Serious adverse events
|
Solanezumab 400mg: Solanezumab 400mg Open Label |
Placebo: Solanezumab 400mg Open Label |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
299 / 734 (40.74%) |
308 / 723 (42.60%) |
number of deaths (all causes)
|
43 |
39 |
number of deaths resulting from adverse events
|
3 |
4 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
adenocarcinoma of colon
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (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
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
benign soft tissue neoplasm
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bladder cancer
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
2 / 734 (0.27%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
1 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bladder cancer recurrent
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
2 / 734 (0.27%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bladder transitional cell carcinoma
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
brain neoplasm
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
breast cancer
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
3 / 734 (0.41%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
2 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
breast cancer metastatic
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
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
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
colon cancer
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
colon cancer metastatic
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
essential thrombocythaemia
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastric cancer
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
2 / 734 (0.27%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
granular cell tumour
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
invasive ductal breast carcinoma
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lung cancer metastatic
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
lung carcinoma cell type unspecified stage iv
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
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
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lymphoma
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
malignant melanoma
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
malignant neoplasm of unknown primary site
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
malignant neoplasm progression
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
metastases to liver
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
metastatic malignant melanoma
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
neoplasm
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
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
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
3 / 723 (0.41%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
oesophageal adenocarcinoma
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pancreatic carcinoma
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
pancreatic carcinoma metastatic
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pancreatic neoplasm
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
papillary thyroid cancer
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
plasma cell myeloma
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
plasmacytoma
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
prostate cancer metastatic
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed [1]
|
1 / 319 (0.31%) |
0 / 317 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
rectal cancer
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (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
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
renal neoplasm
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
salivary gland neoplasm
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
squamous cell carcinoma of skin
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
uterine cancer
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed [2]
|
0 / 415 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Vascular disorders
|
|
|
aortic aneurysm
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
aortic stenosis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
arterial thrombosis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (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
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
deep vein thrombosis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
6 / 734 (0.82%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
haematoma
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hypertensive crisis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hypotension
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
peripheral artery thrombosis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
peripheral ischaemia
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
shock
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
thromboangiitis obliterans
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
thrombophlebitis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
venous thrombosis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
cataract operation
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
abasia
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
adverse drug reaction
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
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
19.0
|
|
|
subjects affected / exposed
|
2 / 734 (0.27%) |
5 / 723 (0.69%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
catheter site haemorrhage
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
chest pain
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
complication associated with device
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
death
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
4 / 723 (0.55%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 4 |
drowning
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
gait disturbance
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
general physical health deterioration
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
non-cardiac chest pain
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
oedema peripheral
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pain
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pyrexia
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
3 / 734 (0.41%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
sudden death
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
3 / 723 (0.41%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
Social circumstances
|
|
|
activities of daily living impaired
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
acquired hydrocele
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed [3]
|
1 / 319 (0.31%) |
0 / 317 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
acute pulmonary oedema
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
acute respiratory failure
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
aspiration
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
benign prostatic hyperplasia
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed [4]
|
1 / 319 (0.31%) |
2 / 317 (0.63%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bronchospasm
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
chronic obstructive pulmonary disease
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cystocele
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed [5]
|
0 / 415 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
dyspnoea
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
3 / 723 (0.41%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hypoxia
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
interstitial lung disease
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
lung disorder
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
nasal polyps
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
organising pneumonia
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pharyngeal oedema
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pleural effusion
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
4 / 723 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pneumonia aspiration
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
5 / 734 (0.68%) |
5 / 723 (0.69%) |
occurrences causally related to treatment / all
|
2 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
pneumothorax
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pneumothorax spontaneous
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
prostatomegaly
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed [6]
|
1 / 319 (0.31%) |
0 / 317 (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
19.0
|
|
|
subjects affected / exposed
|
6 / 734 (0.82%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
respiratory distress
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
respiratory failure
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
3 / 734 (0.41%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
1 / 1 |
uterine prolapse
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed [7]
|
0 / 415 (0.00%) |
1 / 406 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
abnormal behaviour
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
affective disorder
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (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
19.0
|
|
|
subjects affected / exposed
|
2 / 734 (0.27%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 7 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
agitation
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
7 / 734 (0.95%) |
11 / 723 (1.52%) |
occurrences causally related to treatment / all
|
0 / 7 |
1 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
alcohol abuse
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
behavioural and psychiatric symptoms of dementia
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
3 / 734 (0.41%) |
7 / 723 (0.97%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bipolar disorder
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
completed suicide
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
confusional state
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
6 / 734 (0.82%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
2 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
delirium
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
5 / 734 (0.68%) |
5 / 723 (0.69%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
delirium febrile
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
delusion
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
2 / 734 (0.27%) |
3 / 723 (0.41%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
delusional perception
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
disorientation
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
insomnia
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
irritability
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
3 / 723 (0.41%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
major depression
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
mental status changes
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
2 / 734 (0.27%) |
5 / 723 (0.69%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
restlessness
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
suicidal behaviour
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
suicidal ideation
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
suicide attempt
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigations
|
|
|
blood pressure increased
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hepatic enzyme increased
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
acetabulum fracture
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ankle fracture
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bone contusion
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (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
19.0
|
|
|
subjects affected / exposed
|
2 / 734 (0.27%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
clavicle fracture
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
concussion
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
3 / 723 (0.41%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
contusion
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
craniocerebral injury
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
facial bones fracture
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
fall
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
23 / 734 (3.13%) |
27 / 723 (3.73%) |
occurrences causally related to treatment / all
|
0 / 25 |
0 / 27 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
femoral neck fracture
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
13 / 734 (1.77%) |
4 / 723 (0.55%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
femur fracture
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
3 / 734 (0.41%) |
11 / 723 (1.52%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
fibula fracture
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
flail chest
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
foot fracture
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
forearm fracture
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
fractured ischium
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
head injury
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
2 / 734 (0.27%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hip fracture
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
11 / 734 (1.50%) |
8 / 723 (1.11%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
humerus fracture
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
4 / 723 (0.55%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
incisional hernia
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
injury
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
joint dislocation
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
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
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
laceration
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
3 / 723 (0.41%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ligament sprain
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lumbar vertebral fracture
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
patella fracture
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pelvic fracture
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
4 / 734 (0.54%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
periprosthetic fracture
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (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
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pulmonary contusion
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
radius fracture
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
2 / 734 (0.27%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
rib fracture
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
3 / 723 (0.41%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
road traffic accident
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
skull fracture
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
spinal column injury
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
spinal compression fracture
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
2 / 734 (0.27%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
spinal fracture
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
subdural haematoma
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
5 / 734 (0.68%) |
4 / 723 (0.55%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
subdural haemorrhage
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
1 / 723 (0.14%) |
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
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
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
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
traumatic intracranial haemorrhage
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
upper limb fracture
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
wound
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
wound dehiscence
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (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
19.0
|
|
|
subjects affected / exposed
|
2 / 734 (0.27%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
acute myocardial infarction
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
4 / 734 (0.54%) |
4 / 723 (0.55%) |
occurrences causally related to treatment / all
|
1 / 5 |
2 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
angina pectoris
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
4 / 734 (0.54%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 5 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
arrhythmia supraventricular
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
atrial fibrillation
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
9 / 734 (1.23%) |
5 / 723 (0.69%) |
occurrences causally related to treatment / all
|
6 / 9 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
atrial flutter
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
atrioventricular block
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
2 / 734 (0.27%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
1 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
atrioventricular block second degree
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bradycardia
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
2 / 734 (0.27%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
1 / 2 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cardiac arrest
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
5 / 734 (0.68%) |
5 / 723 (0.69%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 5 |
cardiac failure
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
3 / 734 (0.41%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
2 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
cardiac failure acute
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
2 / 734 (0.27%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
cardiac failure congestive
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
5 / 734 (0.68%) |
6 / 723 (0.83%) |
occurrences causally related to treatment / all
|
0 / 5 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
cardiac perforation
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cardio-respiratory arrest
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
2 / 734 (0.27%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
cardiogenic shock
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
cardiomyopathy
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
cardiopulmonary failure
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
cardiovascular disorder
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
coronary artery stenosis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
myocardial infarction
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
4 / 734 (0.54%) |
5 / 723 (0.69%) |
occurrences causally related to treatment / all
|
1 / 4 |
2 / 5 |
deaths causally related to treatment / all
|
1 / 3 |
1 / 1 |
palpitations
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pericardial effusion
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
sinus bradycardia
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
sinus node dysfunction
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
4 / 723 (0.55%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
tachycardia
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ventricular extrasystoles
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (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
|
|
|
altered state of consciousness
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
brain stem haemorrhage
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
brain stem infarction
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cerebral haematoma
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cerebral haemorrhage
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
3 / 723 (0.41%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
cerebral infarction
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
4 / 734 (0.54%) |
3 / 723 (0.41%) |
occurrences causally related to treatment / all
|
3 / 4 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cerebral microhaemorrhage
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cerebrospinal fluid leakage
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cerebrovascular accident
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
3 / 734 (0.41%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
1 / 1 |
circadian rhythm sleep disorder
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cognitive disorder
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
3 / 734 (0.41%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
coma
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
complex partial seizures
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
dementia alzheimer's type
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
5 / 734 (0.68%) |
8 / 723 (1.11%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
dementia with lewy bodies
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
depressed level of consciousness
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
dizziness
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
encephalopathy
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
3 / 723 (0.41%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
epilepsy
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
generalised tonic-clonic seizure
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
haemorrhage intracranial
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
haemorrhagic cerebral infarction
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
haemorrhagic stroke
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
headache
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
3 / 723 (0.41%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hemiparesis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
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
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
intracranial aneurysm
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
intraventricular haemorrhage
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
ischaemic cerebral infarction
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ischaemic stroke
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
6 / 723 (0.83%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
lethargy
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
2 / 734 (0.27%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
loss of consciousness
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
metabolic encephalopathy
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
myoclonus
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
1 / 723 (0.14%) |
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
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
presyncope
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
2 / 734 (0.27%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
seizure
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
11 / 734 (1.50%) |
3 / 723 (0.41%) |
occurrences causally related to treatment / all
|
3 / 13 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
somnolence
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
2 / 734 (0.27%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
subarachnoid haemorrhage
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
syncope
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
15 / 734 (2.04%) |
10 / 723 (1.38%) |
occurrences causally related to treatment / all
|
1 / 16 |
1 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
transient ischaemic attack
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
2 / 734 (0.27%) |
3 / 723 (0.41%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
tremor
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
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
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
anaemia
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
2 / 734 (0.27%) |
3 / 723 (0.41%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
anaemia folate deficiency
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
coagulopathy
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
normochromic normocytic anaemia
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
vertigo
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
cataract
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
2 / 734 (0.27%) |
3 / 723 (0.41%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
glaucoma
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
retinal detachment
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
strabismus
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
vitreous haemorrhage
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
abdominal hernia
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
abdominal pain
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
3 / 723 (0.41%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
abdominal pain upper
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
colitis ischaemic
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
colonic fistula
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
colonic pseudo-obstruction
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
constipation
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
diarrhoea
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
4 / 723 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
diarrhoea haemorrhagic
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
diverticular fistula
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
diverticulum
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
duodenal ulcer
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
2 / 734 (0.27%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
dyspepsia
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
dysphagia
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
erosive oesophagitis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
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
19.0
|
|
|
subjects affected / exposed
|
3 / 734 (0.41%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastric ulcer
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastric ulcer haemorrhage
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastritis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
2 / 734 (0.27%) |
0 / 723 (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
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
1 / 723 (0.14%) |
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
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
haematochezia
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
2 / 734 (0.27%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
haemorrhoids
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (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
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ileus
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
ileus paralytic
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
inguinal hernia
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
4 / 734 (0.54%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
intestinal obstruction
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
3 / 734 (0.41%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
jejunal perforation
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
large intestine polyp
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lower gastrointestinal haemorrhage
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
oesophageal perforation
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
oesophageal ulcer haemorrhage
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pancreatitis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
3 / 734 (0.41%) |
5 / 723 (0.69%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pancreatitis acute
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
2 / 734 (0.27%) |
0 / 723 (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
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
rectal prolapse
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
rectal ulcer haemorrhage
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (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
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
3 / 723 (0.41%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
small intestinal perforation
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
subileus
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
upper gastrointestinal haemorrhage
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
3 / 734 (0.41%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
vomiting
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
bile duct obstruction
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bile duct stone
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cholangitis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cholecystitis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cholecystitis acute
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
2 / 734 (0.27%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cholelithiasis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
drug-induced liver injury
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gallbladder polyp
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
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
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
dermatitis contact
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
diabetic foot
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
drug eruption
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hypersensitivity vasculitis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
sebaceous gland disorder
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
urticaria
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
acute kidney injury
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
2 / 734 (0.27%) |
6 / 723 (0.83%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
acute prerenal failure
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bladder tamponade
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
calculus bladder
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
haematuria
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
hydronephrosis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (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
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
renal failure
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
urinary bladder haemorrhage
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
urinary retention
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
3 / 734 (0.41%) |
3 / 723 (0.41%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
myxoedema
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
arthralgia
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
arthritis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
arthropathy
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
back pain
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
2 / 734 (0.27%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cervical spinal stenosis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
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
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
foot deformity
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gouty arthritis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
intervertebral disc protrusion
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
joint effusion
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (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
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (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
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
muscle spasms
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
muscular weakness
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
osteoarthritis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
13 / 734 (1.77%) |
7 / 723 (0.97%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
osteolysis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
rhabdomyolysis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
rotator cuff syndrome
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
2 / 734 (0.27%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
spinal column stenosis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
spondylolisthesis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
abdominal abscess
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
appendicitis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
2 / 734 (0.27%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
arthritis bacterial
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (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
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (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
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
bronchitis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
5 / 734 (0.68%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
campylobacter gastroenteritis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cellulitis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
7 / 734 (0.95%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
clostridium difficile colitis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
clostridium difficile infection
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
colostomy infection
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
cystitis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
2 / 734 (0.27%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
device related infection
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
diverticulitis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
3 / 734 (0.41%) |
4 / 723 (0.55%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
erysipelas
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (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
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
escherichia urinary tract infection
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
extradural abscess
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastroenteritis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
gastroenteritis viral
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
3 / 734 (0.41%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
groin abscess
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
herpes simplex encephalitis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
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
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
infected skin ulcer
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
influenza
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
4 / 734 (0.54%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
labyrinthitis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lower respiratory tract infection
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
lung infection
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
mediastinitis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
meningitis bacterial
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
orchitis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed [8]
|
1 / 319 (0.31%) |
0 / 317 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pericarditis tuberculous
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pharyngitis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pneumonia
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
27 / 734 (3.68%) |
27 / 723 (3.73%) |
occurrences causally related to treatment / all
|
1 / 31 |
1 / 31 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
pneumonia bacterial
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (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
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
post procedural infection
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
postoperative wound infection
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
pulmonary sepsis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
3 / 723 (0.41%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
pulmonary tuberculosis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
respiratory tract infection
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
sepsis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
6 / 734 (0.82%) |
3 / 723 (0.41%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
septic shock
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
2 / 723 (0.28%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
sinusitis
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
tooth abscess
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
upper respiratory tract infection
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
2 / 734 (0.27%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
urinary tract infection
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
17 / 734 (2.32%) |
16 / 723 (2.21%) |
occurrences causally related to treatment / all
|
1 / 19 |
1 / 21 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
urinary tract infection bacterial
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
urinary tract infection staphylococcal
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
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
19.0
|
|
|
subjects affected / exposed
|
5 / 734 (0.68%) |
3 / 723 (0.41%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
viral infection
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
wound infection
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
adult failure to thrive
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
decreased appetite
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
2 / 734 (0.27%) |
3 / 723 (0.41%) |
occurrences causally related to treatment / all
|
0 / 2 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
dehydration
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
13 / 734 (1.77%) |
7 / 723 (0.97%) |
occurrences causally related to treatment / all
|
1 / 15 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
diabetes mellitus
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
failure to thrive
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
gout
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hyperammonaemia
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hyperglycaemia
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hyperkalaemia
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hypernatraemia
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hyperosmolar hyperglycaemic state
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hypoglycaemia
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
0 / 734 (0.00%) |
4 / 723 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hyponatraemia
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
hypophagia
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
malnutrition
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
2 / 734 (0.27%) |
1 / 723 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
type 2 diabetes mellitus
|
|
|
alternative dictionary used: MedDRA
19.0
|
|
|
subjects affected / exposed
|
1 / 734 (0.14%) |
0 / 723 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |