Serious adverse events
|
Placebo |
Fluticasone furoate 100 µg |
Vilanterol 25 µg |
Fluticasone furoate/vilanterol 100/25 µg |
Total subjects affected by serious adverse events
|
|
|
|
|
subjects affected / exposed
|
918 / 4131 (22.22%) |
929 / 4157 (22.35%) |
972 / 4140 (23.48%) |
961 / 4140 (23.21%) |
number of deaths (all causes)
|
0 |
0 |
0 |
0 |
number of deaths resulting from adverse events
|
|
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
|
Acute leukaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Acute lymphocytic leukaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute myeloid leukaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Adenocarcinoma gastric
|
|
|
|
|
subjects affected / exposed
|
5 / 4131 (0.12%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
Adenocarcinoma of colon
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
2 / 4157 (0.05%) |
4 / 4140 (0.10%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Adenocarcinoma of salivary gland
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Adenocarcinoma pancreas
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Adrenal adenoma
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Angiomyolipoma
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Astrocytoma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
B-cell lymphoma
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Basal cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Benign lung neoplasm
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Benign neoplasm of adrenal gland
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Benign neoplasm of bladder
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Benign neoplasm of prostate
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bile duct cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Bladder cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
5 / 4157 (0.12%) |
1 / 4140 (0.02%) |
5 / 4140 (0.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Bladder cancer stage I, without cancer in situ
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder neoplasm
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
3 / 4131 (0.07%) |
3 / 4157 (0.07%) |
5 / 4140 (0.12%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma stage 0
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Brain neoplasm
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
3 / 4157 (0.07%) |
2 / 4140 (0.05%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Brain neoplasm malignant
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
Breast cancer
|
|
|
|
|
subjects affected / exposed
|
3 / 4131 (0.07%) |
1 / 4157 (0.02%) |
4 / 4140 (0.10%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Breast cancer in situ
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Breast cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Breast cancer stage I
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
2 / 4140 (0.05%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Brenner tumour
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchial carcinoma
|
|
|
|
|
subjects affected / exposed
|
4 / 4131 (0.10%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchioloalveolar carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Carcinoid tumour
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cervix carcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholangiocarcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Choroid melanoma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic lymphocytic leukaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic myeloid leukaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Clear cell renal cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
2 / 4140 (0.05%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colon cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
3 / 4157 (0.07%) |
5 / 4140 (0.12%) |
4 / 4140 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
Colon cancer recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Colon cancer stage IV
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Colon neoplasm
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Colorectal cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ear neoplasm malignant
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Endometrial adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Eyelid haemangioma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gallbladder cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Gastric cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
3 / 4157 (0.07%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
Gastric cancer stage I
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastric cancer stage III
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal stromal tumour
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Gastrointestinal tract adenoma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Glioblastoma
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Head and neck cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Hepatic cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Hepatic neoplasm
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatocellular carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
2 / 4157 (0.05%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Inflammatory pseudotumour
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intraductal proliferative breast lesion
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Invasive ductal breast carcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Keratoacanthoma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Laryngeal cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
2 / 4157 (0.05%) |
2 / 4140 (0.05%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Laryngeal squamous cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
2 / 4140 (0.05%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lip and/or oral cavity cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lipoma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
5 / 4131 (0.12%) |
3 / 4157 (0.07%) |
4 / 4140 (0.10%) |
4 / 4140 (0.10%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 2 |
Lung adenocarcinoma metastatic
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
Lung adenocarcinoma stage I
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
2 / 4157 (0.05%) |
2 / 4140 (0.05%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Lung adenocarcinoma stage IV
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
5 / 4157 (0.12%) |
3 / 4140 (0.07%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 3 |
0 / 1 |
Lung carcinoma cell type unspecified recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung carcinoma cell type unspecified stage 0
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung carcinoma cell type unspecified stage III
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Lung carcinoma cell type unspecified stage IV
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
Lung neoplasm
|
|
|
|
|
subjects affected / exposed
|
5 / 4131 (0.12%) |
4 / 4157 (0.10%) |
3 / 4140 (0.07%) |
4 / 4140 (0.10%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 3 |
Lung neoplasm malignant
|
|
|
|
|
subjects affected / exposed
|
8 / 4131 (0.19%) |
13 / 4157 (0.31%) |
17 / 4140 (0.41%) |
10 / 4140 (0.24%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 13 |
0 / 17 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 7 |
0 / 8 |
0 / 2 |
Lung squamous cell carcinoma metastatic
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Lung squamous cell carcinoma stage II
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung squamous cell carcinoma stage III
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung squamous cell carcinoma stage IV
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
2 / 4140 (0.05%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
Lymphangiosis carcinomatosa
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lymphocytic lymphoma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malignant melanoma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malignant neoplasm of ampulla of Vater
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malignant neoplasm of choroid
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Meningioma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Meningioma benign
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mesenteric neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mesothelioma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Metastases to adrenals
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to bone
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Metastases to bone marrow
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to central nervous system
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
2 / 4157 (0.05%) |
2 / 4140 (0.05%) |
4 / 4140 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
Metastases to liver
|
|
|
|
|
subjects affected / exposed
|
6 / 4131 (0.15%) |
2 / 4157 (0.05%) |
9 / 4140 (0.22%) |
4 / 4140 (0.10%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
0 / 9 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 5 |
0 / 2 |
Metastases to lung
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
3 / 4157 (0.07%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
Metastases to lymph nodes
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to peritoneum
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Metastases to skin
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to spine
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Metastases to spleen
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to stomach
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Metastatic malignant melanoma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastatic neoplasm
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastatic renal cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Myelodysplastic syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Myeloproliferative disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neoplasm malignant
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Neoplasm prostate
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Neuroendocrine tumour
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Non-Hodgkin's lymphoma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
2 / 4140 (0.05%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Non-small cell lung cancer
|
|
|
|
|
subjects affected / exposed
|
3 / 4131 (0.07%) |
7 / 4157 (0.17%) |
0 / 4140 (0.00%) |
4 / 4140 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 5 |
0 / 0 |
0 / 0 |
Non-small cell lung cancer stage I
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Non-small cell lung cancer stage II
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Non-small cell lung cancer stage IIIA
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Non-small cell lung cancer stage IIIB
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Oesophageal adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal carcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
2 / 4140 (0.05%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal squamous cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal squamous cell carcinoma metastatic
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal squamous cell carcinoma stage II
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Oral neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oropharyngeal squamous cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ovarian cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Ovarian germ cell teratoma benign
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ovarian granulosa cell tumour
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatic carcinoma
|
|
|
|
|
subjects affected / exposed
|
6 / 4131 (0.15%) |
1 / 4157 (0.02%) |
4 / 4140 (0.10%) |
4 / 4140 (0.10%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
0 / 2 |
Pancreatic carcinoma metastatic
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Pancreatic neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Papillary cystadenoma lymphomatosum
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Papillary thyroid cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Phyllodes tumour
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pituitary tumour benign
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Plasma cell myeloma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
2 / 4140 (0.05%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Polycythaemia vera
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prostate cancer
|
|
|
|
|
subjects affected / exposed
|
5 / 4131 (0.12%) |
4 / 4157 (0.10%) |
8 / 4140 (0.19%) |
11 / 4140 (0.27%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
0 / 8 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
Prostate cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
2 / 4140 (0.05%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Prostate cancer recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Prostatic adenoma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
2 / 4140 (0.05%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
3 / 4131 (0.07%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal adenoma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Renal cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Renal neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal oncocytoma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Retroperitoneal neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
2 / 4157 (0.05%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Round cell liposarcoma
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Schwannoma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Scrotal cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Small cell lung cancer
|
|
|
|
|
subjects affected / exposed
|
4 / 4131 (0.10%) |
3 / 4157 (0.07%) |
3 / 4140 (0.07%) |
6 / 4140 (0.14%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 4 |
Small cell lung cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
0 / 4157 (0.00%) |
2 / 4140 (0.05%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
Small intestine carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Spinal cord neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
4 / 4140 (0.10%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma of lung
|
|
|
|
|
subjects affected / exposed
|
6 / 4131 (0.15%) |
6 / 4157 (0.14%) |
5 / 4140 (0.12%) |
12 / 4140 (0.29%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
0 / 5 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 0 |
0 / 6 |
Squamous cell carcinoma of skin
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the cervix
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the oral cavity
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the tongue
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
T-cell lymphoma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Throat cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thymoma malignant
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Thyroid neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tongue neoplasm malignant stage unspecified
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tonsil cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Transitional cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
2 / 4140 (0.05%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ureteric cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Uterine cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
2 / 4157 (0.05%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Uterine leiomyoma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Uterine leiomyosarcoma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vocal cord neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vulvar adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
|
|
Aortic aneurysm
|
|
|
|
|
subjects affected / exposed
|
10 / 4131 (0.24%) |
8 / 4157 (0.19%) |
5 / 4140 (0.12%) |
4 / 4140 (0.10%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 8 |
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Aortic aneurysm rupture
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
2 / 4157 (0.05%) |
3 / 4140 (0.07%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 3 |
0 / 1 |
Aortic arteriosclerosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic dilatation
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic dissection
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
Aortic stenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
3 / 4140 (0.07%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Aortic thrombosis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arterial disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arterial occlusive disease
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arterial rupture
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arterial stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arterial thrombosis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arteriosclerosis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
2 / 4140 (0.05%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
Arteriovenous fistula
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Circulatory collapse
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
2 / 4157 (0.05%) |
0 / 4140 (0.00%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
Deep vein thrombosis
|
|
|
|
|
subjects affected / exposed
|
6 / 4131 (0.15%) |
5 / 4157 (0.12%) |
4 / 4140 (0.10%) |
5 / 4140 (0.12%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic microangiopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Embolism
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Extremity necrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Femoral artery occlusion
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
3 / 4157 (0.07%) |
3 / 4140 (0.07%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypertension
|
|
|
|
|
subjects affected / exposed
|
7 / 4131 (0.17%) |
9 / 4157 (0.22%) |
8 / 4140 (0.19%) |
11 / 4140 (0.27%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 9 |
1 / 8 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
Hypertensive crisis
|
|
|
|
|
subjects affected / exposed
|
3 / 4131 (0.07%) |
5 / 4157 (0.12%) |
5 / 4140 (0.12%) |
9 / 4140 (0.22%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Hypertensive emergency
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypotension
|
|
|
|
|
subjects affected / exposed
|
4 / 4131 (0.10%) |
8 / 4157 (0.19%) |
2 / 4140 (0.05%) |
7 / 4140 (0.17%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 9 |
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypovolaemic shock
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Iliac artery occlusion
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
2 / 4157 (0.05%) |
3 / 4140 (0.07%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intermittent claudication
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
3 / 4140 (0.07%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Leriche syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
2 / 4140 (0.05%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Orthostatic hypotension
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Penetrating atherosclerotic ulcer
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral arterial occlusive disease
|
|
|
|
|
subjects affected / exposed
|
9 / 4131 (0.22%) |
16 / 4157 (0.38%) |
11 / 4140 (0.27%) |
5 / 4140 (0.12%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 19 |
0 / 11 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery aneurysm
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery stenosis
|
|
|
|
|
subjects affected / exposed
|
4 / 4131 (0.10%) |
3 / 4157 (0.07%) |
2 / 4140 (0.05%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 7 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery thrombosis
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
3 / 4157 (0.07%) |
1 / 4140 (0.02%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral circulatory failure
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral embolism
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral ischaemia
|
|
|
|
|
subjects affected / exposed
|
4 / 4131 (0.10%) |
3 / 4157 (0.07%) |
3 / 4140 (0.07%) |
4 / 4140 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral vascular disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
8 / 4157 (0.19%) |
3 / 4140 (0.07%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 8 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral venous disease
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Phlebitis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Poor peripheral circulation
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Raynaud's phenomenon
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renovascular hypertension
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Secondary hypertension
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Shock haemorrhagic
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Subclavian artery occlusion
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subclavian artery stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subclavian steal syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Temporal arteritis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thromboangiitis obliterans
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thrombophlebitis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thrombosis
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
2 / 4157 (0.05%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Varicose vein
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular occlusion
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vasoconstriction
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Venous occlusion
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
2 / 4157 (0.05%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Venous thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Venous thrombosis limb
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vessel perforation
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
|
|
Finger amputation
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Knee arthroplasty
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rotator cuff repair
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Surgery
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
|
|
Adverse drug reaction
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Asthenia
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
2 / 4157 (0.05%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac death
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Chest discomfort
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
2 / 4140 (0.05%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chest pain
|
|
|
|
|
subjects affected / exposed
|
16 / 4131 (0.39%) |
10 / 4157 (0.24%) |
8 / 4140 (0.19%) |
16 / 4140 (0.39%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 10 |
0 / 8 |
1 / 18 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 1 |
0 / 0 |
Cyst
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Death
|
|
|
|
|
subjects affected / exposed
|
6 / 4131 (0.15%) |
7 / 4157 (0.17%) |
5 / 4140 (0.12%) |
7 / 4140 (0.17%) |
occurrences causally related to treatment / all
|
0 / 6 |
1 / 7 |
0 / 5 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 6 |
1 / 7 |
0 / 5 |
0 / 7 |
Device defective
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device deployment issue
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device dislocation
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device electrical finding
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device failure
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device issue
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device malfunction
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device occlusion
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
2 / 4157 (0.05%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Electrocution
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Fatigue
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
2 / 4157 (0.05%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gait disturbance
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Generalised oedema
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hernia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Impaired healing
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
0 / 4157 (0.00%) |
3 / 4140 (0.07%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Influenza like illness
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic ulcer
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Medical device complication
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Multi-organ failure
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
3 / 4157 (0.07%) |
2 / 4140 (0.05%) |
6 / 4140 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 1 |
0 / 5 |
Non-cardiac chest pain
|
|
|
|
|
subjects affected / exposed
|
4 / 4131 (0.10%) |
5 / 4157 (0.12%) |
10 / 4140 (0.24%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
0 / 10 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
2 / 4157 (0.05%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pain
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
0 / 4157 (0.00%) |
2 / 4140 (0.05%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sudden cardiac death
|
|
|
|
|
subjects affected / exposed
|
3 / 4131 (0.07%) |
7 / 4157 (0.17%) |
6 / 4140 (0.14%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 7 |
0 / 6 |
0 / 1 |
Sudden death
|
|
|
|
|
subjects affected / exposed
|
20 / 4131 (0.48%) |
14 / 4157 (0.34%) |
17 / 4140 (0.41%) |
20 / 4140 (0.48%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 14 |
0 / 17 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 20 |
0 / 14 |
0 / 17 |
0 / 20 |
Immune system disorders
|
|
|
|
|
Anaphylactic reaction
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anaphylactic shock
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
2 / 4157 (0.05%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Drug hypersensitivity
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
2 / 4140 (0.05%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Food allergy
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypersensitivity
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
|
|
Benign prostatic hyperplasia
|
|
|
|
|
subjects affected / exposed
|
3 / 4131 (0.07%) |
7 / 4157 (0.17%) |
3 / 4140 (0.07%) |
5 / 4140 (0.12%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 7 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Breast pain
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cervical polyp
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cervix disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Endometrial hyperplasia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fallopian tube cyst
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peyronie's disease
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prostatitis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prostatomegaly
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Uterine enlargement
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
|
Acute pulmonary oedema
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Acute respiratory distress syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute respiratory failure
|
|
|
|
|
subjects affected / exposed
|
17 / 4131 (0.41%) |
7 / 4157 (0.17%) |
8 / 4140 (0.19%) |
12 / 4140 (0.29%) |
occurrences causally related to treatment / all
|
1 / 18 |
0 / 7 |
0 / 8 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 2 |
0 / 0 |
Atelectasis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
4 / 4140 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchial polyp
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchial secretion retention
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchiectasis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchospasm
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchostenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bullous lung disease
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
2 / 4140 (0.05%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic obstructive pulmonary disease
|
|
|
|
|
subjects affected / exposed
|
262 / 4131 (6.34%) |
214 / 4157 (5.15%) |
245 / 4140 (5.92%) |
189 / 4140 (4.57%) |
occurrences causally related to treatment / all
|
10 / 356 |
7 / 274 |
7 / 326 |
6 / 237 |
deaths causally related to treatment / all
|
0 / 6 |
0 / 6 |
0 / 4 |
1 / 8 |
Chronic respiratory failure
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cough
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
|
|
subjects affected / exposed
|
6 / 4131 (0.15%) |
9 / 4157 (0.22%) |
2 / 4140 (0.05%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 9 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Dyspnoea at rest
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Emphysema
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
2 / 4157 (0.05%) |
2 / 4140 (0.05%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemoptysis
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
8 / 4157 (0.19%) |
3 / 4140 (0.07%) |
4 / 4140 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 8 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemothorax
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hydrothorax
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
3 / 4157 (0.07%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypercapnia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypoxia
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
1 / 4157 (0.02%) |
3 / 4140 (0.07%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Laryngeal disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Laryngeal polyp
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung consolidation
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Lung disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Lung infiltration
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nasal septum deviation
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nasal septum disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Organising pneumonia
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pharyngeal cyst
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pickwickian syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
|
|
subjects affected / exposed
|
6 / 4131 (0.15%) |
3 / 4157 (0.07%) |
3 / 4140 (0.07%) |
9 / 4140 (0.22%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
0 / 3 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Pleurisy
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia aspiration
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
2 / 4157 (0.05%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Pneumonitis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumothorax
|
|
|
|
|
subjects affected / exposed
|
7 / 4131 (0.17%) |
6 / 4157 (0.14%) |
4 / 4140 (0.10%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 6 |
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumothorax spontaneous
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary congestion
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
3 / 4140 (0.07%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Pulmonary embolism
|
|
|
|
|
subjects affected / exposed
|
10 / 4131 (0.24%) |
12 / 4157 (0.29%) |
17 / 4140 (0.41%) |
13 / 4140 (0.31%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 14 |
0 / 17 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 5 |
0 / 6 |
Pulmonary fibrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary hilum mass
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary hypertension
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary mass
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
2 / 4157 (0.05%) |
2 / 4140 (0.05%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary oedema
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
4 / 4157 (0.10%) |
4 / 4140 (0.10%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
Respiratory distress
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Respiratory failure
|
|
|
|
|
subjects affected / exposed
|
8 / 4131 (0.19%) |
7 / 4157 (0.17%) |
9 / 4140 (0.22%) |
9 / 4140 (0.22%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 7 |
0 / 9 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 4 |
0 / 3 |
Sinus polyp
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sleep apnoea syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vocal cord disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
|
|
Affective disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Alcohol abuse
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Alcohol withdrawal syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Alcoholism
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anxiety
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bipolar disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Completed suicide
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 0 |
Confusional state
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Delirium
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Depression
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
2 / 4157 (0.05%) |
1 / 4140 (0.02%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Drug abuse
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dysphoria
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hallucination, visual
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Insomnia
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Major depression
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mental status changes
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
3 / 4157 (0.07%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Psychogenic seizure
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Schizoaffective disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Schizophrenia, paranoid type
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Substance abuse
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Substance-induced mood disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Suicidal behaviour
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Suicidal ideation
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Investigations
|
|
|
|
|
Alanine aminotransferase increased
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arteriogram coronary
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood glucose fluctuation
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood glucose increased
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood pressure increased
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
2 / 4157 (0.05%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood urine present
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chest X-ray abnormal
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic enzyme increased
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
2 / 4157 (0.05%) |
0 / 4140 (0.00%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Liver function test abnormal
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
2 / 4140 (0.05%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myocardial necrosis marker increased
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Weight decreased
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
|
|
Accidental overdose
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acetabulum fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Alcohol poisoning
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anastomotic ulcer haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ankle fracture
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
2 / 4157 (0.05%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Brain contusion
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Burns third degree
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cataract traumatic
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cervical vertebral fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chemical burn of skin
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chemical injury
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Clavicle fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Comminuted fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Concussion
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Contusion
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
4 / 4157 (0.10%) |
4 / 4140 (0.10%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 6 |
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Coronary artery restenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coronary vascular graft occlusion
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dislocation of vertebra
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Exposure via inhalation
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Eye contusion
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Facial bones fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
2 / 4140 (0.05%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Failure to anastomose
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fall
|
|
|
|
|
subjects affected / exposed
|
4 / 4131 (0.10%) |
2 / 4157 (0.05%) |
4 / 4140 (0.10%) |
4 / 4140 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Femoral neck fracture
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
4 / 4157 (0.10%) |
2 / 4140 (0.05%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
|
|
subjects affected / exposed
|
5 / 4131 (0.12%) |
6 / 4157 (0.14%) |
5 / 4140 (0.12%) |
8 / 4140 (0.19%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 7 |
0 / 5 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Fibula fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Foot fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Forearm fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal injury
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gun shot wound
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Hand fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
2 / 4157 (0.05%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Head injury
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic haematoma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hip fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
2 / 4157 (0.05%) |
1 / 4140 (0.02%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Humerus fracture
|
|
|
|
|
subjects affected / exposed
|
3 / 4131 (0.07%) |
4 / 4157 (0.10%) |
1 / 4140 (0.02%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Incisional hernia
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal anastomosis complication
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Joint capsule rupture
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Joint dislocation
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Laceration
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ligament rupture
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
2 / 4140 (0.05%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Limb crushing injury
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Limb traumatic amputation
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lower limb fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar vertebral fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Meniscus injury
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Multiple fractures
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Multiple injuries
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Muscle injury
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Muscle rupture
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Overdose
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Patella fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
2 / 4140 (0.05%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Periorbital contusion
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Periprosthetic fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumothorax traumatic
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
2 / 4140 (0.05%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post laminectomy syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural complication
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural haematoma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural haematuria
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative hernia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative ileus
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative respiratory failure
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Procedural complication
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Procedural pain
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Radiation pneumonitis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Radius fracture
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
6 / 4140 (0.14%) |
6 / 4140 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Road traffic accident
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Scar
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Seroma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Shunt thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skull fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Soft tissue injury
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
2 / 4140 (0.05%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sternal fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subdural haematoma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Tendon rupture
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
2 / 4157 (0.05%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thoracic vertebral fracture
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tibia fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
3 / 4157 (0.07%) |
0 / 4140 (0.00%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Toxicity to various agents
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic haematoma
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic haemothorax
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic intracranial haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ulna fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Upper limb fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
2 / 4140 (0.05%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urethral injury
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
VIth nerve injury
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular graft occlusion
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular graft thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular pseudoaneurysm
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wound
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
0 / 4157 (0.00%) |
2 / 4140 (0.05%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Wound evisceration
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wrist fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
|
|
Adrenogenital syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrial septal defect
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hydrocele
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pyloric stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sturge-Weber syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vitello-intestinal duct remnant
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
|
|
Acute coronary syndrome
|
|
|
|
|
subjects affected / exposed
|
3 / 4131 (0.07%) |
3 / 4157 (0.07%) |
6 / 4140 (0.14%) |
5 / 4140 (0.12%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Acute left ventricular failure
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
2 / 4140 (0.05%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Acute myocardial infarction
|
|
|
|
|
subjects affected / exposed
|
23 / 4131 (0.56%) |
20 / 4157 (0.48%) |
21 / 4140 (0.51%) |
28 / 4140 (0.68%) |
occurrences causally related to treatment / all
|
0 / 23 |
0 / 20 |
0 / 21 |
2 / 30 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 6 |
0 / 4 |
1 / 7 |
Adams-Stokes syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Angina pectoris
|
|
|
|
|
subjects affected / exposed
|
22 / 4131 (0.53%) |
19 / 4157 (0.46%) |
20 / 4140 (0.48%) |
12 / 4140 (0.29%) |
occurrences causally related to treatment / all
|
0 / 23 |
0 / 21 |
0 / 22 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Angina unstable
|
|
|
|
|
subjects affected / exposed
|
23 / 4131 (0.56%) |
22 / 4157 (0.53%) |
16 / 4140 (0.39%) |
23 / 4140 (0.56%) |
occurrences causally related to treatment / all
|
0 / 24 |
1 / 24 |
3 / 17 |
1 / 23 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic valve disease
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic valve incompetence
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic valve stenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arrhythmia
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
4 / 4157 (0.10%) |
3 / 4140 (0.07%) |
6 / 4140 (0.14%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 4 |
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 1 |
0 / 2 |
Arrhythmia supraventricular
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arteriosclerosis coronary artery
|
|
|
|
|
subjects affected / exposed
|
3 / 4131 (0.07%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 2 |
Atrial fibrillation
|
|
|
|
|
subjects affected / exposed
|
31 / 4131 (0.75%) |
22 / 4157 (0.53%) |
30 / 4140 (0.72%) |
32 / 4140 (0.77%) |
occurrences causally related to treatment / all
|
3 / 37 |
0 / 23 |
5 / 31 |
4 / 36 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Atrial flutter
|
|
|
|
|
subjects affected / exposed
|
6 / 4131 (0.15%) |
3 / 4157 (0.07%) |
3 / 4140 (0.07%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
1 / 6 |
1 / 3 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrial tachycardia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular block
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
2 / 4157 (0.05%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
Atrioventricular block complete
|
|
|
|
|
subjects affected / exposed
|
3 / 4131 (0.07%) |
2 / 4157 (0.05%) |
3 / 4140 (0.07%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Atrioventricular block first degree
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular block second degree
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
2 / 4157 (0.05%) |
3 / 4140 (0.07%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bradyarrhythmia
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
|
|
subjects affected / exposed
|
3 / 4131 (0.07%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Bundle branch block left
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
Bundle branch block right
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac arrest
|
|
|
|
|
subjects affected / exposed
|
9 / 4131 (0.22%) |
9 / 4157 (0.22%) |
11 / 4140 (0.27%) |
4 / 4140 (0.10%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 9 |
0 / 11 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 7 |
0 / 8 |
0 / 9 |
0 / 2 |
Cardiac failure
|
|
|
|
|
subjects affected / exposed
|
28 / 4131 (0.68%) |
17 / 4157 (0.41%) |
19 / 4140 (0.46%) |
28 / 4140 (0.68%) |
occurrences causally related to treatment / all
|
0 / 30 |
0 / 18 |
0 / 23 |
1 / 31 |
deaths causally related to treatment / all
|
0 / 8 |
0 / 4 |
0 / 5 |
0 / 7 |
Cardiac failure acute
|
|
|
|
|
subjects affected / exposed
|
7 / 4131 (0.17%) |
3 / 4157 (0.07%) |
3 / 4140 (0.07%) |
7 / 4140 (0.17%) |
occurrences causally related to treatment / all
|
0 / 7 |
1 / 3 |
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 6 |
0 / 1 |
0 / 2 |
0 / 5 |
Cardiac failure chronic
|
|
|
|
|
subjects affected / exposed
|
5 / 4131 (0.12%) |
7 / 4157 (0.17%) |
4 / 4140 (0.10%) |
7 / 4140 (0.17%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
0 / 4 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 2 |
Cardiac failure congestive
|
|
|
|
|
subjects affected / exposed
|
26 / 4131 (0.63%) |
26 / 4157 (0.63%) |
21 / 4140 (0.51%) |
30 / 4140 (0.72%) |
occurrences causally related to treatment / all
|
1 / 30 |
0 / 33 |
0 / 22 |
0 / 33 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 4 |
0 / 2 |
0 / 1 |
Cardiac perforation
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac valve disease
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac ventricular thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardio-respiratory arrest
|
|
|
|
|
subjects affected / exposed
|
11 / 4131 (0.27%) |
9 / 4157 (0.22%) |
11 / 4140 (0.27%) |
5 / 4140 (0.12%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 9 |
0 / 11 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 10 |
0 / 9 |
0 / 10 |
0 / 4 |
Cardiogenic shock
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
0 / 0 |
Cardiomegaly
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiomyopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
2 / 4140 (0.05%) |
4 / 4140 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
Cardiopulmonary failure
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
3 / 4157 (0.07%) |
4 / 4140 (0.10%) |
4 / 4140 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 3 |
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
1 / 3 |
0 / 3 |
0 / 4 |
Cardiovascular disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
2 / 4157 (0.05%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
Cardiovascular insufficiency
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
2 / 4140 (0.05%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
Conduction disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Congestive cardiomyopathy
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
2 / 4157 (0.05%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 2 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Cor pulmonale
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
2 / 4157 (0.05%) |
0 / 4140 (0.00%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery disease
|
|
|
|
|
subjects affected / exposed
|
22 / 4131 (0.53%) |
14 / 4157 (0.34%) |
25 / 4140 (0.60%) |
24 / 4140 (0.58%) |
occurrences causally related to treatment / all
|
0 / 23 |
0 / 14 |
0 / 26 |
0 / 25 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 2 |
Coronary artery insufficiency
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Coronary artery occlusion
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
3 / 4140 (0.07%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery stenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
2 / 4157 (0.05%) |
1 / 4140 (0.02%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Coronary ostial stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diastolic dysfunction
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Extrasystoles
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive heart disease
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
2 / 4140 (0.05%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic cardiomyopathy
|
|
|
|
|
subjects affected / exposed
|
4 / 4131 (0.10%) |
3 / 4157 (0.07%) |
4 / 4140 (0.10%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Left ventricular dysfunction
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Left ventricular failure
|
|
|
|
|
subjects affected / exposed
|
3 / 4131 (0.07%) |
2 / 4157 (0.05%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Left ventricular hypertrophy
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
2 / 4140 (0.05%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mitral valve incompetence
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Mitral valve stenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myocardial fibrosis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Myocardial infarction
|
|
|
|
|
subjects affected / exposed
|
24 / 4131 (0.58%) |
32 / 4157 (0.77%) |
26 / 4140 (0.63%) |
24 / 4140 (0.58%) |
occurrences causally related to treatment / all
|
0 / 24 |
1 / 35 |
0 / 27 |
0 / 25 |
deaths causally related to treatment / all
|
0 / 10 |
1 / 17 |
0 / 16 |
0 / 7 |
Myocardial ischaemia
|
|
|
|
|
subjects affected / exposed
|
7 / 4131 (0.17%) |
8 / 4157 (0.19%) |
5 / 4140 (0.12%) |
7 / 4140 (0.17%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 8 |
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
Myocardial necrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myocarditis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pericardial effusion
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulseless electrical activity
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Rheumatic heart disease
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Right ventricular failure
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sinoatrial block
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sinus bradycardia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sinus node dysfunction
|
|
|
|
|
subjects affected / exposed
|
3 / 4131 (0.07%) |
2 / 4157 (0.05%) |
0 / 4140 (0.00%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sinus tachycardia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
2 / 4140 (0.05%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Supraventricular extrasystoles
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Supraventricular tachyarrhythmia
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
3 / 4140 (0.07%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
2 / 4157 (0.05%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tachycardia paroxysmal
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ventricle rupture
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular extrasystoles
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular fibrillation
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
3 / 4140 (0.07%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Ventricular tachycardia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
3 / 4157 (0.07%) |
2 / 4140 (0.05%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
|
|
Amyotrophic lateral sclerosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Aphasia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ataxia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Basal ganglia infarction
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Basilar artery occlusion
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Brain injury
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Brain mass
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Brain oedema
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
Brain stem infarction
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Brain stem ischaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Brain stem stroke
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Carotid arteriosclerosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Carotid artery aneurysm
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Carotid artery disease
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Carotid artery occlusion
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Carotid artery stenosis
|
|
|
|
|
subjects affected / exposed
|
4 / 4131 (0.10%) |
6 / 4157 (0.14%) |
4 / 4140 (0.10%) |
7 / 4140 (0.17%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Carpal tunnel syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebellar atrophy
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebellar syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral arteriosclerosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral atrophy
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral haematoma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Cerebral haemorrhage
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
0 / 4157 (0.00%) |
3 / 4140 (0.07%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral infarction
|
|
|
|
|
subjects affected / exposed
|
5 / 4131 (0.12%) |
6 / 4157 (0.14%) |
4 / 4140 (0.10%) |
7 / 4140 (0.17%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
0 / 4 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
Cerebral ischaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral ventricle dilatation
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebrospinal fluid leakage
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebrovascular accident
|
|
|
|
|
subjects affected / exposed
|
16 / 4131 (0.39%) |
11 / 4157 (0.26%) |
11 / 4140 (0.27%) |
18 / 4140 (0.43%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 11 |
0 / 11 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 8 |
0 / 2 |
0 / 3 |
0 / 6 |
Cerebrovascular disorder
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Cerebrovascular insufficiency
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
2 / 4140 (0.05%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cervical myelopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cervical radiculopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cognitive disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Complex partial seizures
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dementia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Dementia Alzheimer's type
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic neuropathy
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diplegia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dizziness
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
2 / 4157 (0.05%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Encephalopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Generalised tonic-clonic seizure
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhage intracranial
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhagic cerebral infarction
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhagic stroke
|
|
|
|
|
subjects affected / exposed
|
4 / 4131 (0.10%) |
4 / 4157 (0.10%) |
4 / 4140 (0.10%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 4 |
0 / 1 |
Headache
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hemiparesis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hemiplegia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic encephalopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypoaesthesia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypoxic-ischaemic encephalopathy
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
IIIrd nerve paralysis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intercostal neuralgia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intracranial aneurysm
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intraventricular haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Ischaemic cerebral infarction
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
0 / 4157 (0.00%) |
2 / 4140 (0.05%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Ischaemic stroke
|
|
|
|
|
subjects affected / exposed
|
19 / 4131 (0.46%) |
15 / 4157 (0.36%) |
14 / 4140 (0.34%) |
19 / 4140 (0.46%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 15 |
1 / 16 |
0 / 21 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 2 |
1 / 3 |
0 / 3 |
Lacunar infarction
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Lumbar radiculopathy
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Meralgia paraesthetica
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metabolic encephalopathy
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Migraine
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Multiple sclerosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myasthenia gravis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nerve compression
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neurological symptom
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neuropathy peripheral
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Normal pressure hydrocephalus
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Paraesthesia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Parkinson's disease
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral sensory neuropathy
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Polyneuropathy
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Postictal paralysis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Presyncope
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Radicular syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Radiculopathy
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sacral radiculopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sciatica
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Seizure
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
2 / 4157 (0.05%) |
4 / 4140 (0.10%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Speech disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal cord disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spondylitic myelopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subarachnoid haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
2 / 4157 (0.05%) |
3 / 4140 (0.07%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
Syncope
|
|
|
|
|
subjects affected / exposed
|
6 / 4131 (0.15%) |
7 / 4157 (0.17%) |
6 / 4140 (0.14%) |
10 / 4140 (0.24%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
0 / 7 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thoracic outlet syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Transient global amnesia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
|
|
subjects affected / exposed
|
7 / 4131 (0.17%) |
13 / 4157 (0.31%) |
16 / 4140 (0.39%) |
9 / 4140 (0.22%) |
occurrences causally related to treatment / all
|
0 / 7 |
1 / 13 |
0 / 16 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Trigeminal neuralgia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular encephalopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular parkinsonism
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vertebral artery stenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vertebrobasilar insufficiency
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Loss of consciousness
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
|
|
Agranulocytosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Anaemia
|
|
|
|
|
subjects affected / exposed
|
8 / 4131 (0.19%) |
6 / 4157 (0.14%) |
3 / 4140 (0.07%) |
5 / 4140 (0.12%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 7 |
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bone marrow oedema
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coagulopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Febrile neutropenia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhagic anaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypercoagulation
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypersplenism
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Immune thrombocytopenic purpura
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Iron deficiency anaemia
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
2 / 4157 (0.05%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Leukocytosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lymphadenopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lymphadenopathy mediastinal
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Microcytic anaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neutropenia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Normochromic normocytic anaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Polycythaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Splenic vein thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spontaneous haematoma
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thrombocytosis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
|
|
Meniere's disease
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tinnitus
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tympanic membrane perforation
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vertigo
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
4 / 4157 (0.10%) |
1 / 4140 (0.02%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vertigo positional
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vestibular disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
|
|
Angle closure glaucoma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blindness unilateral
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cataract
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
5 / 4157 (0.12%) |
8 / 4140 (0.19%) |
6 / 4140 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
0 / 8 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cataract cortical
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diplopia
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Eye haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Eyelid ptosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Glaucoma
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Iridodonesis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lens dislocation
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ocular hypertension
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ocular ischaemic syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Retinal artery occlusion
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Retinal detachment
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
2 / 4140 (0.05%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Retinal disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Retinal tear
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Retinal vascular disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vitreous prolapse
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
|
|
Abdominal distension
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal hernia
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
5 / 4140 (0.12%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal incarcerated hernia
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
3 / 4157 (0.07%) |
2 / 4140 (0.05%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute abdomen
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
2 / 4157 (0.05%) |
2 / 4140 (0.05%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
Anal fissure
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anal fistula
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ascites
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic gastritis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
2 / 4157 (0.05%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colitis
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colitis ischaemic
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colitis ulcerative
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Constipation
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Crohn's disease
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
2 / 4157 (0.05%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dental caries
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
|
|
subjects affected / exposed
|
4 / 4131 (0.10%) |
3 / 4157 (0.07%) |
1 / 4140 (0.02%) |
6 / 4140 (0.14%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dieulafoy's vascular malformation
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulum
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulum intestinal haemorrhagic
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Duodenal stenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Duodenal ulcer
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Duodenal ulcer haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Duodenitis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dyspepsia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Enteritis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Enterocutaneous fistula
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Enterovesical fistula
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Erosive duodenitis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Femoral hernia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastric haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Gastric ulcer
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
2 / 4157 (0.05%) |
4 / 4140 (0.10%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastric ulcer haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastric ulcer perforation
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastritis
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
2 / 4157 (0.05%) |
5 / 4140 (0.12%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastritis erosive
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastritis haemorrhagic
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
2 / 4140 (0.05%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastroduodenal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
4 / 4131 (0.10%) |
4 / 4157 (0.10%) |
4 / 4140 (0.10%) |
4 / 4140 (0.10%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
Gastrointestinal necrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrooesophageal reflux disease
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gingival bleeding
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haematochezia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhoidal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhoids
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
2 / 4157 (0.05%) |
2 / 4140 (0.05%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hiatus hernia
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ileus
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
2 / 4157 (0.05%) |
5 / 4140 (0.12%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ileus paralytic
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Incarcerated inguinal hernia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Incarcerated umbilical hernia
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Inflammatory bowel disease
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
|
|
subjects affected / exposed
|
8 / 4131 (0.19%) |
4 / 4157 (0.10%) |
4 / 4140 (0.10%) |
8 / 4140 (0.19%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 4 |
0 / 4 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal hernia strangulated
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal infarction
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal ischaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal obstruction
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
3 / 4157 (0.07%) |
3 / 4140 (0.07%) |
4 / 4140 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal perforation
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal polyp
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intra-abdominal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Irritable bowel syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Large intestinal stenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Large intestine perforation
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Large intestine polyp
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
1 / 4157 (0.02%) |
2 / 4140 (0.05%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lower gastrointestinal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
2 / 4157 (0.05%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mallory-Weiss syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mechanical ileus
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Melaena
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
2 / 4157 (0.05%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mouth ulceration
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nausea
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Noninfective sialoadenitis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oedematous pancreatitis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oesophagitis ulcerative
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatic necrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Pancreatitis
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
4 / 4157 (0.10%) |
3 / 4140 (0.07%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Pancreatitis acute
|
|
|
|
|
subjects affected / exposed
|
4 / 4131 (0.10%) |
7 / 4157 (0.17%) |
2 / 4140 (0.05%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 7 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
Pancreatitis chronic
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peptic ulcer
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
2 / 4157 (0.05%) |
3 / 4140 (0.07%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Peptic ulcer haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Peptic ulcer perforation
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peritoneal adhesions
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peritoneal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peritoneal perforation
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Proctitis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
2 / 4157 (0.05%) |
3 / 4140 (0.07%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Small intestinal perforation
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
2 / 4140 (0.05%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subileus
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Umbilical hernia
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
3 / 4131 (0.07%) |
5 / 4157 (0.12%) |
1 / 4140 (0.02%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Varices oesophageal
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
|
|
Alcoholic liver disease
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bile duct stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bile duct stone
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholangitis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Cholecystitis
|
|
|
|
|
subjects affected / exposed
|
7 / 4131 (0.17%) |
4 / 4157 (0.10%) |
2 / 4140 (0.05%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis acute
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
2 / 4157 (0.05%) |
3 / 4140 (0.07%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis chronic
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
2 / 4140 (0.05%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
|
|
subjects affected / exposed
|
5 / 4131 (0.12%) |
3 / 4157 (0.07%) |
4 / 4140 (0.10%) |
8 / 4140 (0.19%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
0 / 4 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic hepatitis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Hepatic cirrhosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic failure
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
Hepatic function abnormal
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic steatosis
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis acute
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatorenal failure
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Hepatorenal syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperbilirubinaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Jaundice cholestatic
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Liver disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Liver injury
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Portal hypertension
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post cholecystectomy syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
|
|
Angioedema
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dermal cyst
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dermatitis allergic
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dermatitis exfoliative
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic foot
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Erythema nodosum
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Idiopathic angioedema
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neuropathic ulcer
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Photosensitivity reaction
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pruritus
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rash
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin lesion
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin maceration
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin oedema
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin sensitisation
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin ulcer
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
2 / 4157 (0.05%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urticaria
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
|
|
Acute kidney injury
|
|
|
|
|
subjects affected / exposed
|
7 / 4131 (0.17%) |
7 / 4157 (0.17%) |
8 / 4140 (0.19%) |
9 / 4140 (0.22%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
0 / 8 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 2 |
Acute prerenal failure
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Azotaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder neck sclerosis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder stenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Calculus bladder
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Calculus ureteric
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Calculus urinary
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic kidney disease
|
|
|
|
|
subjects affected / exposed
|
4 / 4131 (0.10%) |
6 / 4157 (0.14%) |
2 / 4140 (0.05%) |
4 / 4140 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Cystitis haemorrhagic
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic nephropathy
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dysuria
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haematuria
|
|
|
|
|
subjects affected / exposed
|
4 / 4131 (0.10%) |
1 / 4157 (0.02%) |
2 / 4140 (0.05%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
2 / 4157 (0.05%) |
4 / 4140 (0.10%) |
4 / 4140 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nocturia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Obstructive uropathy
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prerenal failure
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal cyst
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal failure
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
7 / 4157 (0.17%) |
2 / 4140 (0.05%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 7 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Renal mass
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tubulointerstitial nephritis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urethral disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urethral stenosis
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary bladder polyp
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary incontinence
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary retention
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
4 / 4157 (0.10%) |
1 / 4140 (0.02%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 4 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
|
|
Addison's disease
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Adrenal insufficiency
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Autoimmune thyroiditis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Basedow's disease
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Goitre
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
3 / 4140 (0.07%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperparathyroidism secondary
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperthyroidism
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypothyroidism
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Primary hyperaldosteronism
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
|
|
Arthralgia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
4 / 4140 (0.10%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arthrofibrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Back pain
|
|
|
|
|
subjects affected / exposed
|
3 / 4131 (0.07%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
4 / 4140 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bone lesion
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bursitis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cervical spinal stenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chondrocalcinosis pyrophosphate
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coccydynia
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Costochondritis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dupuytren's contracture
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
2 / 4157 (0.05%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fibromyalgia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Foot deformity
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fracture nonunion
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gouty arthritis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral disc degeneration
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
2 / 4140 (0.05%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral disc disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
2 / 4157 (0.05%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
|
|
subjects affected / exposed
|
3 / 4131 (0.07%) |
3 / 4157 (0.07%) |
5 / 4140 (0.12%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Joint effusion
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar spinal stenosis
|
|
|
|
|
subjects affected / exposed
|
3 / 4131 (0.07%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Muscle haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Muscular weakness
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal chest pain
|
|
|
|
|
subjects affected / exposed
|
4 / 4131 (0.10%) |
1 / 4157 (0.02%) |
4 / 4140 (0.10%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal pain
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myositis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neck pain
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
|
|
subjects affected / exposed
|
14 / 4131 (0.34%) |
10 / 4157 (0.24%) |
11 / 4140 (0.27%) |
8 / 4140 (0.19%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 10 |
0 / 11 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteochondrosis
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteonecrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
2 / 4140 (0.05%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pathological fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Periarthritis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Polyarthritis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Polymyalgia rheumatica
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rheumatoid arthritis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rotator cuff syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Scoliosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal column stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal pain
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spondylitis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spondylolisthesis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Synovitis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Systemic lupus erythematosus
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tendonitis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tenosynovitis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vertebral foraminal stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal osteoarthritis
|
|
|
|
|
subjects affected / exposed
|
3 / 4131 (0.07%) |
0 / 4157 (0.00%) |
4 / 4140 (0.10%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
|
|
Abdominal sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abscess intestinal
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abscess limb
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abscess neck
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute hepatitis B
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute sinusitis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
2 / 4157 (0.05%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Amoebiasis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anal abscess
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
|
|
subjects affected / exposed
|
3 / 4131 (0.07%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Appendicitis perforated
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis bacterial
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atypical mycobacterial infection
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Biliary sepsis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Biliary tract infection
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Breast abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
|
|
subjects affected / exposed
|
12 / 4131 (0.29%) |
9 / 4157 (0.22%) |
6 / 4140 (0.14%) |
6 / 4140 (0.14%) |
occurrences causally related to treatment / all
|
1 / 15 |
2 / 9 |
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
Bronchitis bacterial
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchopneumonia
|
|
|
|
|
subjects affected / exposed
|
3 / 4131 (0.07%) |
8 / 4157 (0.19%) |
7 / 4140 (0.17%) |
4 / 4140 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 8 |
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 2 |
0 / 0 |
Bronchopulmonary aspergillosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
|
|
subjects affected / exposed
|
5 / 4131 (0.12%) |
10 / 4157 (0.24%) |
0 / 4140 (0.00%) |
6 / 4140 (0.14%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 10 |
0 / 0 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholangitis infective
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis infective
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium difficile colitis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium difficile infection
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cystitis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
2 / 4140 (0.05%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device related infection
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic foot infection
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diarrhoea infectious
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
3 / 4157 (0.07%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
|
|
subjects affected / exposed
|
4 / 4131 (0.10%) |
2 / 4157 (0.05%) |
3 / 4140 (0.07%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Embolic pneumonia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Emphysematous cystitis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Endocarditis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
Endophthalmitis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Epididymitis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Escherichia sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Escherichia urinary tract infection
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gallbladder empyema
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gangrene
|
|
|
|
|
subjects affected / exposed
|
3 / 4131 (0.07%) |
3 / 4157 (0.07%) |
1 / 4140 (0.02%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Gastroenteritis
|
|
|
|
|
subjects affected / exposed
|
6 / 4131 (0.15%) |
2 / 4157 (0.05%) |
3 / 4140 (0.07%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis staphylococcal
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal fungal infection
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Graft infection
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Groin abscess
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haematoma infection
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis A
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis C
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis E
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Herpes zoster
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
2 / 4157 (0.05%) |
3 / 4140 (0.07%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Herpes zoster disseminated
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Incision site abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infected bites
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infected skin ulcer
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infection
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infective exacerbation of chronic obstructive airways disease
|
|
|
|
|
subjects affected / exposed
|
4 / 4131 (0.10%) |
6 / 4157 (0.14%) |
3 / 4140 (0.07%) |
6 / 4140 (0.14%) |
occurrences causally related to treatment / all
|
0 / 4 |
2 / 7 |
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Influenza
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
4 / 4140 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Intervertebral discitis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Kidney infection
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Laryngitis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lobar pneumonia
|
|
|
|
|
subjects affected / exposed
|
8 / 4131 (0.19%) |
8 / 4157 (0.19%) |
5 / 4140 (0.12%) |
9 / 4140 (0.22%) |
occurrences causally related to treatment / all
|
1 / 9 |
0 / 8 |
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Lower respiratory tract infection
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
4 / 4157 (0.10%) |
0 / 4140 (0.00%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 4 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
2 / 4157 (0.05%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung infection
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lymph gland infection
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lymph node abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Meningitis aseptic
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Meningoencephalitis herpetic
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Necrotising fasciitis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neuroborreliosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Orchitis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
2 / 4140 (0.05%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oropharyngeal candidiasis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
4 / 4157 (0.10%) |
1 / 4140 (0.02%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Otitis externa
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Otitis externa bacterial
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Parainfluenzae virus infection
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Periorbital cellulitis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peritonitis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
2 / 4157 (0.05%) |
4 / 4140 (0.10%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Pharyngotonsillitis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumococcal infection
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
|
|
subjects affected / exposed
|
113 / 4131 (2.74%) |
121 / 4157 (2.91%) |
90 / 4140 (2.17%) |
123 / 4140 (2.97%) |
occurrences causally related to treatment / all
|
3 / 128 |
13 / 145 |
3 / 99 |
11 / 140 |
deaths causally related to treatment / all
|
0 / 8 |
2 / 10 |
0 / 3 |
0 / 14 |
Pneumonia bacterial
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia haemophilus
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia moraxella
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Pneumonia staphylococcal
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia streptococcal
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative wound infection
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pseudomembranous colitis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary tuberculosis
|
|
|
|
|
subjects affected / exposed
|
3 / 4131 (0.07%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Purulent discharge
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pyelocystitis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pyelonephritis acute
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
2 / 4157 (0.05%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
2 / 4157 (0.05%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory tract infection bacterial
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Salmonella sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Scrotal abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sepsis
|
|
|
|
|
subjects affected / exposed
|
10 / 4131 (0.24%) |
4 / 4157 (0.10%) |
4 / 4140 (0.10%) |
8 / 4140 (0.19%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 4 |
0 / 4 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 2 |
0 / 1 |
Septic shock
|
|
|
|
|
subjects affected / exposed
|
5 / 4131 (0.12%) |
2 / 4157 (0.05%) |
2 / 4140 (0.05%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 1 |
0 / 1 |
Sialoadenitis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sinusitis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin infection
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal infection
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
2 / 4140 (0.05%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thrombophlebitis septic
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tooth abscess
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Toxic shock syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
2 / 4140 (0.05%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
Tuberculosis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
3 / 4157 (0.07%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Tuberculous pleurisy
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Typhoid fever
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Upper respiratory tract infection
|
|
|
|
|
subjects affected / exposed
|
3 / 4131 (0.07%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
|
|
subjects affected / exposed
|
5 / 4131 (0.12%) |
7 / 4157 (0.17%) |
6 / 4140 (0.14%) |
9 / 4140 (0.22%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
0 / 6 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Urinary tract infection bacterial
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
2 / 4140 (0.05%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Vestibular neuronitis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Viral myocarditis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wound infection
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
1 / 4140 (0.02%) |
2 / 4140 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
|
|
Acidosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cachexia
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Decreased appetite
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dehydration
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
2 / 4157 (0.05%) |
3 / 4140 (0.07%) |
3 / 4140 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetes mellitus
|
|
|
|
|
subjects affected / exposed
|
5 / 4131 (0.12%) |
1 / 4157 (0.02%) |
6 / 4140 (0.14%) |
4 / 4140 (0.10%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetes mellitus inadequate control
|
|
|
|
|
subjects affected / exposed
|
4 / 4131 (0.10%) |
6 / 4157 (0.14%) |
2 / 4140 (0.05%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic ketoacidosis
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Electrolyte imbalance
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gout
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypercalcaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
2 / 4140 (0.05%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypercholesterolaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
2 / 4157 (0.05%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
|
|
subjects affected / exposed
|
3 / 4131 (0.07%) |
0 / 4157 (0.00%) |
2 / 4140 (0.05%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypertriglyceridaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
|
|
subjects affected / exposed
|
4 / 4131 (0.10%) |
3 / 4157 (0.07%) |
0 / 4140 (0.00%) |
4 / 4140 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
0 / 4157 (0.00%) |
1 / 4140 (0.02%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
|
|
subjects affected / exposed
|
2 / 4131 (0.05%) |
1 / 4157 (0.02%) |
4 / 4140 (0.10%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypovolaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malnutrition
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metabolic acidosis
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Obesity
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
0 / 4157 (0.00%) |
0 / 4140 (0.00%) |
1 / 4140 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Type 2 diabetes mellitus
|
|
|
|
|
subjects affected / exposed
|
1 / 4131 (0.02%) |
2 / 4157 (0.05%) |
2 / 4140 (0.05%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vitamin D deficiency
|
|
|
|
|
subjects affected / exposed
|
0 / 4131 (0.00%) |
1 / 4157 (0.02%) |
0 / 4140 (0.00%) |
0 / 4140 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |