Serious adverse events
|
2 mg Baricitinib |
4 mg Baricitinib |
2 mg Baricitinib Step-Down |
4 mg Baricitinib Step-Down |
Total subjects affected by serious adverse events
|
|
|
|
|
subjects affected / exposed
|
112 / 297 (37.71%) |
517 / 2579 (20.05%) |
164 / 592 (27.70%) |
178 / 594 (29.97%) |
number of deaths (all causes)
|
7 |
43 |
14 |
14 |
number of deaths resulting from adverse events
|
1 |
11 |
4 |
5 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
|
adenocarcinoma of colon
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
adenocarcinoma pancreas
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
anaplastic meningioma
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
angiolipoma
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
basal cell carcinoma
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
benign neoplasm of skin
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
benign neoplasm of thyroid gland
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
bladder cancer
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
1 / 2579 (0.04%) |
2 / 592 (0.34%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
2 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
bowen's disease
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
brain neoplasm
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
breast cancer
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
1 / 592 (0.17%) |
2 / 594 (0.34%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
1 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
breast cancer metastatic
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
3 / 2579 (0.12%) |
1 / 592 (0.17%) |
2 / 594 (0.34%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 3 |
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
cervix carcinoma
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [1]
|
0 / 231 (0.00%) |
1 / 2031 (0.05%) |
1 / 440 (0.23%) |
0 / 448 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
cervix carcinoma stage 0
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [2]
|
0 / 231 (0.00%) |
1 / 2031 (0.05%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
clear cell renal cell carcinoma
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
colon adenoma
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
colon cancer
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
colorectal cancer stage iv
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
diffuse large b-cell lymphoma
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
4 / 2579 (0.16%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
3 / 4 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
extranodal marginal zone b-cell lymphoma (malt type)
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
fibrous histiocytoma
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
gallbladder cancer
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
gastric cancer
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
2 / 594 (0.34%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
gastric neoplasm
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
giant cell tumour of tendon sheath
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
intraductal proliferative breast lesion
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
invasive ductal breast carcinoma
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
2 / 297 (0.67%) |
4 / 2579 (0.16%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
1 / 4 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
large granular lymphocytosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
3 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
large intestine fibroma
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
laryngeal cancer
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
lentigo maligna
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
leukaemia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
lipoma
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
4 / 2579 (0.16%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
lung adenocarcinoma
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
3 / 2579 (0.12%) |
2 / 592 (0.34%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
lung adenocarcinoma stage iv
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
lung cancer metastatic
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
lung neoplasm
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
lung neoplasm malignant
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
3 / 2579 (0.12%) |
2 / 592 (0.34%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 3 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
1 / 2 |
0 / 0 |
lung squamous cell carcinoma metastatic
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
lymphocytic leukaemia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
lymphoproliferative disorder
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
2 / 592 (0.34%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
3 / 3 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
malignant fibrous histiocytoma
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
malignant glioma
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
malignant melanoma
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
2 / 594 (0.34%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
3 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
malignant melanoma in situ
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
malignant peritoneal neoplasm
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
malignant pleural effusion
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
meningioma
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
metastases to central nervous system
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
metastases to peritoneum
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
metastatic gastric cancer
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
mucoepidermoid carcinoma
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
mueller's mixed tumour
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [3]
|
0 / 231 (0.00%) |
1 / 2031 (0.05%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
neoplasm malignant
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
neuroendocrine carcinoma of the skin
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
non-hodgkin's lymphoma
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
non-small cell lung cancer metastatic
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
nonkeratinising carcinoma of nasopharynx
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
oesophageal squamous cell carcinoma
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
oral neoplasm benign
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
ovarian adenoma
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [4]
|
0 / 231 (0.00%) |
1 / 2031 (0.05%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
ovarian cancer
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [5]
|
1 / 231 (0.43%) |
2 / 2031 (0.10%) |
0 / 440 (0.00%) |
1 / 448 (0.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
ovarian cancer stage iv
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [6]
|
0 / 231 (0.00%) |
1 / 2031 (0.05%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
ovarian germ cell teratoma benign
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [7]
|
1 / 231 (0.43%) |
0 / 2031 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
paget's disease of nipple
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
pancreatic carcinoma
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
pancreatic carcinoma metastatic
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
pancreatic carcinoma stage iv
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
papillary cystadenoma lymphomatosum
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
papillary thyroid cancer
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
prostate cancer
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [8]
|
1 / 66 (1.52%) |
3 / 548 (0.55%) |
2 / 152 (1.32%) |
0 / 146 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 3 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
prostate cancer metastatic
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [9]
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 152 (0.00%) |
1 / 146 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
prostatic adenoma
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [10]
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 152 (0.00%) |
1 / 146 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
rectal cancer
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
renal cancer
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
renal cell carcinoma
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
skin cancer
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
small cell lung cancer metastatic
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
squamous cell carcinoma
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
squamous cell carcinoma of lung
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
squamous cell carcinoma of skin
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
squamous cell carcinoma of the cervix
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [11]
|
0 / 231 (0.00%) |
1 / 2031 (0.05%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
squamous cell carcinoma of the parotid gland
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
t-cell lymphoma
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
thyroid cancer stage i
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
uterine cancer
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [12]
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 440 (0.23%) |
0 / 448 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
uterine carcinoma in situ
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [13]
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 440 (0.23%) |
0 / 448 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
uterine leiomyoma
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [14]
|
0 / 231 (0.00%) |
2 / 2031 (0.10%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
|
|
aortic arteriosclerosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deep vein thrombosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
4 / 297 (1.35%) |
14 / 2579 (0.54%) |
2 / 592 (0.34%) |
4 / 594 (0.67%) |
occurrences causally related to treatment / all
|
0 / 4 |
5 / 16 |
2 / 3 |
4 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
embolism arterial
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
essential hypertension
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
haematoma
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
2 / 297 (0.67%) |
3 / 2579 (0.12%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
haemorrhage
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
hypertension
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
hypertensive crisis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
hypotension
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
hypovolaemic shock
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
intermittent claudication
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
jugular vein thrombosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
necrosis ischaemic
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
peripheral artery stenosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
peripheral ischaemia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
peripheral venous disease
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
rheumatoid vasculitis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
thrombophlebitis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
thrombosed varicose vein
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
varicose vein
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
vasculitis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
venous thrombosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
venous thrombosis limb
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
|
|
arthrodesis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
cataract operation
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
finger amputation
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
hysterectomy
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [15]
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 440 (0.23%) |
0 / 448 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
internal fixation of fracture
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
joint arthroplasty
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
knee arthroplasty
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
2 / 297 (0.67%) |
3 / 2579 (0.12%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
limb reconstructive surgery
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
rehabilitation therapy
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
scar excision
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
shoulder arthroplasty
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
vaginal cyst excision
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [16]
|
0 / 231 (0.00%) |
1 / 2031 (0.05%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pregnancy, puerperium and perinatal conditions
|
|
|
|
|
abortion spontaneous
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [17]
|
1 / 231 (0.43%) |
2 / 2031 (0.10%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
pregnancy
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [18]
|
0 / 231 (0.00%) |
1 / 2031 (0.05%) |
1 / 440 (0.23%) |
0 / 448 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
|
|
adverse drug reaction
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
alcohol interaction
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
chest pain
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
3 / 2579 (0.12%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
complication associated with device
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
death
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 1 |
exercise tolerance decreased
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
general physical health deterioration
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
mucosal inflammation
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
multiple organ dysfunction syndrome
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
non-cardiac chest pain
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
2 / 297 (0.67%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
pain
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
pyrexia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
2 / 297 (0.67%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
2 / 4 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
sudden cardiac death
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
systemic inflammatory response syndrome
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
|
|
anaphylactic reaction
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
hypersensitivity
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Social circumstances
|
|
|
|
|
respite care
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
|
|
adnexa uteri cyst
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [19]
|
0 / 231 (0.00%) |
2 / 2031 (0.10%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
bartholin's cyst
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [20]
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 440 (0.00%) |
1 / 448 (0.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
benign prostatic hyperplasia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [21]
|
0 / 66 (0.00%) |
1 / 548 (0.18%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
cervical cyst
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [22]
|
0 / 231 (0.00%) |
1 / 2031 (0.05%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
cervical dysplasia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [23]
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
2 / 440 (0.45%) |
1 / 448 (0.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
dysfunctional uterine bleeding
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [24]
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 440 (0.00%) |
1 / 448 (0.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
endometrial hyperplasia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [25]
|
0 / 231 (0.00%) |
1 / 2031 (0.05%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
endometrial hypertrophy
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [26]
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 440 (0.00%) |
1 / 448 (0.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
endometriosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [27]
|
0 / 231 (0.00%) |
1 / 2031 (0.05%) |
2 / 440 (0.45%) |
0 / 448 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
genital prolapse
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
metrorrhagia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [28]
|
0 / 231 (0.00%) |
4 / 2031 (0.20%) |
0 / 440 (0.00%) |
1 / 448 (0.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
ovarian cyst
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [29]
|
0 / 231 (0.00%) |
3 / 2031 (0.15%) |
0 / 440 (0.00%) |
1 / 448 (0.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
pelvic pain
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
testicular cyst
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [30]
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 152 (0.00%) |
1 / 146 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
uterine polyp
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [31]
|
0 / 231 (0.00%) |
1 / 2031 (0.05%) |
0 / 440 (0.00%) |
1 / 448 (0.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
uterine prolapse
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [32]
|
1 / 231 (0.43%) |
0 / 2031 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
vaginal haemorrhage
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [33]
|
1 / 231 (0.43%) |
0 / 2031 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
vaginal prolapse
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [34]
|
0 / 231 (0.00%) |
1 / 2031 (0.05%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
|
acute pulmonary oedema
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
acute respiratory distress syndrome
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
acute respiratory failure
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
5 / 2579 (0.19%) |
0 / 592 (0.00%) |
2 / 594 (0.34%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
1 / 2 |
allergic bronchitis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
asthma
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
4 / 2579 (0.16%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
atelectasis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
bronchitis chronic
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
bronchopneumopathy
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
bronchospasm
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
chronic obstructive pulmonary disease
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
9 / 2579 (0.35%) |
2 / 592 (0.34%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
3 / 3 |
2 / 17 |
0 / 11 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
cough
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
interstitial lung disease
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
5 / 2579 (0.19%) |
1 / 592 (0.17%) |
2 / 594 (0.34%) |
occurrences causally related to treatment / all
|
0 / 0 |
3 / 6 |
0 / 1 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
lung disorder
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
nasal polyps
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
obstructive airways disorder
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
organising pneumonia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
3 / 2579 (0.12%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
pleural effusion
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
3 / 2579 (0.12%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 3 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
pleurisy
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
pneumonia aspiration
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
1 / 2579 (0.04%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
pneumonitis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
pneumothorax
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
pulmonary arterial hypertension
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
pulmonary embolism
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
5 / 297 (1.68%) |
18 / 2579 (0.70%) |
5 / 592 (0.84%) |
3 / 594 (0.51%) |
occurrences causally related to treatment / all
|
4 / 8 |
6 / 21 |
1 / 5 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 2 |
0 / 0 |
pulmonary hypertension
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
pulmonary mass
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
pulmonary oedema
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
2 / 594 (0.34%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
respiratory arrest
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
respiratory failure
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
6 / 2579 (0.23%) |
0 / 592 (0.00%) |
2 / 594 (0.34%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 7 |
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
sleep apnoea syndrome
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
vocal cord polyp
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
|
|
anxiety
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
confusional state
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
depressed mood
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
depression
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
3 / 2579 (0.12%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
mental disorder
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
mental status changes
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
suicidal ideation
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
suicide attempt
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Product issues
|
|
|
|
|
device dislocation
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
device failure
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
device loosening
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
3 / 2579 (0.12%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
|
|
bile duct stone
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
1 / 592 (0.17%) |
2 / 594 (0.34%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
biliary colic
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
biliary obstruction
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
cholangitis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
cholecystitis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
2 / 297 (0.67%) |
4 / 2579 (0.16%) |
3 / 592 (0.51%) |
3 / 594 (0.51%) |
occurrences causally related to treatment / all
|
0 / 2 |
2 / 5 |
0 / 3 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
cholecystitis acute
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
4 / 2579 (0.16%) |
0 / 592 (0.00%) |
2 / 594 (0.34%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 4 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
cholecystitis chronic
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
cholelithiasis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
8 / 2579 (0.31%) |
1 / 592 (0.17%) |
10 / 594 (1.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 9 |
0 / 1 |
2 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
gallbladder polyp
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
hepatic cirrhosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
liver disorder
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
nonalcoholic fatty liver disease
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Investigations
|
|
|
|
|
blood creatine phosphokinase increased
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
2 / 592 (0.34%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
blood glucose increased
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
blood pressure increased
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
cardiac murmur
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
electrocardiogram t wave inversion
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
electrocardiogram change
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
glomerular filtration rate decreased
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
haemoglobin decreased
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
influenza a virus test positive
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
mycobacterium tuberculosis complex test positive
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
transaminases increased
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
|
|
accident
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
ankle fracture
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
brain herniation
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
burns second degree
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
carbon monoxide poisoning
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
cervical vertebral fracture
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
colon injury
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
compression fracture
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
contusion
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
crush injury
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
dislocation of vertebra
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
epiphyseal injury
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
face injury
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
fall
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
2 / 297 (0.67%) |
13 / 2579 (0.50%) |
1 / 592 (0.17%) |
3 / 594 (0.51%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 14 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
femoral neck fracture
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
1 / 2579 (0.04%) |
2 / 592 (0.34%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
femur fracture
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
7 / 2579 (0.27%) |
3 / 592 (0.51%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 8 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
fibula fracture
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
foot fracture
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
3 / 2579 (0.12%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
hand fracture
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
head injury
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
hip fracture
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
5 / 2579 (0.19%) |
2 / 592 (0.34%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
humerus fracture
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
3 / 2579 (0.12%) |
1 / 592 (0.17%) |
3 / 594 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
injury
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
joint dislocation
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
3 / 2579 (0.12%) |
2 / 592 (0.34%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
joint injury
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
keratorhexis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
ligament rupture
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
lower limb fracture
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
3 / 2579 (0.12%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
lumbar vertebral fracture
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
meniscus injury
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
7 / 2579 (0.27%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 7 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
open globe injury
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
open fracture
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
overdose
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
patella fracture
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
pelvic fracture
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
periprosthetic fracture
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
post procedural complication
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
post procedural haematoma
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
post procedural haemorrhage
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
radius fracture
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
rib fracture
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
road traffic accident
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
3 / 2579 (0.12%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
scapula fracture
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
seroma
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
skin wound
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
skull fracture
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
spinal compression fracture
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
6 / 2579 (0.23%) |
1 / 592 (0.17%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
suture rupture
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
synovial rupture
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
tendon injury
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
tendon rupture
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
2 / 592 (0.34%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
thoracic vertebral fracture
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
tibia fracture
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
3 / 2579 (0.12%) |
1 / 592 (0.17%) |
4 / 594 (0.67%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 1 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
toxicity to various agents
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
traumatic arthritis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
upper limb fracture
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
1 / 592 (0.17%) |
2 / 594 (0.34%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
wound
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
wound dehiscence
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
wrist fracture
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
|
|
congenital central nervous system anomaly
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
hydrocele
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [35]
|
0 / 66 (0.00%) |
1 / 548 (0.18%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
hypertrophic cardiomyopathy
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
|
|
acute coronary syndrome
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
acute left ventricular failure
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
acute myocardial infarction
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
4 / 297 (1.35%) |
7 / 2579 (0.27%) |
1 / 592 (0.17%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
2 / 5 |
1 / 7 |
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 1 |
angina pectoris
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
3 / 2579 (0.12%) |
1 / 592 (0.17%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 3 |
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
angina unstable
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
5 / 2579 (0.19%) |
1 / 592 (0.17%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
1 / 1 |
2 / 5 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
aortic valve disease
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
aortic valve incompetence
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
aortic valve stenosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
arteriosclerosis coronary artery
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
atrial fibrillation
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
4 / 297 (1.35%) |
11 / 2579 (0.43%) |
1 / 592 (0.17%) |
3 / 594 (0.51%) |
occurrences causally related to treatment / all
|
0 / 5 |
4 / 13 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
atrial tachycardia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
atrioventricular block complete
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
bradycardia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
bundle branch block left
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
cardiac arrest
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
4 / 2579 (0.16%) |
2 / 592 (0.34%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
cardiac failure
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
1 / 2579 (0.04%) |
1 / 592 (0.17%) |
2 / 594 (0.34%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
1 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 2 |
cardiac failure acute
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
cardiac failure chronic
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
cardiac failure congestive
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
3 / 297 (1.01%) |
4 / 2579 (0.16%) |
1 / 592 (0.17%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 4 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
cardio-respiratory arrest
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
chronic left ventricular failure
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
coronary artery disease
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
3 / 2579 (0.12%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
coronary artery occlusion
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
coronary artery stenosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
mitral valve disease
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
mitral valve incompetence
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
2 / 594 (0.34%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
myocardial infarction
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
4 / 2579 (0.16%) |
2 / 592 (0.34%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
3 / 6 |
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
myocardial ischaemia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
2 / 592 (0.34%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
palpitations
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
pericarditis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
right ventricular failure
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
sinus node dysfunction
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
sinus tachycardia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
stress cardiomyopathy
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
supraventricular tachycardia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
ventricular arrhythmia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
ventricular fibrillation
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
ventricular tachycardia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
|
|
amyotrophic lateral sclerosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
autonomic neuropathy
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
basal ganglia haemorrhage
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
central nervous system vasculitis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
cerebellar infarction
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
cerebellar stroke
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
cerebral artery stenosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
cerebral artery thrombosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
cerebral haemorrhage
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
cerebral infarction
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
1 / 592 (0.17%) |
2 / 594 (0.34%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
cerebral microhaemorrhage
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
cerebral thrombosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
cerebral venous thrombosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
cerebrospinal fistula
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
cerebrovascular accident
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
cerebrospinal fluid leakage
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
cerebrovascular disorder
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
cervical cord compression
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
cervical radiculopathy
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
dementia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
depressed level of consciousness
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
dizziness
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
embolic stroke
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
epilepsy
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
haemorrhage intracranial
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
haemorrhagic stroke
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
5 / 2579 (0.19%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
headache
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
1 / 2579 (0.04%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
hemiparesis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
intercostal neuralgia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
intracranial aneurysm
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
ischaemic cerebral infarction
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
ischaemic stroke
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
5 / 297 (1.68%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
leukoencephalopathy
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
loss of consciousness
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
metabolic encephalopathy
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
migraine
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
myelopathy
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 3 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
neuralgia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
neuropathy peripheral
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
peripheral sensorimotor neuropathy
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
post herpetic neuralgia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
presyncope
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
radiculopathy
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
sciatica
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
3 / 2579 (0.12%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
seizure
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
sensory disturbance
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
subarachnoid haemorrhage
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
syncope
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
9 / 2579 (0.35%) |
1 / 592 (0.17%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 10 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
thalamus haemorrhage
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
transient ischaemic attack
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
4 / 2579 (0.16%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
|
|
anaemia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
2 / 297 (0.67%) |
3 / 2579 (0.12%) |
2 / 592 (0.34%) |
3 / 594 (0.51%) |
occurrences causally related to treatment / all
|
1 / 2 |
3 / 4 |
0 / 2 |
2 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
coagulopathy
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
febrile neutropenia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
leukocytosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
lymphopenia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
normochromic normocytic anaemia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
normocytic anaemia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
pancytopenia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
3 / 2579 (0.12%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
thrombocytopenia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
thrombocytosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
|
|
conductive deafness
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deafness unilateral
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
meniere's disease
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
sudden hearing loss
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
vertigo
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
vertigo positional
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
|
|
cataract
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
6 / 2579 (0.23%) |
3 / 592 (0.51%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 13 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
cataract subcapsular
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
corneal perforation
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
dry age-related macular degeneration
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
glaucoma
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
1 / 592 (0.17%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
keratitis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
macular rupture
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
ocular hypertension
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
retinal detachment
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
rhegmatogenous retinal detachment
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
|
|
abdominal pain
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
abdominal pain upper
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
abdominal wall haematoma
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
anal fistula
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
colitis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
3 / 2579 (0.12%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 3 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
colitis ischaemic
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
colitis ulcerative
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
dental cyst
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
diarrhoea
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
diverticular perforation
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
diverticulum
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
diverticulum intestinal
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
duodenal ulcer haemorrhage
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
duodenitis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
dysphagia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
enterocolitis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
2 / 592 (0.34%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
gastric ulcer
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
3 / 2579 (0.12%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
gastric ulcer haemorrhage
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
gastric ulcer perforation
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
gastritis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
gastritis erosive
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
gastrointestinal haemorrhage
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
3 / 2579 (0.12%) |
1 / 592 (0.17%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 3 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
gastrooesophageal reflux disease
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
haemorrhoids
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
hiatus hernia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
ileus
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
inguinal hernia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
intestinal obstruction
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
intestinal perforation
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
irritable bowel syndrome
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
obstructive pancreatitis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
oesophageal stenosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
pancreatitis acute
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
6 / 2579 (0.23%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 7 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
parotid gland enlargement
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
rectal haemorrhage
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
rectal polyp
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
reflux gastritis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
small intestinal obstruction
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
umbilical hernia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
2 / 594 (0.34%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
upper gastrointestinal haemorrhage
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
2 / 2579 (0.08%) |
1 / 592 (0.17%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
volvulus
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
vomiting
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
|
|
actinic keratosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
angioedema
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
diabetic ulcer
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
eczema asteatotic
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
granuloma skin
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
skin necrosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
skin ulcer
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
|
|
acute kidney injury
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
4 / 2579 (0.16%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
bladder prolapse
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
calculus bladder
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
calculus urinary
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
chronic kidney disease
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
glomerulonephritis membranous
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
hydronephrosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
3 / 2579 (0.12%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
iga nephropathy
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
nephrolithiasis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
2 / 297 (0.67%) |
5 / 2579 (0.19%) |
3 / 592 (0.51%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
oliguria
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
proteinuria
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
renal colic
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
renal cyst
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
renal injury
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
renal pain
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
renal vein thrombosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
stress urinary incontinence
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
tubulointerstitial nephritis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
ureterolithiasis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
6 / 2579 (0.23%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 7 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
urinary tract inflammation
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
|
|
adrenal suppression
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
goitre
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
hyperparathyroidism
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
|
|
acquired claw toe
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
arthralgia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
2 / 297 (0.67%) |
2 / 2579 (0.08%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
arthritis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
3 / 2579 (0.12%) |
2 / 592 (0.34%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
back pain
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
5 / 2579 (0.19%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 8 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
cervical spinal stenosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
2 / 592 (0.34%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
chondrocalcinosis pyrophosphate
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
diastasis recti abdominis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
foot deformity
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
4 / 2579 (0.16%) |
3 / 592 (0.51%) |
6 / 594 (1.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
fracture delayed union
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
haematoma muscle
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
intervertebral disc compression
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
intervertebral disc degeneration
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
intervertebral disc disorder
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
intervertebral disc protrusion
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
7 / 2579 (0.27%) |
5 / 592 (0.84%) |
2 / 594 (0.34%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 7 |
0 / 7 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
joint destruction
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
lumbar spinal stenosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
4 / 2579 (0.16%) |
1 / 592 (0.17%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
mixed connective tissue disease
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
muscular weakness
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
musculoskeletal chest pain
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
osteoarthritis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
8 / 297 (2.69%) |
42 / 2579 (1.63%) |
6 / 592 (1.01%) |
5 / 594 (0.84%) |
occurrences causally related to treatment / all
|
0 / 13 |
4 / 56 |
0 / 9 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
osteochondrosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
osteonecrosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
2 / 2579 (0.08%) |
2 / 592 (0.34%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
osteoporosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
osteoporotic fracture
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
pain in extremity
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
rhabdomyolysis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
rheumatoid arthritis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
4 / 297 (1.35%) |
16 / 2579 (0.62%) |
0 / 592 (0.00%) |
3 / 594 (0.51%) |
occurrences causally related to treatment / all
|
0 / 6 |
1 / 18 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
rheumatoid nodule
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
rotator cuff syndrome
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
scoliosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
spinal instability
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
spinal osteoarthritis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
spinal pain
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
2 / 2579 (0.08%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
spinal stenosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
3 / 2579 (0.12%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 6 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
spondyloarthropathy
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
spondylolisthesis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
synovial cyst
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
synovitis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
tendonitis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
tenosynovitis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
|
|
abdominal infection
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
abdominal wall abscess
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
abscess intestinal
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
abscess limb
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
1 / 592 (0.17%) |
3 / 594 (0.51%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
1 / 1 |
2 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
anal abscess
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
appendicitis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
2 / 297 (0.67%) |
3 / 2579 (0.12%) |
0 / 592 (0.00%) |
4 / 594 (0.67%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 3 |
0 / 0 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
appendicitis perforated
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
arthritis bacterial
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
3 / 2579 (0.12%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
1 / 1 |
2 / 3 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
arthritis infective
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
atypical pneumonia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
3 / 2579 (0.12%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
bacteraemia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
bacterial infection
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
bone tuberculosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
3 / 2579 (0.12%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
breast abscess
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
bronchitis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
5 / 2579 (0.19%) |
2 / 592 (0.34%) |
5 / 594 (0.84%) |
occurrences causally related to treatment / all
|
0 / 1 |
3 / 6 |
3 / 3 |
6 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
bronchitis viral
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
bursitis infective
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
bursitis infective staphylococcal
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
covid-19
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
2 / 592 (0.34%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
covid-19 pneumonia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
cellulitis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
3 / 297 (1.01%) |
12 / 2579 (0.47%) |
0 / 592 (0.00%) |
4 / 594 (0.67%) |
occurrences causally related to treatment / all
|
2 / 3 |
7 / 14 |
0 / 0 |
4 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
cholecystitis infective
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
chronic sinusitis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
2 / 594 (0.34%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
chronic tonsillitis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
coronavirus infection
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
cystitis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
2 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
cytomegalovirus hepatitis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
cytomegalovirus infection
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
dengue fever
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
device related infection
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
4 / 2579 (0.16%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 5 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
device related sepsis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
disseminated tuberculosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
3 / 2579 (0.12%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
3 / 3 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
diverticulitis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
3 / 297 (1.01%) |
4 / 2579 (0.16%) |
3 / 592 (0.51%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
2 / 4 |
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
empyema
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
encephalitis viral
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
endocarditis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
endocarditis bacterial
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
enteritis infectious
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
enterobacter pneumonia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
enterocolitis infectious
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
erysipelas
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
escherichia sepsis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
extrapulmonary tuberculosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
fascial infection
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
gangrene
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
gastroenteritis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
7 / 2579 (0.27%) |
1 / 592 (0.17%) |
2 / 594 (0.34%) |
occurrences causally related to treatment / all
|
1 / 1 |
2 / 7 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
gastroenteritis norovirus
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
gastroenteritis salmonella
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
gastroenteritis viral
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
groin abscess
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
h1n1 influenza
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
haematoma infection
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
helicobacter gastritis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
hepatitis e
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
herpes zoster
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
5 / 297 (1.68%) |
15 / 2579 (0.58%) |
2 / 592 (0.34%) |
5 / 594 (0.84%) |
occurrences causally related to treatment / all
|
4 / 5 |
20 / 20 |
3 / 3 |
4 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
herpes zoster infection neurological
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
herpes zoster meningitis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
histoplasmosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
implant site infection
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
incision site cellulitis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
infected dermal cyst
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
infected skin ulcer
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
infection
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
infectious pleural effusion
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
3 / 3 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
infective aneurysm
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
influenza
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
4 / 2579 (0.16%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 4 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
intervertebral discitis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
klebsiella bacteraemia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
localised infection
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
lower respiratory tract infection
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
lung abscess
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
lymph node tuberculosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
meningoencephalitis bacterial
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
necrotising fasciitis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
ophthalmic herpes zoster
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
oral fungal infection
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
orchitis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [36]
|
0 / 66 (0.00%) |
1 / 548 (0.18%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
osteomyelitis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
otitis media
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
3 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
paracoccidioides infection
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
paronychia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
pelvic abscess
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
perirectal abscess
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
peritonitis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
plasmodium falciparum infection
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
plasmodium vivax infection
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
pneumonia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
15 / 297 (5.05%) |
34 / 2579 (1.32%) |
10 / 592 (1.69%) |
12 / 594 (2.02%) |
occurrences causally related to treatment / all
|
11 / 17 |
20 / 36 |
11 / 14 |
8 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 1 |
0 / 2 |
pneumonia bacterial
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
pneumonia cryptococcal
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
pneumonia influenzal
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
2 / 297 (0.67%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
3 / 3 |
0 / 0 |
0 / 1 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
pneumonia legionella
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
pneumonia viral
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
post procedural infection
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
postoperative abscess
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
postoperative wound infection
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
pseudomonal bacteraemia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
psoas abscess
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
pulmonary tuberculosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
pyelitis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
pyelonephritis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
3 / 2579 (0.12%) |
4 / 592 (0.68%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
3 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
pyelonephritis acute
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
2 / 297 (0.67%) |
2 / 2579 (0.08%) |
1 / 592 (0.17%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 5 |
2 / 2 |
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
respiratory syncytial virus infection
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
respiratory tract infection
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
2 / 297 (0.67%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
salpingitis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [37]
|
0 / 231 (0.00%) |
1 / 2031 (0.05%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
sepsis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
3 / 297 (1.01%) |
10 / 2579 (0.39%) |
1 / 592 (0.17%) |
2 / 594 (0.34%) |
occurrences causally related to treatment / all
|
2 / 4 |
5 / 10 |
1 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
2 / 3 |
0 / 0 |
0 / 0 |
septic shock
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
4 / 2579 (0.16%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 4 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
2 / 3 |
0 / 0 |
0 / 0 |
sinusitis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
sinusitis bacterial
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
skin infection
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
staphylococcal bacteraemia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
staphylococcal sepsis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
subcutaneous abscess
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
systemic infection
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
testicular abscess
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [38]
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 152 (0.66%) |
0 / 146 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
thrombophlebitis septic
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
tooth abscess
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
tuberculosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
2 / 594 (0.34%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
upper respiratory tract infection
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
4 / 2579 (0.16%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 4 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
urinary tract infection
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
4 / 297 (1.35%) |
12 / 2579 (0.47%) |
0 / 592 (0.00%) |
3 / 594 (0.51%) |
occurrences causally related to treatment / all
|
3 / 7 |
7 / 12 |
0 / 0 |
2 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
urinary tract infection bacterial
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
2 / 297 (0.67%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
urinary tract infection enterococcal
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
urosepsis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
4 / 2579 (0.16%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 6 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
1 / 1 |
varicella
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
varicella zoster virus infection
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
viral infection
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
vulvitis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed [39]
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 440 (0.23%) |
0 / 448 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
wound abscess
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
1 / 297 (0.34%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
wound infection
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
wound sepsis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
4 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
|
|
dehydration
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
4 / 2579 (0.16%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
diabetes mellitus
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
1 / 592 (0.17%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
diabetic ketoacidosis
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
2 / 2579 (0.08%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
diabetic metabolic decompensation
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
electrolyte imbalance
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
hyperglycaemia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
hyperkalaemia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
0 / 2579 (0.00%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
hypokalaemia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
3 / 2579 (0.12%) |
1 / 592 (0.17%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
hyponatraemia
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
1 / 594 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
obesity
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
2 / 297 (0.67%) |
0 / 2579 (0.00%) |
2 / 592 (0.34%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
type 2 diabetes mellitus
|
|
|
|
|
alternative dictionary used: MedDRA
23.1
|
|
|
|
|
subjects affected / exposed
|
0 / 297 (0.00%) |
1 / 2579 (0.04%) |
0 / 592 (0.00%) |
0 / 594 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |