9562 (0.32%) |
36 / 9531 (0.38%) |
occurrences causally related to treatment / all
|
0 / 31 |
0 / 36 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Prostate cancer metastatic
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
Prostate cancer recurrent
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Prostate cancer stage 0
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatic adenoma
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal adenocarcinoma
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal cancer
|
|
|
subjects affected / exposed
|
9 / 9562 (0.09%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
1 / 9 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal cancer recurrent
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal neoplasm
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectosigmoid cancer
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectosigmoid cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cancer
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
7 / 9531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Renal cell carcinoma
|
|
|
subjects affected / exposed
|
5 / 9562 (0.05%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Renal neoplasm
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retroperitoneal cancer
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salivary gland adenoma
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salivary gland neoplasm
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin cancer
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small cell lung cancer
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Small cell lung cancer recurrent
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestine adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestine carcinoma
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Soft tissue sarcoma
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Squamous cell carcinoma of lung
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of skin
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the cervix
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the oral cavity
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the tongue
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid adenoma
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid cancer
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
5 / 9531 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Thyroid cancer recurrent
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid neoplasm
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tongue neoplasm malignant stage unspecified
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tonsil cancer
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transitional cell cancer of the renal pelvis and ureter
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transitional cell carcinoma
|
|
|
subjects affected / exposed
|
4 / 9562 (0.04%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tumour haemorrhage
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine cancer
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine leiomyoma
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vulval cancer
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
B-cell lymphoma stage I
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma stage II
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial cancer stage I
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial cancer stage II
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Malignant neoplasm papilla of Vater
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-Hodgkin's lymphoma
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer stage III
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
Accelerated hypertension
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Air embolism
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angiopathy
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic aneurysm
|
|
|
subjects affected / exposed
|
8 / 9562 (0.08%) |
9 / 9531 (0.09%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic arteriosclerosis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic dissection
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic stenosis
|
|
|
subjects affected / exposed
|
5 / 9562 (0.05%) |
7 / 9531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial occlusive disease
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial stenosis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial thrombosis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriosclerosis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Artery dissection
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atherosclerotic plaque rupture
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood pressure inadequately controlled
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Circulatory collapse
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Deep vein thrombosis
|
|
|
subjects affected / exposed
|
6 / 9562 (0.06%) |
8 / 9531 (0.08%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic vascular disorder
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolism arterial
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolism venous
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extremity necrosis
|
|
|
subjects affected / exposed
|
5 / 9562 (0.05%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertension
|
|
|
subjects affected / exposed
|
36 / 9562 (0.38%) |
45 / 9531 (0.47%) |
occurrences causally related to treatment / all
|
0 / 40 |
0 / 45 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive crisis
|
|
|
subjects affected / exposed
|
15 / 9562 (0.16%) |
23 / 9531 (0.24%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 25 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive emergency
|
|
|
subjects affected / exposed
|
4 / 9562 (0.04%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypotension
|
|
|
subjects affected / exposed
|
9 / 9562 (0.09%) |
6 / 9531 (0.06%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypovolaemic shock
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iliac artery disease
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iliac artery embolism
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intermittent claudication
|
|
|
subjects affected / exposed
|
9 / 9562 (0.09%) |
7 / 9531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Labile blood pressure
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphocele
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphoedema
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant hypertension
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Necrosis ischaemic
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neurogenic shock
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orthostatic hypotension
|
|
|
subjects affected / exposed
|
7 / 9562 (0.07%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral arterial occlusive disease
|
|
|
subjects affected / exposed
|
31 / 9562 (0.32%) |
48 / 9531 (0.50%) |
occurrences causally related to treatment / all
|
0 / 38 |
0 / 60 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery aneurysm
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery occlusion
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery stenosis
|
|
|
subjects affected / exposed
|
10 / 9562 (0.10%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery thrombosis
|
|
|
subjects affected / exposed
|
5 / 9562 (0.05%) |
6 / 9531 (0.06%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral coldness
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral embolism
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral ischaemia
|
|
|
subjects affected / exposed
|
14 / 9562 (0.15%) |
18 / 9531 (0.19%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral vascular disorder
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
5 / 9531 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral venous disease
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rheumatoid vasculitis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shock
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Shock haemorrhagic
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subclavian artery stenosis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subgaleal haematoma
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Temporal arteritis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombophlebitis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombophlebitis superficial
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombosis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varicose vein
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular compression
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular occlusion
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous thrombosis limb
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
Administration site phlebitis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asthenia
|
|
|
subjects affected / exposed
|
4 / 9562 (0.04%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Capsular contracture associated with breast implant
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac death
|
|
|
subjects affected / exposed
|
4 / 9562 (0.04%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 1 |
Catheter site haemorrhage
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest discomfort
|
|
|
subjects affected / exposed
|
5 / 9562 (0.05%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest pain
|
|
|
subjects affected / exposed
|
6 / 9562 (0.06%) |
11 / 9531 (0.12%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Complication associated with device
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Death
|
|
|
subjects affected / exposed
|
52 / 9562 (0.54%) |
60 / 9531 (0.63%) |
occurrences causally related to treatment / all
|
0 / 52 |
1 / 60 |
deaths causally related to treatment / all
|
0 / 52 |
1 / 60 |
Drowning
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Facial pain
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fatigue
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foreign body reaction
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gait disturbance
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gait inability
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General physical health deterioration
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Impaired healing
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medical device site haemorrhage
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mucosal exfoliation
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple organ dysfunction syndrome
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Necrobiosis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Necrosis
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nodule
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-cardiac chest pain
|
|
|
subjects affected / exposed
|
54 / 9562 (0.56%) |
66 / 9531 (0.69%) |
occurrences causally related to treatment / all
|
0 / 60 |
0 / 72 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pacemaker generated arrhythmia
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral swelling
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
subjects affected / exposed
|
8 / 9562 (0.08%) |
6 / 9531 (0.06%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden cardiac death
|
|
|
subjects affected / exposed
|
6 / 9562 (0.06%) |
8 / 9531 (0.08%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 8 |
deaths causally related to treatment / all
|
1 / 6 |
0 / 8 |
Sudden death
|
|
|
subjects affected / exposed
|
5 / 9562 (0.05%) |
5 / 9531 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 5 |
Ulcer haemorrhage
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular stent occlusion
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular stent stenosis
|
|
|
subjects affected / exposed
|
6 / 9562 (0.06%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
Allergy to arthropod bite
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaphylactic reaction
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaphylactic shock
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Contrast media allergy
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug hypersensitivity
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemophagocytic lymphohistiocytosis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sarcoidosis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transplant rejection
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
Acquired hydrocele
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acquired phimosis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign prostatic hyperplasia
|
|
|
subjects affected / exposed
|
26 / 9562 (0.27%) |
21 / 9531 (0.22%) |
occurrences causally related to treatment / all
|
1 / 26 |
0 / 21 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast mass
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical dysplasia
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervix disorder
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystocele
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial atrophy
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial hyperplasia
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Genital haemorrhage
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gynaecomastia
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian cyst
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postmenopausal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatic fibrosis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatic haemorrhage
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatic obstruction
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatism
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatitis
|
|
|
subjects affected / exposed
|
7 / 9562 (0.07%) |
5 / 9531 (0.05%) |
occurrences causally related to treatment / all
|
2 / 7 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatomegaly
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine fibrosis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine haemorrhage
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine polyp
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine prolapse
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal prolapse
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
Acute pulmonary oedema
|
|
|
subjects affected / exposed
|
6 / 9562 (0.06%) |
7 / 9531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Acute respiratory distress syndrome
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Acute respiratory failure
|
|
|
subjects affected / exposed
|
11 / 9562 (0.12%) |
7 / 9531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Aspiration
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Asthma
|
|
|
subjects affected / exposed
|
14 / 9562 (0.15%) |
7 / 9531 (0.07%) |
occurrences causally related to treatment / all
|
1 / 18 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asthmatic crisis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchial disorder
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchial obstruction
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchiectasis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis chronic
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchospasm
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Choking
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic obstructive pulmonary disease
|
|
|
subjects affected / exposed
|
27 / 9562 (0.28%) |
41 / 9531 (0.43%) |
occurrences causally related to treatment / all
|
0 / 41 |
3 / 57 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Chronic respiratory failure
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diaphragmatic paralysis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
subjects affected / exposed
|
35 / 9562 (0.37%) |
29 / 9531 (0.30%) |
occurrences causally related to treatment / all
|
9 / 36 |
4 / 29 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Dyspnoea exertional
|
|
|
subjects affected / exposed
|
5 / 9562 (0.05%) |
8 / 9531 (0.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
1 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Emphysema
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epiglottic cyst
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
subjects affected / exposed
|
20 / 9562 (0.21%) |
11 / 9531 (0.12%) |
occurrences causally related to treatment / all
|
16 / 20 |
9 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemoptysis
|
|
|
subjects affected / exposed
|
4 / 9562 (0.04%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
2 / 4 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemothorax
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrothorax
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Idiopathic interstitial pneumonia
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Idiopathic pulmonary fibrosis
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Interstitial lung disease
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Laryngeal oedema
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung disorder
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung infiltration
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mediastinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal polyps
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal septum deviation
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obstructive airways disorder
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Organising pneumonia
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orthopnoea
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paranasal cyst
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
5 / 9531 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleurisy
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia aspiration
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pneumonitis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumothorax
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumothorax spontaneous
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary arterial hypertension
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary congestion
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
subjects affected / exposed
|
16 / 9562 (0.17%) |
19 / 9531 (0.20%) |
occurrences causally related to treatment / all
|
0 / 16 |
1 / 19 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
Pulmonary fibrosis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary hypertension
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary mass
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary oedema
|
|
|
subjects affected / exposed
|
10 / 9562 (0.10%) |
5 / 9531 (0.05%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pulmonary sarcoidosis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary toxicity
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory alkalosis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory arrest
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory disorder
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory failure
|
|
|
subjects affected / exposed
|
8 / 9562 (0.08%) |
8 / 9531 (0.08%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Restrictive pulmonary disease
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus congestion
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sleep apnoea syndrome
|
|
|
subjects affected / exposed
|
4 / 9562 (0.04%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
Adjustment disorder
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Affective disorder
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anxiety
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bipolar disorder
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Borderline personality disorder
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Completed suicide
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Confusional state
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Delirium
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Delirium tremens
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depression
|
|
|
subjects affected / exposed
|
6 / 9562 (0.06%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depression suicidal
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Disorientation
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Illness anxiety disorder
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Insomnia
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Major depression
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental disorder
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental status changes
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropsychiatric symptoms
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suicide attempt
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Product issues
|
|
|
Device dislocation
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device failure
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device loosening
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device malfunction
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Device occlusion
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigations
|
|
|
Alanine aminotransferase increased
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile output decreased
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood follicle stimulating hormone increased
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood glucose fluctuation
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood glucose increased
|
|
|
subjects affected / exposed
|
5 / 9562 (0.05%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood lactic acid increased
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood potassium increased
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood pressure increased
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood urine present
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac stress test abnormal
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrocardiogram abnormal
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glycosylated haemoglobin increased
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemoglobin decreased
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heart rate irregular
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic enzyme increased
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Occult blood positive
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oxygen saturation decreased
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatic specific antigen increased
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Troponin increased
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Weight decreased
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
White blood cell count decreased
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrocardiogram QRS complex prolonged
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrocardiogram ST segment depression
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis B surface antigen positive
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
Abdominal injury
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Accident at home
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acetabulum fracture
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adrenal gland injury
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia postoperative
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anastomotic leak
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anastomotic stenosis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ankle fracture
|
|
|
subjects affected / exposed
|
8 / 9562 (0.08%) |
8 / 9531 (0.08%) |
occurrences causally related to treatment / all
|
0 / 8 |
1 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial bypass thrombosis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthropod bite
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Avulsion fracture
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain contusion
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Burns third degree
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carbon monoxide poisoning
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery restenosis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract traumatic
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical vertebral fracture
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clavicle fracture
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Concussion
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Contusion
|
|
|
subjects affected / exposed
|
7 / 9562 (0.07%) |
7 / 9531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery restenosis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary vascular graft occlusion
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary vascular graft stenosis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Craniocerebral injury
|
|
|
subjects affected / exposed
|
5 / 9562 (0.05%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Dislocation of sternum
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epidural haemorrhage
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extradural haematoma
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extraskeletal ossification
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial bones fracture
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Failure to anastomose
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fall
|
|
|
subjects affected / exposed
|
5 / 9562 (0.05%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral neck fracture
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
subjects affected / exposed
|
8 / 9562 (0.08%) |
15 / 9531 (0.16%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fibula fracture
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot fracture
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foreign body
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foreign body in gastrointestinal tract
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fracture
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fractured sacrum
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hand fracture
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Head injury
|
|
|
subjects affected / exposed
|
8 / 9562 (0.08%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Heat stroke
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hip fracture
|
|
|
subjects affected / exposed
|
8 / 9562 (0.08%) |
9 / 9531 (0.09%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Humerus fracture
|
|
|
subjects affected / exposed
|
12 / 9562 (0.13%) |
8 / 9531 (0.08%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyphaema
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incisional hernia
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc injury
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint dislocation
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint injury
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament injury
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament rupture
|
|
|
subjects affected / exposed
|
4 / 9562 (0.04%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament sprain
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb injury
|
|
|
subjects affected / exposed
|
12 / 9562 (0.13%) |
7 / 9531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 13 |
1 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower limb fracture
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar vertebral fracture
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbosacral plexus injury
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Median nerve injury
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meniscus injury
|
|
|
subjects affected / exposed
|
9 / 9562 (0.09%) |
5 / 9531 (0.05%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple fractures
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple injuries
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle injury
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle strain
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nail injury
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nerve injury
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nerve root injury
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nerve root injury lumbar
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Overdose
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Patella fracture
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic fracture
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periorbital haemorrhage
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periprocedural myocardial infarction
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Post procedural complication
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural fever
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haematoma
|
|
|
subjects affected / exposed
|
4 / 9562 (0.04%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
1 / 4 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haemorrhage
|
|
|
subjects affected / exposed
|
11 / 9562 (0.12%) |
5 / 9531 (0.05%) |
occurrences causally related to treatment / all
|
6 / 11 |
4 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative ileus
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative respiratory failure
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative thoracic procedure complication
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural complication
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural haemorrhage
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
1 / 2 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural pain
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pubis fracture
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary contusion
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radiation pneumonitis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radius fracture
|
|
|
subjects affected / exposed
|
6 / 9562 (0.06%) |
8 / 9531 (0.08%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
subjects affected / exposed
|
4 / 9562 (0.04%) |
10 / 9531 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Road traffic accident
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scapula fracture
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Seroma
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shunt malfunction
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skeletal injury
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin abrasion
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin injury
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin laceration
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
6 / 9531 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skull fracture
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skull fractured base
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal column injury
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
7 / 9531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal cord injury cervical
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal fracture
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sternal fracture
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stomal hernia
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subcutaneous haematoma
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subdural haematoma
|
|
|
subjects affected / exposed
|
23 / 9562 (0.24%) |
6 / 9531 (0.06%) |
occurrences causally related to treatment / all
|
12 / 23 |
3 / 6 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Subdural haemorrhage
|
|
|
subjects affected / exposed
|
8 / 9562 (0.08%) |
5 / 9531 (0.05%) |
occurrences causally related to treatment / all
|
3 / 8 |
3 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
2 / 2 |
Tendon injury
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tendon rupture
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
8 / 9531 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thermal burn
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Thoracic vertebral fracture
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tibia fracture
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
6 / 9531 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxicity to various agents
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic fracture
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic haematoma
|
|
|
subjects affected / exposed
|
7 / 9562 (0.07%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
4 / 7 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic haemorrhage
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Traumatic haemothorax
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic intracranial haemorrhage
|
|
|
subjects affected / exposed
|
11 / 9562 (0.12%) |
7 / 9531 (0.07%) |
occurrences causally related to treatment / all
|
4 / 11 |
1 / 7 |
deaths causally related to treatment / all
|
1 / 2 |
0 / 0 |
Ulna fracture
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper limb fracture
|
|
|
subjects affected / exposed
|
6 / 9562 (0.06%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary retention postoperative
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular graft complication
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular graft thrombosis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular pseudoaneurysm
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound dehiscence
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound haemorrhage
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound necrosis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wrist fracture
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
Corneal dystrophy
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glucose-6-phosphate dehydrogenase deficiency
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neurofibromatosis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
Acute coronary syndrome
|
|
|
subjects affected / exposed
|
20 / 9562 (0.21%) |
22 / 9531 (0.23%) |
occurrences causally related to treatment / all
|
3 / 20 |
1 / 22 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Acute left ventricular failure
|
|
|
subjects affected / exposed
|
5 / 9562 (0.05%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Acute myocardial infarction
|
|
|
subjects affected / exposed
|
126 / 9562 (1.32%) |
197 / 9531 (2.07%) |
occurrences causally related to treatment / all
|
6 / 133 |
7 / 203 |
deaths causally related to treatment / all
|
0 / 14 |
0 / 19 |
Angina pectoris
|
|
|
subjects affected / exposed
|
200 / 9562 (2.09%) |
251 / 9531 (2.63%) |
occurrences causally related to treatment / all
|
5 / 239 |
7 / 267 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angina unstable
|
|
|
subjects affected / exposed
|
354 / 9562 (3.70%) |
405 / 9531 (4.25%) |
occurrences causally related to treatment / all
|
13 / 403 |
16 / 449 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
Aortic valve disease
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve incompetence
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve stenosis
|
|
|
subjects affected / exposed
|
8 / 9562 (0.08%) |
14 / 9531 (0.15%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arrhythmia
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Arteriosclerosis coronary artery
|
|
|
subjects affected / exposed
|
9 / 9562 (0.09%) |
8 / 9531 (0.08%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Atrial fibrillation
|
|
|
subjects affected / exposed
|
82 / 9562 (0.86%) |
76 / 9531 (0.80%) |
occurrences causally related to treatment / all
|
0 / 84 |
3 / 80 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial flutter
|
|
|
subjects affected / exposed
|
12 / 9562 (0.13%) |
13 / 9531 (0.14%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial tachycardia
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial thrombosis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block complete
|
|
|
subjects affected / exposed
|
16 / 9562 (0.17%) |
18 / 9531 (0.19%) |
occurrences causally related to treatment / all
|
3 / 16 |
2 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block first degree
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block second degree
|
|
|
subjects affected / exposed
|
12 / 9562 (0.13%) |
6 / 9531 (0.06%) |
occurrences causally related to treatment / all
|
1 / 12 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bifascicular block
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradyarrhythmia
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
subjects affected / exposed
|
15 / 9562 (0.16%) |
6 / 9531 (0.06%) |
occurrences causally related to treatment / all
|
2 / 15 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bundle branch block left
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bundle branch block right
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac arrest
|
|
|
subjects affected / exposed
|
7 / 9562 (0.07%) |
12 / 9531 (0.13%) |
occurrences causally related to treatment / all
|
1 / 7 |
1 / 12 |
deaths causally related to treatment / all
|
1 / 6 |
1 / 9 |
Cardiac disorder
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure
|
|
|
subjects affected / exposed
|
64 / 9562 (0.67%) |
87 / 9531 (0.91%) |
occurrences causally related to treatment / all
|
2 / 84 |
0 / 108 |
deaths causally related to treatment / all
|
0 / 11 |
0 / 9 |
Cardiac failure acute
|
|
|
subjects affected / exposed
|
20 / 9562 (0.21%) |
14 / 9531 (0.15%) |
occurrences causally related to treatment / all
|
6 / 27 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 4 |
Cardiac failure chronic
|
|
|
subjects affected / exposed
|
18 / 9562 (0.19%) |
30 / 9531 (0.31%) |
occurrences causally related to treatment / all
|
0 / 19 |
1 / 44 |
deaths causally related to treatment / all
|
0 / 1 |
1 / 2 |
Cardiac failure congestive
|
|
|
subjects affected / exposed
|
60 / 9562 (0.63%) |
47 / 9531 (0.49%) |
occurrences causally related to treatment / all
|
0 / 71 |
2 / 53 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 3 |
Cardiac tamponade
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Cardiac valve disease
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac ventricular scarring
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardio-respiratory arrest
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Cardiogenic shock
|
|
|
subjects affected / exposed
|
6 / 9562 (0.06%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 4 |
Cardiomyopathy
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiopulmonary failure
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Cardiovascular insufficiency
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Coronary artery disease
|
|
|
subjects affected / exposed
|
85 / 9562 (0.89%) |
90 / 9531 (0.94%) |
occurrences causally related to treatment / all
|
3 / 89 |
5 / 95 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Coronary artery insufficiency
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Coronary artery occlusion
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery stenosis
|
|
|
subjects affected / exposed
|
14 / 9562 (0.15%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dressler's syndrome
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extrasystoles
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive heart disease
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic cardiomyopathy
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Left ventricular dysfunction
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Left ventricular failure
|
|
|
subjects affected / exposed
|
7 / 9562 (0.07%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Microvascular coronary artery disease
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mitral valve incompetence
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mitral valve stenosis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocardial fibrosis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Myocardial infarction
|
|
|
subjects affected / exposed
|
41 / 9562 (0.43%) |
65 / 9531 (0.68%) |
occurrences causally related to treatment / all
|
0 / 43 |
1 / 66 |
deaths causally related to treatment / all
|
0 / 11 |
0 / 16 |
Myocardial ischaemia
|
|
|
subjects affected / exposed
|
36 / 9562 (0.38%) |
47 / 9531 (0.49%) |
occurrences causally related to treatment / all
|
1 / 37 |
0 / 50 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Myocarditis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nodal arrhythmia
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Palpitations
|
|
|
subjects affected / exposed
|
4 / 9562 (0.04%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericardial effusion
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericardial haemorrhage
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericarditis
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericarditis constrictive
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prinzmetal angina
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary valve incompetence
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Right ventricular failure
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinoatrial block
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus arrhythmia
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus bradycardia
|
|
|
subjects affected / exposed
|
7 / 9562 (0.07%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus node dysfunction
|
|
|
subjects affected / exposed
|
5 / 9562 (0.05%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus tachycardia
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stress cardiomyopathy
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Supraventricular extrasystoles
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
subjects affected / exposed
|
5 / 9562 (0.05%) |
9 / 9531 (0.09%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tricuspid valve incompetence
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular arrhythmia
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular asystole
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Ventricular extrasystoles
|
|
|
subjects affected / exposed
|
4 / 9562 (0.04%) |
7 / 9531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular fibrillation
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Ventricular tachycardia
|
|
|
subjects affected / exposed
|
10 / 9562 (0.10%) |
6 / 9531 (0.06%) |
occurrences causally related to treatment / all
|
1 / 10 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adams-Stokes syndrome
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
Ageusia
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Altered state of consciousness
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Amnesia
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ataxia
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Balance disorder
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basal ganglia haemorrhage
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basal ganglia infarction
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain hypoxia
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Brain injury
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain stem haemorrhage
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
2 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
2 / 3 |
0 / 0 |
Brain stem infarction
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain stem stroke
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid arteriosclerosis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery disease
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery occlusion
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery stenosis
|
|
|
subjects affected / exposed
|
18 / 9562 (0.19%) |
21 / 9531 (0.22%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 22 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid sinus syndrome
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carpal tunnel syndrome
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cauda equina syndrome
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebellar haemorrhage
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebellar infarction
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebellar stroke
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral arteriosclerosis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral atrophy
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral haematoma
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral haemorrhage
|
|
|
subjects affected / exposed
|
6 / 9562 (0.06%) |
6 / 9531 (0.06%) |
occurrences causally related to treatment / all
|
3 / 6 |
3 / 6 |
deaths causally related to treatment / all
|
1 / 2 |
2 / 4 |
Cerebral infarction
|
|
|
subjects affected / exposed
|
18 / 9562 (0.19%) |
27 / 9531 (0.28%) |
occurrences causally related to treatment / all
|
2 / 19 |
2 / 28 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
Cerebral ischaemia
|
|
|
subjects affected / exposed
|
7 / 9562 (0.07%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral small vessel ischaemic disease
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebrovascular accident
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
9 / 9531 (0.09%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 9 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Cerebrovascular insufficiency
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical cord compression
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical radiculopathy
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervicobrachial syndrome
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cluster headache
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cognitive disorder
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coma
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Dementia
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Diabetic coma
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic neuropathy
|
|
|
subjects affected / exposed
|
9 / 9562 (0.09%) |
13 / 9531 (0.14%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dizziness
|
|
|
subjects affected / exposed
|
14 / 9562 (0.15%) |
12 / 9531 (0.13%) |
occurrences causally related to treatment / all
|
1 / 15 |
2 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysarthria
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolic cerebral infarction
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Embolic stroke
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Encephalopathy
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
5 / 9531 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Epileptic encephalopathy
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Essential tremor
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial paralysis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Focal dyscognitive seizures
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Generalised tonic-clonic seizure
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage intracranial
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
1 / 1 |
2 / 4 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 1 |
Haemorrhagic stroke
|
|
|
subjects affected / exposed
|
10 / 9562 (0.10%) |
9 / 9531 (0.09%) |
occurrences causally related to treatment / all
|
7 / 10 |
6 / 9 |
deaths causally related to treatment / all
|
3 / 3 |
1 / 2 |
Haemorrhagic transformation stroke
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Headache
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemianopia
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemiparesis
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic encephalopathy
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrocephalus
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive encephalopathy
|
|
|
subjects affected / exposed
|
5 / 9562 (0.05%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoaesthesia
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemic coma
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemic encephalopathy
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemic seizure
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemic unconsciousness
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intracranial aneurysm
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intracranial pressure increased
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic cerebral infarction
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic stroke
|
|
|
subjects affected / exposed
|
85 / 9562 (0.89%) |
119 / 9531 (1.25%) |
occurrences causally related to treatment / all
|
1 / 88 |
0 / 127 |
deaths causally related to treatment / all
|
0 / 8 |
0 / 5 |
Lacunar infarction
|
|
|
subjects affected / exposed
|
9 / 9562 (0.09%) |
5 / 9531 (0.05%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lacunar stroke
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Loss of consciousness
|
|
|
subjects affected / exposed
|
4 / 9562 (0.04%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar radiculopathy
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbosacral radiculopathy
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic encephalopathy
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Microsleep
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Migraine
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myasthenia gravis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myelopathy
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nerve compression
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathy peripheral
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Normal pressure hydrocephalus
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paraesthesia
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paralysis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parkinson's disease
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
7 / 9531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parkinsonism
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral nerve lesion
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Petit mal epilepsy
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polyneuropathy
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post-traumatic headache
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Presyncope
|
|
|
subjects affected / exposed
|
5 / 9562 (0.05%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudoradicular syndrome
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Putamen haemorrhage
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radicular pain
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radiculopathy
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sciatica
|
|
|
subjects affected / exposed
|
4 / 9562 (0.04%) |
9 / 9531 (0.09%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sedation
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Seizure
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
6 / 9531 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal cord compression
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal epidural haematoma
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subarachnoid haemorrhage
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
1 / 2 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
Syncope
|
|
|
subjects affected / exposed
|
26 / 9562 (0.27%) |
27 / 9531 (0.28%) |
occurrences causally related to treatment / all
|
0 / 29 |
1 / 28 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tension headache
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thalamic infarction
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thalamus haemorrhage
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thoracic outlet syndrome
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxic encephalopathy
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transient global amnesia
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
subjects affected / exposed
|
39 / 9562 (0.41%) |
33 / 9531 (0.35%) |
occurrences causally related to treatment / all
|
3 / 39 |
1 / 34 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tremor
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular dementia
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Vascular encephalopathy
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebral artery dissection
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebral artery stenosis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebrobasilar insufficiency
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dementia with Lewy bodies
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
IIIrd nerve paralysis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Miller Fisher syndrome
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VIth nerve disorder
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VIth nerve paralysis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VIth nerve paresis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo CNS origin
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
Abdominal lymphadenopathy
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Agranulocytosis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia
|
|
|
subjects affected / exposed
|
20 / 9562 (0.21%) |
14 / 9531 (0.15%) |
occurrences causally related to treatment / all
|
13 / 20 |
3 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia macrocytic
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia of chronic disease
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia of malignant disease
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Deficiency anaemia
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Disseminated intravascular coagulation
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic anaemia
|
|
|
subjects affected / exposed
|
10 / 9562 (0.10%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
7 / 10 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypochromic anaemia
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune thrombocytopenic purpura
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Increased tendency to bruise
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iron deficiency anaemia
|
|
|
subjects affected / exposed
|
26 / 9562 (0.27%) |
6 / 9531 (0.06%) |
occurrences causally related to treatment / all
|
13 / 26 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukocytosis
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphadenopathy
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Microcytic anaemia
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
1 / 3 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrogenic anaemia
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutropenia
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Normochromic normocytic anaemia
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Normocytic anaemia
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Splenic infarction
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spontaneous haematoma
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
3 / 3 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spontaneous haemorrhage
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia vitamin B12 deficiency
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
Deafness
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Deafness neurosensory
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Deafness unilateral
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear pain
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eustachian tube dysfunction
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoacusis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inner ear disorder
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meniere's disease
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden hearing loss
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tinnitus
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tympanic membrane perforation
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tympanosclerosis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo
|
|
|
subjects affected / exposed
|
13 / 9562 (0.14%) |
7 / 9531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo positional
|
|
|
subjects affected / exposed
|
7 / 9562 (0.07%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vestibular disorder
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
Age-related macular degeneration
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aphakia
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract
|
|
|
subjects affected / exposed
|
22 / 9562 (0.23%) |
30 / 9531 (0.31%) |
occurrences causally related to treatment / all
|
0 / 26 |
1 / 35 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract cortical
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract diabetic
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract nuclear
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Corneal degeneration
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic retinopathy
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Entropion
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye haemorrhage
|
|
|
subjects affected / exposed
|
4 / 9562 (0.04%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
3 / 4 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eyelid ptosis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glaucoma
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lacrimal disorder
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Macular degeneration
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Macular fibrosis
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Macular oedema
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Macular pseudohole
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Maculopathy
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Open angle glaucoma
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Optic ischaemic neuropathy
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal artery occlusion
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal artery thrombosis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal degeneration
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal detachment
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal haemorrhage
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
5 / 9531 (0.05%) |
occurrences causally related to treatment / all
|
2 / 2 |
3 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal vein occlusion
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal vein thrombosis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinopathy
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinopathy proliferative
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rhegmatogenous retinal detachment
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Strabismus
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Trichiasis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ulcerative keratitis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Visual impairment
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitreous haemorrhage
|
|
|
subjects affected / exposed
|
9 / 9562 (0.09%) |
5 / 9531 (0.05%) |
occurrences causally related to treatment / all
|
5 / 9 |
2 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitreous opacities
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
Abdominal discomfort
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal distension
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal hernia
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
subjects affected / exposed
|
7 / 9562 (0.07%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain lower
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
5 / 9531 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal wall haematoma
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal fissure
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal fistula
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal inflammation
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis noninfective
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendix disorder
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ascites
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Barrett's oesophagus
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bezoar
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Change of bowel habit
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic gastritis
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic gastrointestinal bleeding
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coeliac disease
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis
|
|
|
subjects affected / exposed
|
4 / 9562 (0.04%) |
5 / 9531 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis ischaemic
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Constipation
|
|
|
subjects affected / exposed
|
4 / 9562 (0.04%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dental caries
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic gastroparesis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diaphragmatic hernia
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
subjects affected / exposed
|
18 / 9562 (0.19%) |
8 / 9531 (0.08%) |
occurrences causally related to treatment / all
|
1 / 18 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticular perforation
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Diverticulitis oesophageal
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum intestinal
|
|
|
subjects affected / exposed
|
4 / 9562 (0.04%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
1 / 4 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum intestinal haemorrhagic
|
|
|
subjects affected / exposed
|
5 / 9562 (0.05%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
4 / 6 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal polyp
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer
|
|
|
subjects affected / exposed
|
4 / 9562 (0.04%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
2 / 4 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
7 / 9562 (0.07%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
7 / 8 |
4 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenitis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspepsia
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysphagia
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enteritis
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocolitis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epigastric discomfort
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erosive oesophagitis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Faecaloma
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Faeces discoloured
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Food poisoning
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Functional gastrointestinal disorder
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric antral vascular ectasia
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric disorder
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric haemorrhage
|
|
|
subjects affected / exposed
|
6 / 9562 (0.06%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
5 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric polyps
|
|
|
subjects affected / exposed
|
5 / 9562 (0.05%) |
6 / 9531 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer
|
|
|
subjects affected / exposed
|
18 / 9562 (0.19%) |
9 / 9531 (0.09%) |
occurrences causally related to treatment / all
|
8 / 18 |
1 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer haemorrhage
|
|
|
subjects affected / exposed
|
6 / 9562 (0.06%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
2 / 6 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer perforation
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis
|
|
|
subjects affected / exposed
|
8 / 9562 (0.08%) |
12 / 9531 (0.13%) |
occurrences causally related to treatment / all
|
2 / 8 |
2 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis erosive
|
|
|
subjects affected / exposed
|
9 / 9562 (0.09%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
4 / 9 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis haemorrhagic
|
|
|
subjects affected / exposed
|
6 / 9562 (0.06%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
3 / 6 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroduodenal ulcer
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal angiodysplasia
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorder
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
43 / 9562 (0.45%) |
22 / 9531 (0.23%) |
occurrences causally related to treatment / all
|
30 / 44 |
18 / 23 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Gastrointestinal inflammation
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal ischaemia
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal motility disorder
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal polyp haemorrhage
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal stenosis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
2 / 3 |
2 / 2 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Gastrooesophageal reflux disease
|
|
|
subjects affected / exposed
|
5 / 9562 (0.05%) |
7 / 9531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
2 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematemesis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematochezia
|
|
|
subjects affected / exposed
|
4 / 9562 (0.04%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
3 / 4 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic erosive gastritis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
1 / 1 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoidal haemorrhage
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
2 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoids
|
|
|
subjects affected / exposed
|
5 / 9562 (0.05%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hernial eventration
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hiatus hernia
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus
|
|
|
subjects affected / exposed
|
4 / 9562 (0.04%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus paralytic
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Incarcerated inguinal hernia
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
subjects affected / exposed
|
16 / 9562 (0.17%) |
20 / 9531 (0.21%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal haemorrhage
|
|
|
subjects affected / exposed
|
6 / 9562 (0.06%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
4 / 6 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal ischaemia
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Intestinal obstruction
|
|
|
subjects affected / exposed
|
4 / 9562 (0.04%) |
5 / 9531 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal perforation
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal polyp
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal pseudo-obstruction
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal strangulation
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestinal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine perforation
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine polyp
|
|
|
subjects affected / exposed
|
18 / 9562 (0.19%) |
14 / 9531 (0.15%) |
occurrences causally related to treatment / all
|
1 / 18 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
3 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar hernia
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mechanical ileus
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Melaena
|
|
|
subjects affected / exposed
|
12 / 9562 (0.13%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
5 / 12 |
3 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nausea
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obstruction gastric
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obstructive pancreatitis
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal motility disorder
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal spasm
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal ulcer
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophagitis
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophagitis ulcerative
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic mass
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic pseudocyst
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
subjects affected / exposed
|
11 / 9562 (0.12%) |
7 / 9531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Pancreatitis acute
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
5 / 9531 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis chronic
|
|
|
subjects affected / exposed
|
4 / 9562 (0.04%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatolithiasis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peptic ulcer
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peptic ulcer haemorrhage
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periodontal disease
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritoneal adhesions
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritoneal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Proctitis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal haemorrhage
|
|
|
subjects affected / exposed
|
13 / 9562 (0.14%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
11 / 13 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal polyp
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal prolapse
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reflux gastritis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salivary gland calculus
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal haemorrhage
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subileus
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Swollen tongue
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tooth disorder
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tooth socket haemorrhage
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ulcerative gastritis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Umbilical hernia
|
|
|
subjects affected / exposed
|
4 / 9562 (0.04%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Umbilical hernia, obstructive
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
22 / 9562 (0.23%) |
10 / 9531 (0.10%) |
occurrences causally related to treatment / all
|
17 / 23 |
7 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varices oesophageal
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vomiting
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mallory-Weiss syndrome
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
2 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
Acute hepatic failure
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct obstruction
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Bile duct stone
|
|
|
subjects affected / exposed
|
7 / 9562 (0.07%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary colic
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary dyskinesia
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cholangitis acute
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis chronic
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
subjects affected / exposed
|
13 / 9562 (0.14%) |
23 / 9531 (0.24%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 27 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis acute
|
|
|
subjects affected / exposed
|
19 / 9562 (0.20%) |
14 / 9531 (0.15%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis chronic
|
|
|
subjects affected / exposed
|
5 / 9562 (0.05%) |
6 / 9531 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cholelithiasis
|
|
|
subjects affected / exposed
|
23 / 9562 (0.24%) |
25 / 9531 (0.26%) |
occurrences causally related to treatment / all
|
0 / 24 |
0 / 25 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholestasis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic hepatitis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cirrhosis alcoholic
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Drug-induced liver injury
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder disorder
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic cirrhosis
|
|
|
subjects affected / exposed
|
4 / 9562 (0.04%) |
7 / 9531 (0.07%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hepatic failure
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic function abnormal
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis acute
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jaundice
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jaundice cholestatic
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver injury
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-alcoholic steatohepatitis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Portal vein thrombosis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Steatohepatitis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
Actinic elastosis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angioedema
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Decubitus ulcer
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermal cyst
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic foot
|
|
|
subjects affected / exposed
|
29 / 9562 (0.30%) |
18 / 9531 (0.19%) |
occurrences causally related to treatment / all
|
0 / 32 |
0 / 25 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic ulcer
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ecchymosis
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eczema
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intertrigo
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic skin ulcer
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lichen planus
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myxoid cyst
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Necrobiosis lipoidica diabeticorum
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Petechiae
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prurigo
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psoriasis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rash
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin exfoliation
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin mass
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin necrosis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin ulcer
|
|
|
subjects affected / exposed
|
7 / 9562 (0.07%) |
12 / 9531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxic skin eruption
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urticaria
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Henoch-Schonlein purpura
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stevens-Johnson syndrome
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
Acute kidney injury
|
|
|
subjects affected / exposed
|
56 / 9562 (0.59%) |
39 / 9531 (0.41%) |
occurrences causally related to treatment / all
|
2 / 59 |
2 / 43 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Azotaemia
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder neck obstruction
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder neck sclerosis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder outlet obstruction
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder tamponade
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus bladder
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
7 / 9531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus urethral
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus urinary
|
|
|
subjects affected / exposed
|
6 / 9562 (0.06%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic kidney disease
|
|
|
subjects affected / exposed
|
9 / 9562 (0.09%) |
15 / 9531 (0.16%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cystitis haemorrhagic
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic nephropathy
|
|
|
subjects affected / exposed
|
6 / 9562 (0.06%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysuria
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
End stage renal disease
|
|
|
subjects affected / exposed
|
4 / 9562 (0.04%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Glomerulonephritis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glomerulosclerosis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematuria
|
|
|
subjects affected / exposed
|
32 / 9562 (0.33%) |
13 / 9531 (0.14%) |
occurrences causally related to treatment / all
|
16 / 33 |
8 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage urinary tract
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
subjects affected / exposed
|
4 / 9562 (0.04%) |
7 / 9531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive nephropathy
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Micturition disorder
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephritic syndrome
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
subjects affected / exposed
|
16 / 9562 (0.17%) |
21 / 9531 (0.22%) |
occurrences causally related to treatment / all
|
1 / 19 |
1 / 24 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephropathy toxic
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrotic syndrome
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvi-ureteric obstruction
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perinephritis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Proteinuria
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal artery arteriosclerosis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal artery occlusion
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal artery stenosis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal colic
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cyst
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal disorder
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal failure
|
|
|
subjects affected / exposed
|
16 / 9562 (0.17%) |
15 / 9531 (0.16%) |
occurrences causally related to treatment / all
|
2 / 17 |
2 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Renal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal hypertension
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal impairment
|
|
|
subjects affected / exposed
|
10 / 9562 (0.10%) |
8 / 9531 (0.08%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal injury
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal mass
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stress urinary incontinence
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tubulointerstitial nephritis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureteric stenosis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureterolithiasis
|
|
|
subjects affected / exposed
|
18 / 9562 (0.19%) |
13 / 9531 (0.14%) |
occurrences causally related to treatment / all
|
1 / 20 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral haemorrhage
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral stenosis
|
|
|
subjects affected / exposed
|
5 / 9562 (0.05%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary bladder polyp
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary incontinence
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary retention
|
|
|
subjects affected / exposed
|
4 / 9562 (0.04%) |
7 / 9531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract obstruction
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
Adrenal insufficiency
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Goitre
|
|
|
subjects affected / exposed
|
5 / 9562 (0.05%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperparathyroidism
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperparathyroidism primary
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperthyroidism
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypothyroidism
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroiditis subacute
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
Arthralgia
|
|
|
subjects affected / exposed
|
5 / 9562 (0.05%) |
6 / 9531 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis
|
|
|
subjects affected / exposed
|
4 / 9562 (0.04%) |
5 / 9531 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis reactive
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthropathy
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Back pain
|
|
|
subjects affected / exposed
|
10 / 9562 (0.10%) |
14 / 9531 (0.15%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone pain
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bursitis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical spinal stenosis
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest wall mass
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chondromalacia
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Compartment syndrome
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Costochondritis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Crystal arthropathy
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic amyotrophy
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dupuytren's contracture
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial asymmetry
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fistula
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Flank pain
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot deformity
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gouty arthritis
|
|
|
subjects affected / exposed
|
4 / 9562 (0.04%) |
5 / 9531 (0.05%) |
occurrences causally related to treatment / all
|
1 / 4 |
2 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gouty tophus
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal mass
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc degeneration
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc disorder
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
subjects affected / exposed
|
16 / 9562 (0.17%) |
19 / 9531 (0.20%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc space narrowing
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint contracture
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint swelling
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Loose body in joint
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar spinal stenosis
|
|
|
subjects affected / exposed
|
13 / 9562 (0.14%) |
7 / 9531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meniscal degeneration
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle disorder
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscular weakness
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal chest pain
|
|
|
subjects affected / exposed
|
9 / 9562 (0.09%) |
15 / 9531 (0.16%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal pain
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
9 / 9531 (0.09%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myalgia
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myofascitis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myopathy
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myositis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neck pain
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathic arthropathy
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
subjects affected / exposed
|
47 / 9562 (0.49%) |
55 / 9531 (0.58%) |
occurrences causally related to treatment / all
|
1 / 51 |
1 / 57 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteochondrosis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteonecrosis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteopenia
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoporosis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoporotic fracture
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteorrhagia
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
subjects affected / exposed
|
4 / 9562 (0.04%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Patellofemoral pain syndrome
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pathological fracture
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periarthritis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polymyalgia rheumatica
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudarthrosis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psoriatic arthropathy
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rhabdomyolysis
|
|
|
subjects affected / exposed
|
6 / 9562 (0.06%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rheumatoid arthritis
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rotator cuff syndrome
|
|
|
subjects affected / exposed
|
5 / 9562 (0.05%) |
8 / 9531 (0.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sacroiliitis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scoliosis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Seronegative arthritis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sjogren's syndrome
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Soft tissue disorder
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal column stenosis
|
|
|
subjects affected / exposed
|
8 / 9562 (0.08%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal ligament ossification
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal osteoarthritis
|
|
|
subjects affected / exposed
|
6 / 9562 (0.06%) |
11 / 9531 (0.12%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal pain
|
|
|
subjects affected / exposed
|
5 / 9562 (0.05%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondylitis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondylolisthesis
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Synovial cyst
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tendon disorder
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tenosynovitis stenosans
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
Abdominal abscess
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal sepsis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal wall abscess
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess jaw
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess limb
|
|
|
subjects affected / exposed
|
5 / 9562 (0.05%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess neck
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acinetobacter infection
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Acute endocarditis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Acute sinusitis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal abscess
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal fistula infection
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendiceal abscess
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
subjects affected / exposed
|
13 / 9562 (0.14%) |
10 / 9531 (0.10%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis perforated
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis infective
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atypical pneumonia
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacteraemia
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial diarrhoea
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial sepsis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary sepsis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain abscess
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast abscess
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cellulitis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchiolitis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
subjects affected / exposed
|
18 / 9562 (0.19%) |
22 / 9531 (0.23%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 23 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis bacterial
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bursitis infective
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Campylobacter gastroenteritis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
subjects affected / exposed
|
35 / 9562 (0.37%) |
45 / 9531 (0.47%) |
occurrences causally related to treatment / all
|
0 / 40 |
0 / 51 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis gangrenous
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis of male external genital organ
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis infective
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis infective
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic sinusitis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium difficile colitis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium difficile infection
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Complicated appendicitis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis
|
|
|
subjects affected / exposed
|
4 / 9562 (0.04%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dacryocystitis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dengue fever
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dengue haemorrhagic fever
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Device related infection
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device related sepsis
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic foot infection
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic gangrene
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea infectious
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
subjects affected / exposed
|
11 / 9562 (0.12%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
1 / 12 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulitis intestinal haemorrhagic
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysentery
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear infection
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Emphysematous cystitis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocarditis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
5 / 9531 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 2 |
Endophthalmitis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enteritis infectious
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterobacter pneumonia
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocolitis infectious
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epididymitis
|
|
|
subjects affected / exposed
|
4 / 9562 (0.04%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epiglottitis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
subjects affected / exposed
|
12 / 9562 (0.13%) |
10 / 9531 (0.10%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia urinary tract infection
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye infection viral
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Febrile infection
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fungal infection
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gangrene
|
|
|
subjects affected / exposed
|
5 / 9562 (0.05%) |
12 / 9531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
subjects affected / exposed
|
14 / 9562 (0.15%) |
18 / 9531 (0.19%) |
occurrences causally related to treatment / all
|
1 / 15 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis bacterial
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis salmonella
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis viral
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal infection
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Genitourinary tract infection
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Graft infection
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Groin abscess
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Helicobacter gastritis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Helicobacter infection
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes ophthalmic
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes virus infection
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes zoster
|
|
|
subjects affected / exposed
|
5 / 9562 (0.05%) |
5 / 9531 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incision site abscess
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected bite
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected cyst
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected dermal cyst
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected skin ulcer
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infectious colitis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infectious pleural effusion
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infective exacerbation of bronchiectasis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infective exacerbation of chronic obstructive airways disease
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Influenza
|
|
|
subjects affected / exposed
|
8 / 9562 (0.08%) |
10 / 9531 (0.10%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Joint abscess
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Kidney infection
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Labyrinthitis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver abscess
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Localised infection
|
|
|
subjects affected / exposed
|
7 / 9562 (0.07%) |
7 / 9531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower respiratory tract infection
|
|
|
subjects affected / exposed
|
4 / 9562 (0.04%) |
5 / 9531 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ludwig angina
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung abscess
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung infection
|
|
|
subjects affected / exposed
|
10 / 9562 (0.10%) |
6 / 9531 (0.06%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Meningitis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningitis bacterial
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Meningococcal infection
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Necrotising fasciitis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutropenic sepsis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal candidiasis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ophthalmic herpes zoster
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orchitis
|
|
|
subjects affected / exposed
|
5 / 9562 (0.05%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
subjects affected / exposed
|
14 / 9562 (0.15%) |
7 / 9531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis acute
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis chronic
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Otitis media
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Otitis media acute
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Otitis media chronic
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreas infection
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Papilloma viral infection
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parainfluenzae virus infection
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parotitis
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perineal abscess
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periodontitis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periorbital cellulitis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonitis
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonitis bacterial
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonsillar abscess
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngeal abscess
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumocystis jirovecii infection
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
subjects affected / exposed
|
130 / 9562 (1.36%) |
147 / 9531 (1.54%) |
occurrences causally related to treatment / all
|
1 / 137 |
4 / 153 |
deaths causally related to treatment / all
|
0 / 9 |
0 / 10 |
Pneumonia bacterial
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia escherichia
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia influenzal
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia mycoplasmal
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia staphylococcal
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pneumonia streptococcal
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia viral
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural infection
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
3 / 9531 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural sepsis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative abscess
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative wound infection
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
7 / 9531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatic abscess
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
subjects affected / exposed
|
8 / 9562 (0.08%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pyelonephritis acute
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
12 / 9531 (0.13%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis chronic
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal abscess
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
subjects affected / exposed
|
4 / 9562 (0.04%) |
5 / 9531 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Respiratory tract infection viral
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salmonellosis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scrotal abscess
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sepsis
|
|
|
subjects affected / exposed
|
14 / 9562 (0.15%) |
20 / 9531 (0.21%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 5 |
Septic shock
|
|
|
subjects affected / exposed
|
7 / 9562 (0.07%) |
7 / 9531 (0.07%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 2 |
Sinusitis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin infection
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Soft tissue infection
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal infection
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal sepsis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Streptococcal infection
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Streptococcal sepsis
|
|
|
subjects affected / exposed
|
4 / 9562 (0.04%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subcutaneous abscess
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tonsillitis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tooth abscess
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheobronchitis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheobronchitis mycoplasmal
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tuberculosis
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tuberculosis of genitourinary system
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper respiratory tract infection
|
|
|
subjects affected / exposed
|
3 / 9562 (0.03%) |
5 / 9531 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureteritis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
subjects affected / exposed
|
33 / 9562 (0.35%) |
36 / 9531 (0.38%) |
occurrences causally related to treatment / all
|
2 / 37 |
1 / 50 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection bacterial
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
subjects affected / exposed
|
12 / 9562 (0.13%) |
10 / 9531 (0.10%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
Vestibular neuronitis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral infection
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
6 / 9531 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vulval abscess
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vulval cellulitis
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound infection
|
|
|
subjects affected / exposed
|
5 / 9562 (0.05%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute hepatitis B
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic hepatitis C
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
H1N1 influenza
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis A
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis C
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis E
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatitis Escherichia coli
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
West Nile viral infection
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
Decreased appetite
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dehydration
|
|
|
subjects affected / exposed
|
6 / 9562 (0.06%) |
5 / 9531 (0.05%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes mellitus
|
|
|
subjects affected / exposed
|
24 / 9562 (0.25%) |
42 / 9531 (0.44%) |
occurrences causally related to treatment / all
|
0 / 28 |
0 / 46 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes mellitus inadequate control
|
|
|
subjects affected / exposed
|
50 / 9562 (0.52%) |
60 / 9531 (0.63%) |
occurrences causally related to treatment / all
|
0 / 55 |
0 / 78 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Diabetic complication
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic ketoacidosis
|
|
|
subjects affected / exposed
|
10 / 9562 (0.10%) |
11 / 9531 (0.12%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Diabetic metabolic decompensation
|
|
|
subjects affected / exposed
|
9 / 9562 (0.09%) |
17 / 9531 (0.18%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Euglycaemic diabetic ketoacidosis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fluid overload
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gout
|
|
|
subjects affected / exposed
|
5 / 9562 (0.05%) |
6 / 9531 (0.06%) |
occurrences causally related to treatment / all
|
1 / 7 |
3 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypercalcaemia
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
subjects affected / exposed
|
20 / 9562 (0.21%) |
22 / 9531 (0.23%) |
occurrences causally related to treatment / all
|
0 / 21 |
0 / 24 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperglycaemic hyperosmolar nonketotic syndrome
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
subjects affected / exposed
|
5 / 9562 (0.05%) |
4 / 9531 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertriglyceridaemia
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
subjects affected / exposed
|
33 / 9562 (0.35%) |
25 / 9531 (0.26%) |
occurrences causally related to treatment / all
|
0 / 39 |
0 / 26 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hypokalaemia
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypomagnesaemia
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
subjects affected / exposed
|
5 / 9562 (0.05%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypophosphataemia
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypovolaemia
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
2 / 9531 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ketoacidosis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lactic acidosis
|
|
|
subjects affected / exposed
|
2 / 9562 (0.02%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metabolic acidosis
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obesity
|
|
|
subjects affected / exposed
|
1 / 9562 (0.01%) |
0 / 9531 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Type 2 diabetes mellitus
|
|
|
subjects affected / exposed
|
12 / 9562 (0.13%) |
19 / 9531 (0.20%) |
occurrences causally related to treatment / all
|
0 / 12 |
1 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitamin D deficiency
|
|
|
subjects affected / exposed
|
0 / 9562 (0.00%) |
1 / 9531 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |