Serious adverse events
|
Evacetrapib |
Placebo |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
2306 / 6036 (38.20%) |
2341 / 6052 (38.68%) |
number of deaths (all causes)
|
240 |
287 |
number of deaths resulting from adverse events
|
8 |
5 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
acute myeloid leukaemia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
adenocarcinoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
adenocarcinoma gastric
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
adenocarcinoma of colon
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
5 / 6052 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
adenocarcinoma pancreas
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
adenosquamous cell lung cancer
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
anal squamous cell carcinoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
anaplastic astrocytoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
b-cell lymphoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
b-cell lymphoma stage iv
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
basal cell carcinoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
17 / 6036 (0.28%) |
13 / 6052 (0.21%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
basosquamous carcinoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
benign gastric neoplasm
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
benign neoplasm of spinal cord
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
benign neoplasm of adrenal gland
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
benign neoplasm of thyroid gland
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
benign renal neoplasm
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bladder cancer
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
8 / 6036 (0.13%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bladder cancer recurrent
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bladder neoplasm
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bladder transitional cell carcinoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
5 / 6052 (0.08%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
borderline mucinous tumour of ovary
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bowen's disease
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
breast cancer
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
6 / 6036 (0.10%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
breast cancer metastatic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bronchial carcinoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 1 |
bronchial neoplasm
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
burkitt's lymphoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
buschke-lowenstein's tumour
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
carcinoid tumour
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
carcinoid tumour of the gastrointestinal tract
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cervix carcinoma stage 0
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [1]
|
1 / 1388 (0.07%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cholangiocarcinoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
chronic lymphocytic leukaemia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
chronic lymphocytic leukaemia stage 0
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
chronic myeloid leukaemia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
colon adenoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
5 / 6036 (0.08%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
colon cancer
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
7 / 6052 (0.12%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
colon cancer metastatic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
colon cancer stage 0
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
colon cancer stage iii
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
colon cancer stage iv
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
colorectal cancer
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
colorectal cancer metastatic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
colorectal cancer stage iv
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
desmoplastic melanoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
diffuse large b-cell lymphoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
diffuse large b-cell lymphoma recurrent
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
diffuse large b-cell lymphoma stage ii
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
diffuse large b-cell lymphoma stage iii
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
endometrial adenocarcinoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ewing's sarcoma metastatic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
fallopian tube cancer
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [2]
|
0 / 6036 (0.00%) |
1 / 1394 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
fibrous histiocytoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gallbladder adenocarcinoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastric adenoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastric cancer
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
6 / 6052 (0.10%) |
occurrences causally related to treatment / all
|
2 / 5 |
1 / 7 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 2 |
gastrointestinal cancer metastatic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastrointestinal stromal tumour
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastrointestinal tract adenoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastrooesophageal cancer
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
gingival cancer
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
glioblastoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
haemangioma of liver
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hepatic cancer
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
hepatic cancer metastatic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
hepatocellular carcinoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
hodgkin's disease
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hodgkin's disease stage iv
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
intestinal adenocarcinoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
invasive breast carcinoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
invasive lobular breast carcinoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
invasive ductal breast carcinoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
kaposi's sarcoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
keratinising squamous cell carcinoma of nasopharynx
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
keratoacanthoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
large intestine benign neoplasm
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
laryngeal cancer
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
laryngeal neoplasm
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
laryngeal squamous cell carcinoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lip squamous cell carcinoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lipoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lung adenocarcinoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
7 / 6036 (0.12%) |
7 / 6052 (0.12%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 5 |
lung adenocarcinoma stage i
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lung adenocarcinoma stage ii
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lung adenocarcinoma stage iii
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lung cancer metastatic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
lung carcinoma cell type unspecified recurrent
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lung carcinoma cell type unspecified stage ii
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lung carcinoma cell type unspecified stage iii
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lung carcinoma cell type unspecified stage iv
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
lung neoplasm
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lung neoplasm malignant
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
14 / 6036 (0.23%) |
13 / 6052 (0.21%) |
occurrences causally related to treatment / all
|
0 / 15 |
1 / 13 |
deaths causally related to treatment / all
|
0 / 7 |
1 / 8 |
lung squamous cell carcinoma metastatic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lung squamous cell carcinoma stage i
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lung squamous cell carcinoma stage iii
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lymphocytic lymphoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lymphoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
malignant fibrous histiocytoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
malignant melanoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
5 / 6036 (0.08%) |
6 / 6052 (0.10%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
malignant melanoma in situ
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
malignant neoplasm of unknown primary site
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
malignant neoplasm progression
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
malignant pleural effusion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
mediastinum neoplasm
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
meningioma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
meningioma malignant
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
metastases to bone
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
metastases to central nervous system
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
metastases to liver
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
metastases to lymph nodes
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
metastases to lung
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
metastases to salivary gland
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
metastatic malignant melanoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
metastatic squamous cell carcinoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
myelodysplastic syndrome
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
myxofibrosarcoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
nasal sinus cancer
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
nasopharyngeal cancer
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
neoplasm progression
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
neoplasm prostate
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [3]
|
0 / 6036 (0.00%) |
1 / 4658 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
neoplasm skin
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
neuroendocrine carcinoma metastatic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
neuroendocrine tumour
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
non-hodgkin's lymphoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
non-small cell lung cancer
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
non-small cell lung cancer metastatic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
non-small cell lung cancer stage iii
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
non-small cell lung cancer stage iiia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
non-small cell lung cancer stage iv
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
oesophageal adenocarcinoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
oesophageal adenocarcinoma metastatic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 1 |
oesophageal adenocarcinoma stage 0
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
oesophageal carcinoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
oral cavity cancer metastatic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
oropharyngeal cancer
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
oropharyngeal squamous cell carcinoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pancreatic carcinoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
7 / 6052 (0.12%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 8 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
pancreatic carcinoma metastatic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
pancreatic neoplasm
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pancreatic neuroendocrine tumour
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
papillary cystadenoma lymphomatosum
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
papillary thyroid cancer
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
parathyroid tumour benign
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
phaeochromocytoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pituitary tumour
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
plasma cell myeloma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
polycythaemia vera
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
prostate cancer
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [4]
|
26 / 4648 (0.56%) |
28 / 4658 (0.60%) |
occurrences causally related to treatment / all
|
0 / 26 |
0 / 28 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
prostate cancer metastatic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [5]
|
0 / 6036 (0.00%) |
1 / 4658 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
prostate cancer recurrent
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [6]
|
3 / 4648 (0.06%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
prostate cancer stage ii
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [7]
|
2 / 4648 (0.04%) |
1 / 4658 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
prostate cancer stage iv
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [8]
|
0 / 6036 (0.00%) |
1 / 4658 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
prostatic adenoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [9]
|
1 / 4648 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
rectal adenocarcinoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
rectal cancer
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
rectal cancer metastatic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
rectal cancer stage 0
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
renal cancer
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
renal cancer recurrent
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
renal cell carcinoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
5 / 6036 (0.08%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
sinonasal papilloma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
skin cancer
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
small cell lung cancer
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
small cell lung cancer metastatic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
spinal cord neoplasm
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
squamous cell carcinoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
6 / 6036 (0.10%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
squamous cell carcinoma of lung
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
squamous cell carcinoma of skin
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
5 / 6036 (0.08%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
squamous cell carcinoma of the tongue
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
squamous cell carcinoma of the oral cavity
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
squamous cell carcinoma of the vulva
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
t-cell lymphoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
testicular neoplasm
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [10]
|
1 / 4648 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
testicular seminoma (pure)
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [11]
|
0 / 6036 (0.00%) |
1 / 4658 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
throat cancer
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
thymoma malignant
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
thyroid cancer
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
thyroid neoplasm
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
tongue carcinoma stage iv
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
tongue neoplasm malignant stage unspecified
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
tonsil cancer
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
tonsil cancer metastatic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
transitional cell carcinoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
transitional cell carcinoma recurrent
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ureteric cancer
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
uterine cancer
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [12]
|
0 / 6036 (0.00%) |
1 / 1394 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
uterine leiomyoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [13]
|
1 / 1388 (0.07%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
uterine neoplasm
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [14]
|
0 / 6036 (0.00%) |
1 / 1394 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
accelerated hypertension
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
aneurysm
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
aortic aneurysm
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
18 / 6036 (0.30%) |
14 / 6052 (0.23%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
aortic aneurysm rupture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
aortic dissection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
aortic occlusion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
aortic elongation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
aortic rupture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
aortic stenosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
18 / 6036 (0.30%) |
17 / 6052 (0.28%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
aortitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
arterial haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
arterial disorder
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
arterial insufficiency
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
arterial occlusive disease
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
arterial perforation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
arterial stenosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
arterial thrombosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
arteriosclerosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
artery dissection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
axillary vein thrombosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
blood pressure inadequately controlled
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
brachiocephalic artery stenosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
circulatory collapse
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
deep vein thrombosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
11 / 6036 (0.18%) |
16 / 6052 (0.26%) |
occurrences causally related to treatment / all
|
0 / 12 |
1 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
dry gangrene
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
embolism arterial
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
extremity necrosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
femoral artery aneurysm
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
femoral artery occlusion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
7 / 6036 (0.12%) |
7 / 6052 (0.12%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
femoral artery perforation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
haematoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
7 / 6036 (0.12%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hypertension
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
21 / 6036 (0.35%) |
18 / 6052 (0.30%) |
occurrences causally related to treatment / all
|
1 / 23 |
2 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hypertensive crisis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
9 / 6036 (0.15%) |
14 / 6052 (0.23%) |
occurrences causally related to treatment / all
|
1 / 9 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hypertensive emergency
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hypotension
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
11 / 6036 (0.18%) |
17 / 6052 (0.28%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hypovolaemic shock
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
iliac artery occlusion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
iliac artery rupture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
intermittent claudication
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
7 / 6036 (0.12%) |
16 / 6052 (0.26%) |
occurrences causally related to treatment / all
|
0 / 7 |
1 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
jugular vein thrombosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lymphatic fistula
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lymphorrhoea
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
malignant hypertension
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
orthostatic hypotension
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
11 / 6036 (0.18%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
1 / 11 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
peripheral arterial occlusive disease
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
52 / 6036 (0.86%) |
50 / 6052 (0.83%) |
occurrences causally related to treatment / all
|
0 / 66 |
1 / 66 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
peripheral artery aneurysm
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
peripheral artery stenosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
19 / 6036 (0.31%) |
10 / 6052 (0.17%) |
occurrences causally related to treatment / all
|
0 / 21 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
peripheral artery thrombosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
6 / 6052 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
peripheral embolism
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
peripheral ischaemia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
12 / 6036 (0.20%) |
20 / 6052 (0.33%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 25 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
peripheral vascular disorder
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
21 / 6036 (0.35%) |
10 / 6052 (0.17%) |
occurrences causally related to treatment / all
|
0 / 25 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
shock
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
shock haemorrhagic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
subclavian artery occlusion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
subclavian artery stenosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
subclavian artery thrombosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
temporal arteritis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
thrombophlebitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
thrombophlebitis superficial
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
thrombosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
varicose vein
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
vascular occlusion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
vasculitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
vena cava thrombosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
venous thrombosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
venous thrombosis limb
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
abdominal hernia repair
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
adrenalectomy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
amputation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
analgesic therapy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
aneurysm repair
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
angioplasty
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
12 / 6036 (0.20%) |
8 / 6052 (0.13%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ankle arthroplasty
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
aortic aneurysm repair
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
aortic bypass
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
aortic valve repair
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
aortic valve replacement
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
arterial stent insertion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
atherectomy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
atrial septal defect repair
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
autonomic nerve operation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bladder neck suspension
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [15]
|
1 / 1388 (0.07%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bone operation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bronchial lesion excision
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cancer surgery
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cardiac ablation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
6 / 6052 (0.10%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cardiac pacemaker battery replacement
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cardiac pacemaker insertion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
6 / 6036 (0.10%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cardiac pacemaker replacement
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cardiac rehabilitation therapy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cardiac resynchronisation therapy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cardioversion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
carotid angioplasty
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
carotid endarterectomy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
6 / 6052 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
carotid revascularisation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
carpal tunnel decompression
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
catheter placement
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cataract operation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cholecystectomy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
5 / 6052 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
colectomy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
colostomy closure
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
coronary angioplasty
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
13 / 6036 (0.22%) |
21 / 6052 (0.35%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 23 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
coronary arterial stent insertion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
11 / 6036 (0.18%) |
12 / 6052 (0.20%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
coronary artery bypass
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
54 / 6036 (0.89%) |
59 / 6052 (0.97%) |
occurrences causally related to treatment / all
|
0 / 54 |
0 / 59 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
coronary revascularisation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
82 / 6036 (1.36%) |
79 / 6052 (1.31%) |
occurrences causally related to treatment / all
|
0 / 92 |
0 / 89 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cox-maze procedure
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
debridement
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
diaphragmatic operation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
elective surgery
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
endarterectomy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
endovenous ablation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
exploratory operation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
explorative laparotomy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
eye operation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
foot amputation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastrectomy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastric bypass
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastrointestinal endoscopic therapy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
haematoma evacuation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
heart valve replacement
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hernia repair
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hip arthroplasty
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
11 / 6036 (0.18%) |
7 / 6052 (0.12%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
high frequency ablation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hip surgery
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hospitalisation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hysterectomy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [16]
|
1 / 1388 (0.07%) |
1 / 1394 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
implantable defibrillator insertion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
11 / 6036 (0.18%) |
13 / 6052 (0.21%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
implantable defibrillator replacement
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
incisional drainage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
incisional hernia repair
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
inguinal hernia repair
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
5 / 6052 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
intervertebral disc operation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
intraocular lens implant
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
joint arthroplasty
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
knee arthroplasty
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
12 / 6036 (0.20%) |
12 / 6052 (0.20%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
knee operation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
leg amputation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
5 / 6036 (0.08%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lens extraction
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lipoma excision
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
mastectomy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
medical device change
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
medical device removal
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
mitral valve replacement
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
nephrectomy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
open reduction of fracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
osteosynthesis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
osteotomy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pancreatectomy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pancreaticoduodenectomy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
penile repair
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [17]
|
0 / 6036 (0.00%) |
1 / 4658 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
percutaneous coronary intervention
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
192 / 6036 (3.18%) |
182 / 6052 (3.01%) |
occurrences causally related to treatment / all
|
1 / 217 |
1 / 214 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
peripheral artery angioplasty
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
peripheral artery bypass
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
5 / 6036 (0.08%) |
6 / 6052 (0.10%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
peripheral artery stent insertion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
peripheral endarterectomy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
6 / 6052 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
peripheral nerve transposition
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
peripheral revascularisation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
prostate ablation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
prostatectomy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [18]
|
0 / 6036 (0.00%) |
2 / 4658 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
radioactive iodine therapy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
rectal prolapse repair
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
renal artery angioplasty
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
renal sympathetic nerve ablation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
resection of rectum
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
resuscitation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
retinopexy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
rotator cuff repair
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
shoulder arthroplasty
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
shoulder operation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
skin neoplasm excision
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
spinal decompression
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
spinal fusion surgery
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
5 / 6036 (0.08%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
spinal laminectomy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
spinal operation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
stent placement
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
sympathectomy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
tenotomy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
therapeutic embolisation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
therapy cessation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
thrombectomy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
thrombosis prophylaxis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
thyroidectomy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
toe amputation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
tongue operation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
total adrenalectomy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
transmyocardial revascularisation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
transurethral bladder resection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
transurethral prostatectomy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [19]
|
2 / 4648 (0.04%) |
1 / 4658 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
tricuspid valve repair
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
tumour excision
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ureteral stent insertion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ureteral stent removal
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
vaginal prolapse repair
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [20]
|
1 / 1388 (0.07%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
valvuloplasty cardiac
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
vascular graft
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
venous stent insertion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ventricular assist device insertion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
vitrectomy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
wound drainage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pregnancy, puerperium and perinatal conditions
|
|
|
abortion spontaneous
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [21]
|
0 / 6036 (0.00%) |
1 / 1394 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pregnancy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [22]
|
0 / 6036 (0.00%) |
1 / 1394 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
adverse drug reaction
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
asthenia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
5 / 6036 (0.08%) |
9 / 6052 (0.15%) |
occurrences causally related to treatment / all
|
0 / 5 |
2 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cardiac death
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
5 / 6052 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 5 |
chest discomfort
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
7 / 6036 (0.12%) |
12 / 6052 (0.20%) |
occurrences causally related to treatment / all
|
0 / 7 |
2 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
chest pain
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
37 / 6036 (0.61%) |
34 / 6052 (0.56%) |
occurrences causally related to treatment / all
|
3 / 38 |
0 / 42 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
death
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
20 / 6036 (0.33%) |
14 / 6052 (0.23%) |
occurrences causally related to treatment / all
|
2 / 20 |
0 / 14 |
deaths causally related to treatment / all
|
2 / 20 |
0 / 14 |
device breakage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
device dislocation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
device end of service
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
device inappropriate shock delivery
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
device failure
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
device malfunction
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
6 / 6052 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
device material issue
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
device occlusion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
drowning
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
drug withdrawal syndrome
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
exercise tolerance decreased
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gait disturbance
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
general physical health deterioration
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
generalised oedema
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
granuloma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hyperthermia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hypertrophy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hypothermia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
impaired healing
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
implant site haematoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
incarcerated hernia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ischaemic ulcer
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lead dislodgement
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
multi-organ failure
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
6 / 6052 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 4 |
necrosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
necrobiosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
non-cardiac chest pain
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
107 / 6036 (1.77%) |
108 / 6052 (1.78%) |
occurrences causally related to treatment / all
|
1 / 123 |
1 / 118 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
oedema
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
oedema peripheral
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pain
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pelvic mass
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
peripheral swelling
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
precancerous mucosal lesion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pyrexia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
stent-graft endoleak
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
sudden cardiac death
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
16 / 6036 (0.27%) |
15 / 6052 (0.25%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 16 |
0 / 15 |
sudden death
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
systemic inflammatory response syndrome
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
thrombosis in device
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ulcer haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
vascular stent occlusion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
vascular stent restenosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
6 / 6036 (0.10%) |
5 / 6052 (0.08%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
vascular stent stenosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
vascular stent thrombosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
vessel puncture site haematoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
anaphylactic reaction
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
anaphylactic shock
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
drug hypersensitivity
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hypersensitivity
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
amastia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
benign prostatic hyperplasia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [23]
|
10 / 4648 (0.22%) |
12 / 4658 (0.26%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
cervical polyp
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [24]
|
0 / 6036 (0.00%) |
1 / 1394 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cystocele
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [25]
|
1 / 1388 (0.07%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
dysmenorrhoea
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [26]
|
0 / 6036 (0.00%) |
1 / 1394 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
menometrorrhagia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [27]
|
0 / 6036 (0.00%) |
1 / 1394 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ovarian cyst
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [28]
|
2 / 1388 (0.14%) |
1 / 1394 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
penile necrosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [29]
|
0 / 6036 (0.00%) |
1 / 4658 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
peyronie's disease
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [30]
|
1 / 4648 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
prostatitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [31]
|
4 / 4648 (0.09%) |
2 / 4658 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
rectocele
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [32]
|
0 / 6036 (0.00%) |
1 / 1394 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
testicular disorder
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [33]
|
1 / 4648 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
uterine polyp
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [34]
|
1 / 1388 (0.07%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
uterine prolapse
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [35]
|
2 / 1388 (0.14%) |
2 / 1394 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
acute pulmonary oedema
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
8 / 6036 (0.13%) |
5 / 6052 (0.08%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
acute respiratory distress syndrome
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
acute respiratory failure
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
14 / 6036 (0.23%) |
20 / 6052 (0.33%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
alveolitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
aspiration
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
asphyxia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
asthma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
8 / 6036 (0.13%) |
5 / 6052 (0.08%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
atelectasis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bronchiectasis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bronchitis chronic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bronchospasm
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
chronic obstructive pulmonary disease
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
43 / 6036 (0.71%) |
47 / 6052 (0.78%) |
occurrences causally related to treatment / all
|
0 / 55 |
0 / 55 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
chylothorax
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cough
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
dyspnoea
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
26 / 6036 (0.43%) |
23 / 6052 (0.38%) |
occurrences causally related to treatment / all
|
0 / 29 |
0 / 23 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
dyspnoea exertional
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
6 / 6036 (0.10%) |
10 / 6052 (0.17%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
emphysema
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
epistaxis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
6 / 6036 (0.10%) |
6 / 6052 (0.10%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
haemoptysis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
7 / 6052 (0.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
haemothorax
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hiccups
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hydrothorax
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hypercapnia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hypoxia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
7 / 6036 (0.12%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
idiopathic pulmonary fibrosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
interstitial lung disease
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lung consolidation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lung infiltration
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
mediastinal haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
nasal septum deviation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
organising pneumonia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
1 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pickwickian syndrome
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pleural effusion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
8 / 6036 (0.13%) |
12 / 6052 (0.20%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
pleurisy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pleuritic pain
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pneumomediastinum
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pneumonia aspiration
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
7 / 6036 (0.12%) |
8 / 6052 (0.13%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
pneumonitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pneumothorax
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pneumothorax spontaneous
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pulmonary alveolar haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pulmonary arterial hypertension
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pulmonary congestion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pulmonary embolism
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
21 / 6036 (0.35%) |
20 / 6052 (0.33%) |
occurrences causally related to treatment / all
|
1 / 22 |
1 / 20 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
pulmonary fibrosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
pulmonary hypertension
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pulmonary infarction
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pulmonary mass
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
5 / 6052 (0.08%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
pulmonary oedema
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
8 / 6036 (0.13%) |
8 / 6052 (0.13%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
respiratory arrest
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
respiratory distress
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
respiratory failure
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
17 / 6036 (0.28%) |
16 / 6052 (0.26%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 5 |
sleep apnoea syndrome
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
tracheomalacia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
abnormal behaviour
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
acute psychosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
acute stress disorder
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
adjustment disorder
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
adjustment disorder with anxiety
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
adjustment disorder with depressed mood
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
adjustment disorder with mixed disturbance of emotion and conduct
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
aggression
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
alcohol abuse
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
alcohol withdrawal syndrome
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
alcoholism
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
anxiety
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
anxiety disorder
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
completed suicide
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
confusional state
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
5 / 6052 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
delirium
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
delirium tremens
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
depression
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
depression suicidal
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
generalised anxiety disorder
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hallucination
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hypomania
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
major depression
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
mental disorder
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
mental status changes
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
13 / 6052 (0.21%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
panic attack
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
post-traumatic stress disorder
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
psychogenic seizure
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
psychotic disorder
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
suicidal ideation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
suicide attempt
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
autoimmune hepatitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bile duct obstruction
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
bile duct stenosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bile duct stone
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
5 / 6036 (0.08%) |
10 / 6052 (0.17%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
biliary colic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
biliary tract disorder
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cholangitis acute
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cholangitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cholecystitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
19 / 6036 (0.31%) |
16 / 6052 (0.26%) |
occurrences causally related to treatment / all
|
0 / 20 |
1 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cholecystitis acute
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
12 / 6036 (0.20%) |
15 / 6052 (0.25%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cholecystitis chronic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cholelithiasis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
23 / 6036 (0.38%) |
22 / 6052 (0.36%) |
occurrences causally related to treatment / all
|
0 / 23 |
1 / 23 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cholestasis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gallbladder disorder
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hepatic cirrhosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
hepatic lesion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hepatic steatosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hepatitis alcoholic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hepatomegaly
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hydrocholecystis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ischaemic hepatitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
jaundice
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
jaundice cholestatic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
jaundice extrahepatic obstructive
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
liver disorder
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
liver injury
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
portal vein thrombosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigations
|
|
|
alanine aminotransferase increased
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
angiogram
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
7 / 6036 (0.12%) |
7 / 6052 (0.12%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
anticoagulation drug level above therapeutic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
arteriogram
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
arteriogram coronary
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
16 / 6036 (0.27%) |
17 / 6052 (0.28%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
arteriogram renal
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
aspartate aminotransferase increased
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
biopsy brain
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
blood creatine phosphokinase increased
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
blood creatinine increased
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
blood glucose decreased
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
blood glucose increased
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
blood osmolarity decreased
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
blood pressure increased
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cardiac function test
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cardiac stress test abnormal
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cardiovascular evaluation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cardiovascular examination
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
carotid bruit
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
catheterisation cardiac
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
10 / 6036 (0.17%) |
14 / 6052 (0.23%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
clostridium test positive
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
colonoscopy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
computerised tomogram
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
computerised tomogram thorax
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
diagnostic procedure
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ejection fraction decreased
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
5 / 6036 (0.08%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
electrocardiogram abnormal
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
electrocardiogram qt prolonged
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
endoscopy gastrointestinal
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gamma-glutamyltransferase increased
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
haemoglobin decreased
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
heart rate irregular
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hepatic enzyme increased
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
international normalised ratio decreased
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
international normalised ratio increased
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
investigation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
liver function test abnormal
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
myocardial necrosis marker increased
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
oesophagogastroduodenoscopy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
peripheral arteriogram
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
prostatic specific antigen increased
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [36]
|
2 / 4648 (0.04%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
transaminases increased
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
troponin increased
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ureteroscopy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
vitamin b12 decreased
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
weight decreased
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
abdominal wound dehiscence
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
accident
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
accidental exposure to product
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
acetabulum fracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
accidental overdose
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
alcohol poisoning
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
anaemia postoperative
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
anal injury
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
anastomotic stenosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
anastomotic ulcer haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ankle fracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
9 / 6036 (0.15%) |
5 / 6052 (0.08%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
back injury
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
brain contusion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cartilage injury
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cervical vertebral fracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
chemical burn of skin
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
chemical injury
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
chest injury
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
clavicle fracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
colon injury
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
compression fracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
concussion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
contrast media reaction
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
contusion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
coronary artery restenosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
craniocerebral injury
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
crush injury
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cystitis radiation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
extradural haematoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
eye injury
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
facial bones fracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
fall
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
39 / 6036 (0.65%) |
50 / 6052 (0.83%) |
occurrences causally related to treatment / all
|
0 / 40 |
0 / 53 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
femur fracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
6 / 6036 (0.10%) |
6 / 6052 (0.10%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
femoral neck fracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
6 / 6052 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
fibula fracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
foot fracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
foreign body
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
fracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
fractured sacrum
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastrointestinal anastomotic complication
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastrointestinal injury
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastrointestinal stoma complication
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
graft thrombosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gun shot wound
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
hand fracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
head injury
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
6 / 6036 (0.10%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
heat illness
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hip fracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
6 / 6036 (0.10%) |
7 / 6052 (0.12%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
humerus fracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
incisional hernia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
injury
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
intentional overdose
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
jaw fracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
joint injury
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
joint dislocation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
5 / 6036 (0.08%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
laceration
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ligament injury
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ligament sprain
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
limb traumatic amputation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lower limb fracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lumbar vertebral fracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
meniscus injury
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
multiple fractures
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
multiple injuries
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
muscle contusion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
muscle rupture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
muscle injury
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
nerve root injury lumbar
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
overdose
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
patella fracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pelvic fracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
peripheral arterial reocclusion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
peripheral artery restenosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
periprosthetic fracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
poisoning
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
post concussion syndrome
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
post laminectomy syndrome
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
post procedural bile leak
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
post procedural complication
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
post procedural haematoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
post procedural haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
post procedural myocardial infarction
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
5 / 6036 (0.08%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
post procedural stroke
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
postoperative fever
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
postoperative ileus
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
postoperative respiratory failure
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
postoperative thoracic procedure complication
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
postoperative wound complication
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
procedural haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
procedural hypotension
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pubis fracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pulmonary contusion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
radius fracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
rib fracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
5 / 6036 (0.08%) |
8 / 6052 (0.13%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
road traffic accident
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
15 / 6036 (0.25%) |
15 / 6052 (0.25%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 4 |
seroma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
skull fracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
soft tissue injury
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
spinal compression fracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
5 / 6052 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
spinal cord injury
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
spinal cord injury cervical
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
spinal fracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
splenic rupture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
sternal fracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
stoma site haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
subdural haematoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
7 / 6036 (0.12%) |
7 / 6052 (0.12%) |
occurrences causally related to treatment / all
|
0 / 7 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
subdural haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
tendon injury
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
tendon rupture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
8 / 6036 (0.13%) |
7 / 6052 (0.12%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
thermal burn
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
thoracic vertebral fracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
tibia fracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
5 / 6036 (0.08%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
tooth fracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
toxicity to various agents
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
traumatic amputation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
traumatic fracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
traumatic haematoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
traumatic intracranial haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
traumatic liver injury
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ulna fracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
upper limb fracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
vascular graft occlusion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
7 / 6036 (0.12%) |
7 / 6052 (0.12%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
vascular graft thrombosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
vascular pseudoaneurysm
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
vascular pseudoaneurysm ruptured
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
wound
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
wound complication
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
wound dehiscence
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
wound haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
wrist fracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
arteriovenous malformation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
atrial septal defect
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
dermoid cyst
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hydrocele
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [37]
|
0 / 6036 (0.00%) |
2 / 4658 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hypertrophic cardiomyopathy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
leukodystrophy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
phimosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [38]
|
0 / 6036 (0.00%) |
1 / 4658 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
acute coronary syndrome
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
9 / 6036 (0.15%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 9 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
acute myocardial infarction
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
146 / 6036 (2.42%) |
137 / 6052 (2.26%) |
occurrences causally related to treatment / all
|
5 / 168 |
4 / 149 |
deaths causally related to treatment / all
|
0 / 16 |
0 / 4 |
adams-stokes syndrome
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
angina pectoris
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
102 / 6036 (1.69%) |
98 / 6052 (1.62%) |
occurrences causally related to treatment / all
|
3 / 113 |
3 / 103 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
angina unstable
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
298 / 6036 (4.94%) |
289 / 6052 (4.78%) |
occurrences causally related to treatment / all
|
7 / 389 |
6 / 363 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
aortic valve disease
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
aortic valve incompetence
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
aortic valve sclerosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
aortic valve stenosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
7 / 6036 (0.12%) |
6 / 6052 (0.10%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
arrhythmia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
5 / 6036 (0.08%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
arteriosclerosis coronary artery
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
arteriospasm coronary
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
atrial flutter
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
25 / 6036 (0.41%) |
16 / 6052 (0.26%) |
occurrences causally related to treatment / all
|
0 / 27 |
1 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
atrial fibrillation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
86 / 6036 (1.42%) |
78 / 6052 (1.29%) |
occurrences causally related to treatment / all
|
1 / 109 |
2 / 94 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
atrial tachycardia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
atrial thrombosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
atrioventricular block complete
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
8 / 6036 (0.13%) |
6 / 6052 (0.10%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
atrioventricular block
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
5 / 6036 (0.08%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
atrioventricular block second degree
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
6 / 6036 (0.10%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bradyarrhythmia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
5 / 6052 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bradycardia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
8 / 6036 (0.13%) |
11 / 6052 (0.18%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cardiac arrest
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
17 / 6036 (0.28%) |
30 / 6052 (0.50%) |
occurrences causally related to treatment / all
|
1 / 18 |
0 / 32 |
deaths causally related to treatment / all
|
1 / 12 |
0 / 21 |
cardiac discomfort
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cardiac failure
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
67 / 6036 (1.11%) |
63 / 6052 (1.04%) |
occurrences causally related to treatment / all
|
1 / 79 |
1 / 78 |
deaths causally related to treatment / all
|
0 / 9 |
0 / 8 |
cardiac failure acute
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
11 / 6036 (0.18%) |
9 / 6052 (0.15%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
cardiac failure chronic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
7 / 6036 (0.12%) |
10 / 6052 (0.17%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 4 |
cardiac failure congestive
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
95 / 6036 (1.57%) |
103 / 6052 (1.70%) |
occurrences causally related to treatment / all
|
1 / 134 |
0 / 138 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 12 |
cardiac tamponade
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cardio-respiratory arrest
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
5 / 6036 (0.08%) |
6 / 6052 (0.10%) |
occurrences causally related to treatment / all
|
0 / 5 |
2 / 7 |
deaths causally related to treatment / all
|
0 / 3 |
1 / 5 |
cardiogenic shock
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
8 / 6036 (0.13%) |
7 / 6052 (0.12%) |
occurrences causally related to treatment / all
|
1 / 8 |
0 / 7 |
deaths causally related to treatment / all
|
1 / 4 |
0 / 4 |
cardiopulmonary failure
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
cardiomyopathy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
5 / 6052 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
cardiorenal syndrome
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
cardiovascular insufficiency
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
chronotropic incompetence
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
conduction disorder
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
congestive cardiomyopathy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
coronary artery disease
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
37 / 6036 (0.61%) |
44 / 6052 (0.73%) |
occurrences causally related to treatment / all
|
1 / 40 |
2 / 45 |
deaths causally related to treatment / all
|
0 / 3 |
1 / 4 |
coronary artery dissection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
coronary artery occlusion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
6 / 6052 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
coronary artery stenosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
7 / 6036 (0.12%) |
6 / 6052 (0.10%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
diastolic dysfunction
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
dressler's syndrome
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
extrasystoles
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hypertensive heart disease
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
intracardiac thrombus
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ischaemic cardiomyopathy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
7 / 6036 (0.12%) |
10 / 6052 (0.17%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
left ventricular dysfunction
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
5 / 6036 (0.08%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
left ventricular failure
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
microvascular coronary artery disease
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
mitral valve incompetence
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
mitral valve stenosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
myocardial infarction
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
82 / 6036 (1.36%) |
100 / 6052 (1.65%) |
occurrences causally related to treatment / all
|
1 / 88 |
0 / 107 |
deaths causally related to treatment / all
|
0 / 14 |
0 / 17 |
myocardial ischaemia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
15 / 6036 (0.25%) |
9 / 6052 (0.15%) |
occurrences causally related to treatment / all
|
1 / 16 |
1 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
myocardial rupture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
nodal rhythm
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
palpitations
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
6 / 6036 (0.10%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pericardial effusion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pericardial haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
pericarditis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
5 / 6036 (0.08%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
postinfarction angina
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
prinzmetal angina
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
right ventricular failure
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
sinus arrest
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
sinus bradycardia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
sinus node dysfunction
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
12 / 6036 (0.20%) |
9 / 6052 (0.15%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
sinus tachycardia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
stress cardiomyopathy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
supraventricular tachycardia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
6 / 6052 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
systolic dysfunction
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
tachyarrhythmia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
tachycardia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ventricle rupture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ventricular arrhythmia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
ventricular extrasystoles
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ventricular fibrillation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
7 / 6036 (0.12%) |
10 / 6052 (0.17%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
ventricular hypokinesia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ventricular tachyarrhythmia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ventricular tachycardia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
16 / 6036 (0.27%) |
24 / 6052 (0.40%) |
occurrences causally related to treatment / all
|
0 / 21 |
0 / 24 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
wolff-parkinson-white syndrome
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
acute disseminated encephalomyelitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
amyotrophic lateral sclerosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
aphasia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ataxia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
autonomic nervous system imbalance
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
brain injury
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
brain mass
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
brain stem stroke
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
carotid arteriosclerosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
carotid artery disease
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
carotid artery occlusion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
carotid artery stenosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
21 / 6036 (0.35%) |
39 / 6052 (0.64%) |
occurrences causally related to treatment / all
|
0 / 21 |
0 / 42 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
carotid sinus syndrome
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
carpal tunnel syndrome
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cerebellar ischaemia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cerebral arteriosclerosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cerebellar syndrome
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cerebral artery occlusion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cerebral haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
cerebral infarction
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
5 / 6036 (0.08%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
2 / 5 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cerebral ischaemia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cerebrovascular insufficiency
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
cerebrovascular accident
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
61 / 6036 (1.01%) |
62 / 6052 (1.02%) |
occurrences causally related to treatment / all
|
0 / 63 |
0 / 65 |
deaths causally related to treatment / all
|
0 / 7 |
0 / 10 |
cervical myelopathy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cervical radiculopathy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cognitive disorder
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
complex partial seizures
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
complex regional pain syndrome
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
dementia alzheimer's type
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
dementia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
diabetic neuropathy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
6 / 6036 (0.10%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
dizziness
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
6 / 6036 (0.10%) |
6 / 6052 (0.10%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
embolic cerebral infarction
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
embolic stroke
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
encephalopathy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
epilepsy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
essential tremor
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
guillain-barre syndrome
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
haemorrhage intracranial
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
haemorrhagic stroke
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
5 / 6052 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
haemorrhagic transformation stroke
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
headache
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
7 / 6036 (0.12%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hemiparesis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hypoaesthesia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hypoglycaemic coma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hypoxic-ischaemic encephalopathy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
intraventricular haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ischaemic stroke
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
25 / 6036 (0.41%) |
18 / 6052 (0.30%) |
occurrences causally related to treatment / all
|
1 / 25 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
lacunar infarction
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
loss of consciousness
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lumbar radiculopathy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lumbosacral radiculopathy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
metabolic encephalopathy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
5 / 6052 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
migraine
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
5 / 6036 (0.08%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
moyamoya disease
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
myasthenia gravis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
myelitis transverse
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
myoclonus
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
nerve root compression
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
nerve compression
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
nervous system disorder
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
neuralgia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
neuropathy peripheral
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
normal pressure hydrocephalus
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
paraesthesia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
parkinson's disease
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
partial seizures
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
peroneal nerve palsy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
polyneuropathy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
post herpetic neuralgia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
postictal paralysis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
presyncope
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
8 / 6036 (0.13%) |
9 / 6052 (0.15%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
quadriparesis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
quadriplegia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
radicular syndrome
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
radiculopathy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
restless legs syndrome
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
sciatica
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
6 / 6036 (0.10%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
seizure
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
7 / 6036 (0.12%) |
6 / 6052 (0.10%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
spinal claudication
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
spinal cord compression
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
spinal cord infarction
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
spinal cord oedema
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
status epilepticus
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
subarachnoid haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
syncope
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
46 / 6036 (0.76%) |
52 / 6052 (0.86%) |
occurrences causally related to treatment / all
|
0 / 48 |
1 / 54 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
thalamus haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
thrombotic stroke
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
toxic encephalopathy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
transient global amnesia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
transient ischaemic attack
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
37 / 6036 (0.61%) |
39 / 6052 (0.64%) |
occurrences causally related to treatment / all
|
1 / 44 |
0 / 42 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
tremor
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
trigeminal neuralgia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
uraemic encephalopathy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
vascular encephalopathy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
vascular dementia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
vasogenic cerebral oedema
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
vertebral artery stenosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
vertebrobasilar insufficiency
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
vertigo cns origin
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
viith nerve paralysis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
vith nerve paresis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
vith nerve paralysis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
anaemia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
30 / 6036 (0.50%) |
38 / 6052 (0.63%) |
occurrences causally related to treatment / all
|
0 / 31 |
2 / 46 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
aplastic anaemia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
coagulopathy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cytopenia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
disseminated intravascular coagulation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
febrile neutropenia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
haemorrhagic anaemia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
5 / 6052 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
heparin-induced thrombocytopenia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
immune thrombocytopenic purpura
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
iron deficiency anaemia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
5 / 6052 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
leukocytosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lymphadenitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lymphadenopathy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lymphadenopathy mediastinal
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
microcytic anaemia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
normochromic normocytic anaemia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pancytopenia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pernicious anaemia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
splenic infarction
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
spontaneous haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
thrombocytopenia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
conductive deafness
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
deafness neurosensory
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ear pain
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
eustachian tube dysfunction
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
meniere's disease
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
otosclerosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
tinnitus
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
vertigo
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
7 / 6036 (0.12%) |
15 / 6052 (0.25%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
vertigo positional
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
5 / 6036 (0.08%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
age-related macular degeneration
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cataract
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
15 / 6036 (0.25%) |
14 / 6052 (0.23%) |
occurrences causally related to treatment / all
|
0 / 19 |
2 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cataract nuclear
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
conjunctival haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
diabetic retinopathy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
diplopia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ectropion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
entropion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
eye haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
eye pain
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
eyelid ptosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
glaucoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
idiopathic orbital inflammation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
iridocyclitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
iritis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
keratitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
keratopathy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lens dislocation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
macular fibrosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
open angle glaucoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
optic atrophy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
optic ischaemic neuropathy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
optic neuropathy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
retinal artery occlusion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
retinal detachment
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
retinal haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
retinopathy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
visual acuity reduced
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
visual impairment
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
vitreous haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
abdominal adhesions
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
abdominal compartment syndrome
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
abdominal distension
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
abdominal hernia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
abdominal mass
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
abdominal pain
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
18 / 6036 (0.30%) |
8 / 6052 (0.13%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
abdominal pain upper
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
5 / 6036 (0.08%) |
7 / 6052 (0.12%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
abdominal strangulated hernia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
abdominal wall cyst
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
abdominal wall haematoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
alcoholic pancreatitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
anal haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ascites
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
chronic gastritis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
coeliac artery stenosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
colitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
5 / 6036 (0.08%) |
9 / 6052 (0.15%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
colitis ischaemic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
6 / 6052 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
2 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
colitis microscopic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
colitis ulcerative
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
colonic fistula
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
constipation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
5 / 6036 (0.08%) |
8 / 6052 (0.13%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
crohn's disease
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
diarrhoea
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
6 / 6036 (0.10%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
dieulafoy's vascular malformation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
diverticular perforation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
diverticulum
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
diverticulum intestinal
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
diverticulum intestinal haemorrhagic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
5 / 6036 (0.08%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
duodenal ulcer
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
duodenal stenosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
duodenal ulcer haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
duodenal ulcer perforation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
duodenitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
dyspepsia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
dysphagia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
enteritis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
enterocolitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
enterovesical fistula
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
erosive oesophagitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
faecal incontinence
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
faecaloma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
femoral hernia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
food poisoning
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastric cyst
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastric disorder
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastric haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastric polyps
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastric ulcer
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
6 / 6036 (0.10%) |
7 / 6052 (0.12%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastric ulcer haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastritis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
10 / 6036 (0.17%) |
10 / 6052 (0.17%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastric ulcer perforation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastritis alcoholic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastritis erosive
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastritis haemorrhagic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
gastrointestinal angiodysplasia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastrointestinal angiodysplasia haemorrhagic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastrointestinal disorder
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastrointestinal haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
32 / 6036 (0.53%) |
26 / 6052 (0.43%) |
occurrences causally related to treatment / all
|
1 / 32 |
0 / 32 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
gastrointestinal inflammation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastrointestinal ulcer haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastrooesophageal reflux disease
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
13 / 6036 (0.22%) |
11 / 6052 (0.18%) |
occurrences causally related to treatment / all
|
1 / 13 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gingival bleeding
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
glossitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
haematemesis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
haematochezia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
haemorrhoidal haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
haemorrhoids
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
heyde's syndrome
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hiatus hernia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ileus
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
5 / 6036 (0.08%) |
5 / 6052 (0.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
impaired gastric emptying
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
inguinal hernia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
15 / 6036 (0.25%) |
13 / 6052 (0.21%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
intestinal haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
intestinal ischaemia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
5 / 6036 (0.08%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
intestinal infarction
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
intestinal obstruction
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
6 / 6052 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
intestinal perforation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
intestinal prolapse
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
intra-abdominal haematoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
intra-abdominal haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
irritable bowel syndrome
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
jejunal perforation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
large intestinal haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
large intestinal obstruction
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
large intestinal stenosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
large intestine perforation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
large intestine polyp
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
6 / 6036 (0.10%) |
11 / 6052 (0.18%) |
occurrences causally related to treatment / all
|
0 / 7 |
1 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
localised intraabdominal fluid collection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lower gastrointestinal haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
6 / 6036 (0.10%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
mallory-weiss syndrome
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
melaena
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
mesenteric vascular insufficiency
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
mouth haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
nausea
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
8 / 6036 (0.13%) |
6 / 6052 (0.10%) |
occurrences causally related to treatment / all
|
1 / 8 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
odynophagia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
oedematous pancreatitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
oesophageal achalasia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
oesophageal oedema
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
oesophageal spasm
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
oesophageal stenosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
oesophageal ulcer
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
oesophagitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pancreatic mass
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pancreatic pseudocyst
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pancreatitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
12 / 6036 (0.20%) |
10 / 6052 (0.17%) |
occurrences causally related to treatment / all
|
1 / 13 |
2 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pancreatitis acute
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
10 / 6036 (0.17%) |
6 / 6052 (0.10%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pancreatitis chronic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pancreatitis haemorrhagic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pancreatitis necrotising
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
peptic ulcer haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
peptic ulcer
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
peritoneal adhesions
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pneumoperitoneum
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
rectal haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
rectal polyp
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
rectal ulcer haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
retroperitoneal effusion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
retroperitoneal haematoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
retroperitoneal haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
salivary gland mass
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
small intestinal obstruction
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
11 / 6036 (0.18%) |
10 / 6052 (0.17%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
small intestinal perforation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
subileus
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
swollen tongue
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
tongue haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
tongue oedema
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
umbilical hernia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
6 / 6052 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
upper gastrointestinal haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
11 / 6036 (0.18%) |
10 / 6052 (0.17%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
volvulus
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
vomiting
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
9 / 6036 (0.15%) |
7 / 6052 (0.12%) |
occurrences causally related to treatment / all
|
1 / 12 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
angioedema
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
decubitus ulcer
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
dermal cyst
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
dermatomyositis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
diabetic foot
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
10 / 6036 (0.17%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
diabetic neuropathic ulcer
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
erythema multiforme
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
henoch-schonlein purpura
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hyperhidrosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hyperkeratosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hypersensitivity vasculitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
psoriasis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
rash
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
skin lesion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
skin ulcer
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
9 / 6036 (0.15%) |
5 / 6052 (0.08%) |
occurrences causally related to treatment / all
|
1 / 9 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
urticaria
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
vasculitic rash
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
acute kidney injury
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
48 / 6036 (0.80%) |
67 / 6052 (1.11%) |
occurrences causally related to treatment / all
|
0 / 58 |
2 / 81 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
acute prerenal failure
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
azotaemia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bladder outlet obstruction
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bladder prolapse
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
calculus ureteric
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
7 / 6036 (0.12%) |
9 / 6052 (0.15%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
calculus urinary
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
chronic kidney disease
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
9 / 6036 (0.15%) |
10 / 6052 (0.17%) |
occurrences causally related to treatment / all
|
1 / 10 |
3 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
cystitis haemorrhagic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cystitis ulcerative
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
diabetic nephropathy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
dysuria
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
glomerulonephritis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
glomerulosclerosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
haematuria
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
11 / 6036 (0.18%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hydronephrosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
5 / 6052 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hypotonic urinary bladder
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
nephrolithiasis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
19 / 6036 (0.31%) |
10 / 6052 (0.17%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
nephropathy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
nephrosclerosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
nephrotic syndrome
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
obstructive uropathy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pelvi-ureteric obstruction
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
prerenal failure
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
renal artery stenosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
5 / 6052 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
renal colic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
renal cyst
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
renal failure
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
14 / 6036 (0.23%) |
11 / 6052 (0.18%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
renal haematoma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
renal impairment
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
renal infarct
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
renal injury
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
renal tubular necrosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
renal vein thrombosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
stress urinary incontinence
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
tubulointerstitial nephritis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ureteral disorder
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
urethral haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
urethral stenosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
urinary bladder haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
urinary incontinence
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
urinary retention
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
9 / 6052 (0.15%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
urinary tract obstruction
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
autoimmune thyroiditis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
goitre
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hyperparathyroidism
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hyperparathyroidism primary
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
ankylosing spondylitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
arthralgia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
7 / 6036 (0.12%) |
17 / 6052 (0.28%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
arthritis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
9 / 6036 (0.15%) |
7 / 6052 (0.12%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
arthropathy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
back pain
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
15 / 6036 (0.25%) |
14 / 6052 (0.23%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bone pain
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bursitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cervical spinal stenosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
chondrocalcinosis pyrophosphate
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
compartment syndrome
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
costochondritis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
dupuytren's contracture
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
facet joint syndrome
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
fibromyalgia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
foot deformity
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gouty arthritis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
groin pain
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
haemarthrosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
intervertebral disc degeneration
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
7 / 6036 (0.12%) |
6 / 6052 (0.10%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
intervertebral disc disorder
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
6 / 6036 (0.10%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
intervertebral disc protrusion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
6 / 6036 (0.10%) |
14 / 6052 (0.23%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
joint instability
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
joint swelling
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
kyphosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ligament laxity
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lumbar spinal stenosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
13 / 6036 (0.22%) |
23 / 6052 (0.38%) |
occurrences causally related to treatment / all
|
0 / 13 |
1 / 24 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
mobility decreased
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
muscle haemorrhage
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
muscle spasms
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
muscular weakness
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
musculoskeletal chest pain
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
17 / 6036 (0.28%) |
15 / 6052 (0.25%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
musculoskeletal discomfort
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
musculoskeletal pain
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
5 / 6036 (0.08%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
musculoskeletal stiffness
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
myalgia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
neck pain
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
neuropathic arthropathy
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
osteitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
osteoarthritis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
70 / 6036 (1.16%) |
66 / 6052 (1.09%) |
occurrences causally related to treatment / all
|
0 / 76 |
1 / 75 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
osteochondrosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
osteonecrosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pain in extremity
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
7 / 6036 (0.12%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
2 / 7 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pain in jaw
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
polymyalgia rheumatica
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pseudarthrosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
rhabdomyolysis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
6 / 6036 (0.10%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
rheumatoid arthritis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
rotator cuff syndrome
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
8 / 6036 (0.13%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
scoliosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
spinal column stenosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
6 / 6036 (0.10%) |
10 / 6052 (0.17%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
spinal osteoarthritis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
5 / 6036 (0.08%) |
8 / 6052 (0.13%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
spinal pain
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
5 / 6036 (0.08%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
spondylolisthesis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
synovial cyst
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
synovitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
tendon disorder
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
tendonitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
trigger finger
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
vertebral foraminal stenosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
abdominal abscess
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
5 / 6052 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
abdominal infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
abdominal sepsis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
abdominal wall abscess
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
abdominal wall infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
abscess
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
abscess limb
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
abscess neck
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
abscess of salivary gland
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
abscess oral
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
acute sinusitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
anal abscess
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
appendicitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
9 / 6036 (0.15%) |
5 / 6052 (0.08%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
appendicitis perforated
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
arteriosclerotic gangrene
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
arteritis infective
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
arthritis bacterial
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
atypical pneumonia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bacterial infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bacteraemia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
6 / 6036 (0.10%) |
5 / 6052 (0.08%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bacterial sepsis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
biliary sepsis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
biliary tract infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
breast cellulitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bronchitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
25 / 6036 (0.41%) |
18 / 6052 (0.30%) |
occurrences causally related to treatment / all
|
0 / 25 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bronchitis viral
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bursitis infective
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cellulitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
41 / 6036 (0.68%) |
42 / 6052 (0.69%) |
occurrences causally related to treatment / all
|
0 / 48 |
0 / 45 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cellulitis staphylococcal
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cholangitis infective
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cholecystitis infective
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
5 / 6036 (0.08%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
chronic sinusitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
clostridium difficile colitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
8 / 6052 (0.13%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
clostridium difficile infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
clostridium difficile sepsis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
colonic abscess
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cystitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
6 / 6036 (0.10%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
device related infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
diabetic foot infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
diabetic gangrene
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
diverticulitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
13 / 6036 (0.22%) |
5 / 6052 (0.08%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
endocarditis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
endocarditis bacterial
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
endocarditis enterococcal
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
endophthalmitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
enterobacter infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
enterococcal bacteraemia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
enterococcal infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
enterococcal sepsis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
epididymitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [39]
|
1 / 4648 (0.02%) |
1 / 4658 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
erysipelas
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
6 / 6036 (0.10%) |
5 / 6052 (0.08%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
escherichia bacteraemia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
escherichia infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
escherichia pyelonephritis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
escherichia sepsis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
escherichia urinary tract infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
extradural abscess
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
febrile infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
folliculitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gallbladder abscess
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gallbladder empyema
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gangrene
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
7 / 6036 (0.12%) |
11 / 6052 (0.18%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastritis viral
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastroenteritis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
16 / 6036 (0.27%) |
16 / 6052 (0.26%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastroenteritis norovirus
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastroenteritis viral
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
8 / 6036 (0.13%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
giardiasis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
graft infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
groin abscess
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
h1n1 influenza
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
haematoma infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hepatitis c
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hepatitis viral
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
herpes zoster
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
implant site cellulitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
implant site infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
incision site infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
infected bite
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
infected fistula
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
infected seroma
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
infected skin ulcer
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
infectious colitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
infectious pleural effusion
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
infective exacerbation of chronic obstructive airways disease
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
influenza
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
11 / 6036 (0.18%) |
9 / 6052 (0.15%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
infusion site cellulitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
infusion site infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
intervertebral discitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
keratitis bacterial
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
klebsiella sepsis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
liver abscess
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
localised infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lower respiratory tract infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
7 / 6052 (0.12%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
lung abscess
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lung infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
mastoiditis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
mediastinitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
myelitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
nail bed infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
necrotising fasciitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
oesophageal candidiasis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
orbital infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
osteomyelitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
13 / 6036 (0.22%) |
5 / 6052 (0.08%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
osteomyelitis acute
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
osteomyelitis bacterial
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
osteomyelitis chronic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
parainfluenzae virus infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
parotitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
parvovirus infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pelvic abscess
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
penile abscess
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed [40]
|
1 / 4648 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
perihepatic abscess
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
periodontitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
perirectal abscess
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
peritonitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
peritonitis bacterial
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
peritonsillar abscess
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pharyngitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pilonidal cyst
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pneumonia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
115 / 6036 (1.91%) |
112 / 6052 (1.85%) |
occurrences causally related to treatment / all
|
0 / 128 |
0 / 122 |
deaths causally related to treatment / all
|
0 / 7 |
0 / 4 |
pneumonia bacterial
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
6 / 6052 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pneumonia chlamydial
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pneumonia fungal
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pneumonia influenzal
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pneumonia legionella
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pneumonia parainfluenzae viral
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pneumonia pneumococcal
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pneumonia staphylococcal
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
pneumonia streptococcal
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pneumonia viral
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
post procedural cellulitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
post procedural infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
post procedural sepsis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
postoperative abscess
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
postoperative wound infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
6 / 6052 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pulmonary sepsis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
pulmonary tuberculosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pyelonephritis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
7 / 6036 (0.12%) |
4 / 6052 (0.07%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pyelonephritis acute
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pyelonephritis chronic
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
respiratory syncytial virus infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
respiratory tract infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
respiratory tract infection viral
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
rhinovirus infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
salmonellosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
sepsis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
44 / 6036 (0.73%) |
28 / 6052 (0.46%) |
occurrences causally related to treatment / all
|
0 / 49 |
0 / 32 |
deaths causally related to treatment / all
|
0 / 7 |
0 / 7 |
septic shock
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
10 / 6036 (0.17%) |
7 / 6052 (0.12%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 3 |
sialoadenitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
sinusitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
sinusitis fungal
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
skin candida
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
soft tissue infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
spinal cord abscess
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
staphylococcal bacteraemia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
staphylococcal infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
6 / 6036 (0.10%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
staphylococcal mediastinitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
staphylococcal sepsis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
streptococcal sepsis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
streptococcal bacteraemia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
subcutaneous abscess
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
tooth infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
tracheobronchitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
upper respiratory tract infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
urinary tract infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
19 / 6036 (0.31%) |
32 / 6052 (0.53%) |
occurrences causally related to treatment / all
|
0 / 22 |
0 / 36 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
urinary tract infection bacterial
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
urinary tract infection pseudomonal
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
urosepsis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
16 / 6036 (0.27%) |
14 / 6052 (0.23%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
vestibular neuronitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
viral infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
3 / 6052 (0.05%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
viral labyrinthitis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
wound abscess
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
wound infection
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
7 / 6052 (0.12%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
wound infection bacterial
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
wound infection staphylococcal
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
decreased appetite
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
dehydration
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
15 / 6036 (0.25%) |
26 / 6052 (0.43%) |
occurrences causally related to treatment / all
|
1 / 15 |
0 / 28 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
diabetes mellitus
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
11 / 6036 (0.18%) |
20 / 6052 (0.33%) |
occurrences causally related to treatment / all
|
0 / 11 |
1 / 22 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
diabetes mellitus inadequate control
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
8 / 6036 (0.13%) |
14 / 6052 (0.23%) |
occurrences causally related to treatment / all
|
0 / 9 |
1 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
diabetic ketoacidosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
3 / 6036 (0.05%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
diabetic metabolic decompensation
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
electrolyte imbalance
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
failure to thrive
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
fluid overload
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gout
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
6 / 6052 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hypercalcaemia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hyperglycaemia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
13 / 6036 (0.22%) |
10 / 6052 (0.17%) |
occurrences causally related to treatment / all
|
0 / 13 |
1 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hyperkalaemia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
9 / 6036 (0.15%) |
9 / 6052 (0.15%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
hyperosmolar hyperglycaemic state
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hypoglycaemia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
17 / 6036 (0.28%) |
18 / 6052 (0.30%) |
occurrences causally related to treatment / all
|
1 / 17 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hypokalaemia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
4 / 6036 (0.07%) |
7 / 6052 (0.12%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hypomagnesaemia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hyponatraemia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
6 / 6036 (0.10%) |
9 / 6052 (0.15%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hypovolaemia
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
2 / 6052 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ketoacidosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lactic acidosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
malnutrition
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
1 / 6036 (0.02%) |
0 / 6052 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
metabolic acidosis
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
2 / 6036 (0.03%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
obesity
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
5 / 6036 (0.08%) |
5 / 6052 (0.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
type 2 diabetes mellitus
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
6 / 6036 (0.10%) |
6 / 6052 (0.10%) |
occurrences causally related to treatment / all
|
4 / 6 |
2 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
vitamin b12 deficiency
|
|
|
alternative dictionary used: MedDRA
15.1
|
|
|
subjects affected / exposed
|
0 / 6036 (0.00%) |
1 / 6052 (0.02%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |