Serious adverse events
|
Placebo |
Ticagrelor 90mg bd |
Ticagrelor 60mg bd |
Total subjects affected by serious adverse events
|
|
|
|
subjects affected / exposed
|
1757 / 6996 (25.11%) |
1918 / 6988 (27.45%) |
1853 / 6958 (26.63%) |
number of deaths (all causes)
|
329 |
333 |
290 |
number of deaths resulting from adverse events
|
11 |
5 |
14 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
Acinic cell carcinoma of salivary gland
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute myeloid leukaemia
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
3 / 6996 (0.04%) |
2 / 6988 (0.03%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Adenocarcinoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Adenocarcinoma gastric
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
4 / 6996 (0.06%) |
3 / 6988 (0.04%) |
5 / 6958 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Adenocarcinoma of colon
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
7 / 6996 (0.10%) |
7 / 6988 (0.10%) |
7 / 6958 (0.10%) |
occurrences causally related to treatment / all
|
0 / 7 |
1 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Adenolymphoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Adrenal adenoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ameloblastoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anal cancer
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anal cancer metastatic
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Anaplastic large cell lymphoma T- and null-cell types
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Anogenital warts
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Astrocytoma malignant
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atypical fibroxanthoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
B-cell lymphoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
3 / 6958 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Basal cell carcinoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
6 / 6996 (0.09%) |
9 / 6988 (0.13%) |
4 / 6958 (0.06%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 12 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Benign neoplasm of bladder
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
1 / 6988 (0.01%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Benign neoplasm of thyroid gland
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
2 / 6988 (0.03%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Benign neoplasm of ureter
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Benign ovarian tumour
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Benign pancreatic neoplasm
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Benign renal neoplasm
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Benign salivary gland neoplasm
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Benign soft tissue neoplasm
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bile duct adenocarcinoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Bile duct cancer
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Biliary neoplasm
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder cancer
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
11 / 6996 (0.16%) |
5 / 6988 (0.07%) |
15 / 6958 (0.22%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 5 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder cancer recurrent
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
3 / 6958 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder neoplasm
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
3 / 6996 (0.04%) |
4 / 6988 (0.06%) |
7 / 6958 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder papilloma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
5 / 6996 (0.07%) |
3 / 6988 (0.04%) |
4 / 6958 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma metastatic
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma recurrent
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
2 / 6996 (0.03%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bone cancer
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Bone cancer metastatic
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Bone sarcoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bowen's disease
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Brain cancer metastatic
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Brain neoplasm
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
Brain neoplasm malignant
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Breast cancer female
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
7 / 6996 (0.10%) |
7 / 6988 (0.10%) |
4 / 6958 (0.06%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Breast cancer male
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Breast cancer metastatic
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
4 / 6996 (0.06%) |
4 / 6988 (0.06%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Breast cancer recurrent
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Brenner tumour
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchial carcinoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
2 / 6996 (0.03%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchioloalveolar carcinoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cervix cancer metastatic
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cervix carcinoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cervix carcinoma stage 0
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholangiocarcinoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Cholesteatoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Choroid melanoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronic lymphocytic leukaemia
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
2 / 6996 (0.03%) |
2 / 6988 (0.03%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronic myeloid leukaemia
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Clear cell renal cell carcinoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colon adenoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
6 / 6996 (0.09%) |
7 / 6988 (0.10%) |
3 / 6958 (0.04%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colon cancer
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
7 / 6996 (0.10%) |
14 / 6988 (0.20%) |
14 / 6958 (0.20%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 14 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Colon cancer metastatic
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
8 / 6996 (0.11%) |
7 / 6988 (0.10%) |
5 / 6958 (0.07%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 9 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 5 |
0 / 5 |
Colon neoplasm
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
2 / 6988 (0.03%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colorectal adenocarcinoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colorectal cancer
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diffuse large B-cell lymphoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
2 / 6996 (0.03%) |
2 / 6988 (0.03%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Endometrial adenocarcinoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endometrial cancer
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
2 / 6996 (0.03%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endometrial cancer stage I
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Epithelioid mesothelioma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Essential thrombocythaemia
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fallopian tube cancer
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fibroma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Follicle centre lymphoma, follicular grade I, II, III stage IV
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gallbladder adenocarcinoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gallbladder cancer
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
2 / 6988 (0.03%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Gallbladder cancer metastatic
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Gastric adenoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric cancer
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
8 / 6996 (0.11%) |
8 / 6988 (0.11%) |
6 / 6958 (0.09%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 10 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
Gastrointestinal cancer metastatic
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal carcinoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
2 / 6996 (0.03%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal stromal cancer
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal stromal tumour
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal tract adenoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
2 / 6988 (0.03%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrooesophageal cancer
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Glioblastoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
3 / 6996 (0.04%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
Glioblastoma multiforme
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
3 / 6958 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
Haemangioma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic cancer
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
1 / 6988 (0.01%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Hepatic cancer metastatic
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
Hepatic neoplasm
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
2 / 6988 (0.03%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatocellular carcinoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
2 / 6996 (0.03%) |
0 / 6988 (0.00%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Hodgkin's disease
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
1 / 6988 (0.01%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypergammaglobulinaemia benign monoclonal
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Inflammatory pseudotumour
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal adenocarcinoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
2 / 6988 (0.03%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Invasive ductal breast carcinoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
2 / 6988 (0.03%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Large intestine benign neoplasm
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Laryngeal cancer
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
2 / 6988 (0.03%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Laryngeal neoplasm
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Laryngeal squamous cell carcinoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Leiomyoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Leiomyosarcoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lentigo maligna
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
2 / 6996 (0.03%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Leukaemia
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lip and/or oral cavity cancer
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
Lip neoplasm malignant stage unspecified
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lipoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
5 / 6996 (0.07%) |
4 / 6988 (0.06%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Lung adenocarcinoma metastatic
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
3 / 6988 (0.04%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
Lung cancer metastatic
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
10 / 6996 (0.14%) |
14 / 6988 (0.20%) |
11 / 6958 (0.16%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 14 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 8 |
0 / 9 |
0 / 3 |
Lung carcinoma cell type unspecified recurrent
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung carcinoma cell type unspecified stage I
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung carcinoma cell type unspecified stage IV
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
2 / 6996 (0.03%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Lung neoplasm
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
2 / 6996 (0.03%) |
1 / 6988 (0.01%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung neoplasm malignant
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
10 / 6996 (0.14%) |
17 / 6988 (0.24%) |
10 / 6958 (0.14%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 17 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 9 |
0 / 5 |
Lymphoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
4 / 6988 (0.06%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
Lymphoma cutis
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lymphoplasmacytoid lymphoma/immunocytoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Malignant anorectal neoplasm
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Malignant ascites
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Malignant fibrous histiocytoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Malignant melanoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
10 / 6996 (0.14%) |
5 / 6988 (0.07%) |
7 / 6958 (0.10%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 5 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
Malignant neoplasm of ampulla of Vater
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Malignant neoplasm of unknown primary site
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
3 / 6996 (0.04%) |
2 / 6988 (0.03%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
Malignant peritoneal neoplasm
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Malignant pleural effusion
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mediastinum neoplasm
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Melanocytic naevus
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Meningioma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
2 / 6996 (0.03%) |
0 / 6988 (0.00%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Meningioma benign
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to bone
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to central nervous system
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to liver
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to lung
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to lymph nodes
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Metastases to pancreas
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Metastases to peritoneum
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastatic bronchial carcinoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
3 / 6996 (0.04%) |
1 / 6988 (0.01%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
Metastatic carcinoma of the bladder
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
Metastatic gastric cancer
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
6 / 6996 (0.09%) |
2 / 6988 (0.03%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 1 |
Metastatic malignant melanoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
4 / 6988 (0.06%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
Metastatic neoplasm
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Metastatic pain
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastatic salivary gland cancer
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastatic squamous cell carcinoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Monoclonal gammopathy
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myelofibrosis
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myeloproliferative disorder
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nasal neoplasm benign
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neoplasm
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Neoplasm malignant
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
Neoplasm prostate
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neoplasm skin
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neuroendocrine carcinoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
Neuroendocrine carcinoma metastatic
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
2 / 6988 (0.03%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neuroendocrine tumour
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Non-Hodgkin's lymphoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
2 / 6996 (0.03%) |
2 / 6988 (0.03%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Non-Hodgkin's lymphoma recurrent
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Non-Hodgkin's lymphoma stage I
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Non-Hodgkin's lymphoma stage II
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Non-Hodgkin's lymphoma unspecified histology aggressive
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Non-small cell lung cancer
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
3 / 6988 (0.04%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Non-small cell lung cancer metastatic
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Oesophageal adenocarcinoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal adenocarcinoma metastatic
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Oesophageal cancer metastatic
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
1 / 6988 (0.01%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Oesophageal carcinoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
2 / 6996 (0.03%) |
5 / 6988 (0.07%) |
4 / 6958 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 0 |
Oncocytoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oral cavity cancer metastatic
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oropharyngeal cancer recurrent
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ovarian cancer
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Ovarian cancer metastatic
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Ovarian cancer stage III
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ovarian germ cell teratoma benign
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancoast's tumour
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Pancreatic carcinoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
3 / 6996 (0.04%) |
6 / 6988 (0.09%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 1 |
Pancreatic carcinoma metastatic
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
6 / 6996 (0.09%) |
5 / 6988 (0.07%) |
4 / 6958 (0.06%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 4 |
Pancreatic neoplasm
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Paranasal sinus neoplasm
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Parathyroid tumour benign
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
2 / 6996 (0.03%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic neoplasm
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Penile squamous cell carcinoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Penis carcinoma metastatic
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peritoneal neoplasm
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pharyngeal cancer
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pharyngeal cancer metastatic
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pituitary tumour benign
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
2 / 6988 (0.03%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Plasma cell myeloma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
2 / 6996 (0.03%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pleomorphic adenoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pleural mesothelioma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Pleural mesothelioma malignant
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Polycythaemia vera
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostate cancer
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
37 / 6996 (0.53%) |
38 / 6988 (0.54%) |
29 / 6958 (0.42%) |
occurrences causally related to treatment / all
|
0 / 37 |
0 / 38 |
0 / 29 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
Prostate cancer metastatic
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
2 / 6996 (0.03%) |
8 / 6988 (0.11%) |
5 / 6958 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 3 |
Prostate cancer recurrent
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostate cancer stage II
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatic adenoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
2 / 6996 (0.03%) |
2 / 6988 (0.03%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectal adenocarcinoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
3 / 6988 (0.04%) |
3 / 6958 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectal adenoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectal cancer
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
3 / 6988 (0.04%) |
5 / 6958 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Rectal cancer metastatic
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
2 / 6988 (0.03%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Rectosigmoid cancer
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal cancer
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
4 / 6988 (0.06%) |
5 / 6958 (0.07%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal cancer metastatic
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
Renal cell carcinoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
4 / 6996 (0.06%) |
5 / 6988 (0.07%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal cell carcinoma recurrent
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal neoplasm
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
3 / 6988 (0.04%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal oncocytoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Salivary gland adenoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Salivary gland cancer
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
1 / 6988 (0.01%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Salivary gland cancer recurrent
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Salivary gland neoplasm
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
2 / 6988 (0.03%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sarcoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sarcomatoid mesothelioma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin cancer
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
2 / 6996 (0.03%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Small cell lung cancer
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
2 / 6996 (0.03%) |
4 / 6988 (0.06%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Small cell lung cancer metastatic
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
2 / 6988 (0.03%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
Small intestine carcinoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal cord neoplasm
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Splenic marginal zone lymphoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
1 / 6988 (0.01%) |
4 / 6958 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
Squamous cell carcinoma of lung
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
4 / 6988 (0.06%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Squamous cell carcinoma of pharynx
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma of skin
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
2 / 6988 (0.03%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thyroid adenoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thyroid cancer
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thyroid cancer metastatic
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Thyroid neoplasm
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tongue cancer metastatic
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tongue neoplasm malignant stage unspecified
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tonsil cancer
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tonsillar neoplasm
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Transitional cell carcinoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
3 / 6996 (0.04%) |
6 / 6988 (0.09%) |
6 / 6958 (0.09%) |
occurrences causally related to treatment / all
|
0 / 4 |
1 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Transitional cell carcinoma metastatic
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Tumour associated fever
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tumour haemorrhage
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
2 / 6996 (0.03%) |
0 / 6988 (0.00%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tumour pain
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Undifferentiated nasopharyngeal carcinoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ureteric cancer
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urethral cancer
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract neoplasm
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uterine leiomyoma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
|
Accelerated hypertension
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
2 / 6988 (0.03%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Angiodysplasia
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic aneurysm
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
13 / 6996 (0.19%) |
19 / 6988 (0.27%) |
19 / 6958 (0.27%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 20 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic aneurysm rupture
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
4 / 6988 (0.06%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
Aortic dissection
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Aortic dissection rupture
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Aortic rupture
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Aortic stenosis
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
8 / 6996 (0.11%) |
2 / 6988 (0.03%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Aortic thrombosis
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
2 / 6996 (0.03%) |
1 / 6988 (0.01%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Aorto-duodenal fistula
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arterial rupture
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arteriosclerosis
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
2 / 6996 (0.03%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Arteriovenous fistula
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Circulatory collapse
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Deep vein thrombosis
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
10 / 6996 (0.14%) |
10 / 6988 (0.14%) |
4 / 6958 (0.06%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 11 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic vascular disorder
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
3 / 6996 (0.04%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Essential hypertension
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Extremity necrosis
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Femoral artery aneurysm
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Femoral artery embolism
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Femoral artery occlusion
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hot flush
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertension
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
18 / 6996 (0.26%) |
8 / 6988 (0.11%) |
15 / 6958 (0.22%) |
occurrences causally related to treatment / all
|
1 / 18 |
0 / 8 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive crisis
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
12 / 6996 (0.17%) |
10 / 6988 (0.14%) |
8 / 6958 (0.11%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 11 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive emergency
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
4 / 6958 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypotension
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
10 / 6996 (0.14%) |
10 / 6988 (0.14%) |
9 / 6958 (0.13%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 10 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypothenar hammer syndrome
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypovolaemic shock
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Iliac artery occlusion
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intermittent claudication
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
5 / 6996 (0.07%) |
4 / 6988 (0.06%) |
4 / 6958 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Leriche syndrome
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lymphoedema
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Malignant hypertension
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Orthostatic hypotension
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
4 / 6996 (0.06%) |
5 / 6988 (0.07%) |
4 / 6958 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Penetrating atherosclerotic ulcer
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral arterial occlusive disease
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
15 / 6996 (0.21%) |
17 / 6988 (0.24%) |
10 / 6958 (0.14%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 17 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery aneurysm
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
3 / 6996 (0.04%) |
1 / 6988 (0.01%) |
4 / 6958 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery stenosis
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
17 / 6996 (0.24%) |
5 / 6988 (0.07%) |
5 / 6958 (0.07%) |
occurrences causally related to treatment / all
|
0 / 22 |
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery thrombosis
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
5 / 6996 (0.07%) |
4 / 6988 (0.06%) |
3 / 6958 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral circulatory failure
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Peripheral embolism
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
1 / 6988 (0.01%) |
3 / 6958 (0.04%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral ischaemia
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
9 / 6996 (0.13%) |
5 / 6988 (0.07%) |
3 / 6958 (0.04%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral vascular disorder
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
8 / 6996 (0.11%) |
4 / 6988 (0.06%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Poor peripheral circulation
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Shock
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Shock haemorrhagic
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Steal syndrome
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subclavian artery occlusion
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subclavian artery stenosis
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Superior vena cava syndrome
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Temporal arteritis
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thrombophlebitis
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
2 / 6988 (0.03%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thrombosis
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
2 / 6996 (0.03%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Varicose vein
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
2 / 6988 (0.03%) |
5 / 6958 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vasculitis
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Vena cava thrombosis
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Venous insufficiency
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Venous thrombosis
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
|
Asthenia
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
2 / 6988 (0.03%) |
7 / 6958 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac death
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
1 / 6988 (0.01%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
Catheter site haemorrhage
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
2 / 6996 (0.03%) |
3 / 6988 (0.04%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
2 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chest discomfort
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
2 / 6996 (0.03%) |
2 / 6988 (0.03%) |
4 / 6958 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chest pain
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
4 / 6996 (0.06%) |
6 / 6988 (0.09%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Death
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
42 / 6996 (0.60%) |
42 / 6988 (0.60%) |
34 / 6958 (0.49%) |
occurrences causally related to treatment / all
|
0 / 42 |
2 / 42 |
3 / 34 |
deaths causally related to treatment / all
|
0 / 42 |
2 / 42 |
3 / 34 |
Device battery issue
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device breakage
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device defective
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device dislocation
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
3 / 6988 (0.04%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device lead damage
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
2 / 6988 (0.03%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device lead issue
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device malfunction
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
2 / 6996 (0.03%) |
3 / 6988 (0.04%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Device material issue
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device occlusion
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Drowning
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Drug withdrawal syndrome
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Euthanasia
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Fatigue
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gait disturbance
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
General physical health deterioration
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Hernia obstructive
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypothermia
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Impaired healing
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
2 / 6996 (0.03%) |
3 / 6988 (0.04%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Implant site pain
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Injection site bruising
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Malaise
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
1 / 6988 (0.01%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Medical device complication
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Multi-organ failure
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Non-cardiac chest pain
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
109 / 6996 (1.56%) |
115 / 6988 (1.65%) |
113 / 6958 (1.62%) |
occurrences causally related to treatment / all
|
0 / 118 |
3 / 122 |
1 / 124 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pain
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
3 / 6996 (0.04%) |
3 / 6988 (0.04%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Stent-graft endoleak
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sudden cardiac death
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
33 / 6996 (0.47%) |
27 / 6988 (0.39%) |
27 / 6958 (0.39%) |
occurrences causally related to treatment / all
|
0 / 33 |
0 / 27 |
0 / 27 |
deaths causally related to treatment / all
|
0 / 33 |
0 / 27 |
0 / 27 |
Sudden death
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
9 / 6996 (0.13%) |
6 / 6988 (0.09%) |
11 / 6958 (0.16%) |
occurrences causally related to treatment / all
|
1 / 9 |
0 / 6 |
0 / 11 |
deaths causally related to treatment / all
|
1 / 9 |
0 / 6 |
0 / 11 |
Systemic inflammatory response syndrome
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vessel puncture site haemorrhage
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
|
Allergy to arthropod sting
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anaphylactic reaction
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
2 / 6996 (0.03%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anaphylactic shock
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
2 / 6988 (0.03%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anti-neutrophil cytoplasmic antibody positive vasculitis
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Contrast media allergy
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Drug hypersensitivity
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypersensitivity
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Reaction to food additive
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sarcoidosis
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
|
Acquired hydrocele
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
4 / 6996 (0.06%) |
2 / 6988 (0.03%) |
4 / 6958 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acquired phimosis
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
3 / 6958 (0.04%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Benign prostatic hyperplasia
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
26 / 6996 (0.37%) |
20 / 6988 (0.29%) |
25 / 6958 (0.36%) |
occurrences causally related to treatment / all
|
0 / 26 |
0 / 20 |
2 / 26 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Breast fibrosis
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Calculus prostatic
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cervical cyst
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cervical dysplasia
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cystocele
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endometrial hyperplasia
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
2 / 6988 (0.03%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gynaecomastia
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Menorrhagia
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metrorrhagia
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
1 / 6988 (0.01%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ovarian cyst
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ovarian necrosis
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Postmenopausal haemorrhage
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatic mass
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatism
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatitis
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
7 / 6996 (0.10%) |
5 / 6988 (0.07%) |
5 / 6958 (0.07%) |
occurrences causally related to treatment / all
|
0 / 7 |
1 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatomegaly
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
2 / 6988 (0.03%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uterine cyst
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uterine haemorrhage
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
2 / 6996 (0.03%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uterine polyp
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uterine prolapse
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uterovaginal prolapse
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vaginal prolapse
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Varicocele
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
Acute pulmonary oedema
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
5 / 6996 (0.07%) |
2 / 6988 (0.03%) |
3 / 6958 (0.04%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Acute respiratory distress syndrome
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
1 / 6988 (0.01%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
Acute respiratory failure
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
7 / 6996 (0.10%) |
6 / 6988 (0.09%) |
2 / 6958 (0.03%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 7 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 0 |
Aspiration
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
1 / 6988 (0.01%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Asthma
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
4 / 6996 (0.06%) |
9 / 6988 (0.13%) |
6 / 6958 (0.09%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 12 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Atelectasis
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchial haemorrhage
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchial hyperreactivity
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
2 / 6996 (0.03%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchial obstruction
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
0 / 6996 (0.00%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchiectasis
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
1 / 6958 (0.01%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchitis chronic
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
1 / 6996 (0.01%) |
0 / 6988 (0.00%) |
0 / 6958 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchospasm
|
|
|
|
alternative dictionary used: MedDRA
17
|
|
|
|
subjects affected / exposed
|
2 / 6996 (0.03%) |
0 / 6988 (0.00%) |
0 / 6958 (0 |