Serious adverse events
|
V212-STM |
V212-HM |
Placebo-STM |
Placebo-HM |
Total subjects affected by serious adverse events
|
|
|
|
|
subjects affected / exposed
|
794 / 1322 (60.06%) |
500 / 1274 (39.25%) |
808 / 1346 (60.03%) |
507 / 1274 (39.80%) |
number of deaths (all causes)
|
472 |
159 |
488 |
146 |
number of deaths resulting from adverse events
|
0 |
1 |
0 |
0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
|
Acute leukaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
2 / 1274 (0.16%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Acute lymphocytic leukaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
4 / 1274 (0.31%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 1 |
Acute lymphocytic leukaemia recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
2 / 1274 (0.16%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Acute monocytic leukaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute myeloid leukaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
5 / 1274 (0.39%) |
1 / 1346 (0.07%) |
5 / 1274 (0.39%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
Acute myeloid leukaemia recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
4 / 1274 (0.31%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
Acute promyelocytic leukaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
1 / 1346 (0.07%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Adenocarcinoma gastric
|
|
|
|
|
subjects affected / exposed
|
5 / 1322 (0.38%) |
1 / 1274 (0.08%) |
3 / 1346 (0.22%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 3 |
0 / 0 |
Adenocarcinoma of appendix
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Adenocarcinoma of colon
|
|
|
|
|
subjects affected / exposed
|
9 / 1322 (0.68%) |
0 / 1274 (0.00%) |
10 / 1346 (0.74%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 0 |
0 / 11 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 0 |
0 / 5 |
0 / 1 |
Adenocarcinoma of salivary gland
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Adenocarcinoma pancreas
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
Anal cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Anal cancer recurrent
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anal cancer stage IV
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Anaplastic large cell lymphoma T- and null-cell types
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Anaplastic oligodendroglioma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Angiocentric lymphoma recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Appendix cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
3 / 1346 (0.22%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
B precursor type acute leukaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
B-cell lymphoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
9 / 1274 (0.71%) |
1 / 1346 (0.07%) |
20 / 1274 (1.57%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 9 |
0 / 1 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 3 |
B-cell lymphoma recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
3 / 1274 (0.24%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
B-cell lymphoma refractory
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
B-cell small lymphocytic lymphoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
3 / 1274 (0.24%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
B-cell unclassifiable lymphoma low grade
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Basal cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
9 / 1322 (0.68%) |
7 / 1274 (0.55%) |
9 / 1346 (0.67%) |
11 / 1274 (0.86%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 7 |
0 / 10 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Basosquamous carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Benign renal neoplasm
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bile duct cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Bladder cancer
|
|
|
|
|
subjects affected / exposed
|
5 / 1322 (0.38%) |
0 / 1274 (0.00%) |
3 / 1346 (0.22%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 1 |
0 / 0 |
Bladder neoplasm
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bowen's disease
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
4 / 1274 (0.31%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Brain cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Brain neoplasm benign
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Brain neoplasm malignant
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Breast cancer
|
|
|
|
|
subjects affected / exposed
|
94 / 1322 (7.11%) |
2 / 1274 (0.16%) |
86 / 1346 (6.39%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 98 |
0 / 2 |
0 / 89 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 47 |
0 / 0 |
0 / 52 |
0 / 0 |
Breast cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
27 / 1322 (2.04%) |
0 / 1274 (0.00%) |
40 / 1346 (2.97%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 27 |
0 / 0 |
0 / 40 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 12 |
0 / 0 |
0 / 26 |
0 / 0 |
Breast cancer recurrent
|
|
|
|
|
subjects affected / exposed
|
3 / 1322 (0.23%) |
0 / 1274 (0.00%) |
12 / 1346 (0.89%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 12 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
Breast cancer stage IV
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Breast neoplasm
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchial carcinoma
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchioloalveolar carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cancer pain
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cervix cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cervix carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
8 / 1346 (0.59%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 8 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 8 |
0 / 0 |
Cholangiocarcinoma
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
3 / 1346 (0.22%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
Cholesteatoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic lymphocytic leukaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
54 / 1274 (4.24%) |
1 / 1346 (0.07%) |
62 / 1274 (4.87%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 56 |
0 / 1 |
0 / 67 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 5 |
0 / 0 |
0 / 5 |
Chronic lymphocytic leukaemia recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
2 / 1274 (0.16%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic lymphocytic leukaemia transformation
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Chronic myeloid leukaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
5 / 1274 (0.39%) |
0 / 1346 (0.00%) |
7 / 1274 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
0 / 0 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 4 |
Chronic myelomonocytic leukaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
2 / 1274 (0.16%) |
1 / 1346 (0.07%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
Clear cell renal cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Clear cell sarcoma of soft tissue
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Colon adenoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colon cancer
|
|
|
|
|
subjects affected / exposed
|
55 / 1322 (4.16%) |
0 / 1274 (0.00%) |
63 / 1346 (4.68%) |
3 / 1274 (0.24%) |
occurrences causally related to treatment / all
|
0 / 61 |
0 / 0 |
0 / 71 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 38 |
0 / 0 |
0 / 43 |
0 / 1 |
Colon cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
33 / 1322 (2.50%) |
0 / 1274 (0.00%) |
24 / 1346 (1.78%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 35 |
0 / 0 |
0 / 27 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 25 |
0 / 0 |
0 / 12 |
0 / 0 |
Colon cancer recurrent
|
|
|
|
|
subjects affected / exposed
|
3 / 1322 (0.23%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colon cancer stage II
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colon cancer stage IV
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Colon neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Colorectal adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colorectal cancer
|
|
|
|
|
subjects affected / exposed
|
10 / 1322 (0.76%) |
0 / 1274 (0.00%) |
8 / 1346 (0.59%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 0 |
0 / 8 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 0 |
0 / 7 |
0 / 0 |
Colorectal cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
5 / 1322 (0.38%) |
0 / 1274 (0.00%) |
5 / 1346 (0.37%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 0 |
0 / 4 |
0 / 0 |
Diffuse large B-cell lymphoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
6 / 1274 (0.47%) |
0 / 1346 (0.00%) |
4 / 1274 (0.31%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 6 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Diffuse large B-cell lymphoma recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diffuse large B-cell lymphoma refractory
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ductal adenocarcinoma of pancreas
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Duodenal neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Endometrial adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
Endometrial cancer
|
|
|
|
|
subjects affected / exposed
|
5 / 1322 (0.38%) |
0 / 1274 (0.00%) |
7 / 1346 (0.52%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
0 / 7 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 5 |
0 / 0 |
Endometrial cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Endometrial cancer stage IV
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ependymoma malignant
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Epiglottic carcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Essential thrombocythaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Ewing's sarcoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Ewing's sarcoma metastatic
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Extranodal marginal zone B-cell lymphoma (MALT type)
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
2 / 1274 (0.16%) |
0 / 1346 (0.00%) |
4 / 1274 (0.31%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Extranodal marginal zone B-cell lymphoma (MALT type) recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fallopian tube cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fibrous histiocytoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gallbladder adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Gallbladder cancer
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
Gastric cancer
|
|
|
|
|
subjects affected / exposed
|
12 / 1322 (0.91%) |
0 / 1274 (0.00%) |
11 / 1346 (0.82%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 0 |
0 / 11 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 9 |
0 / 0 |
0 / 9 |
0 / 0 |
Gastric cancer recurrent
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Gastrointestinal carcinoma
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal melanoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Gastrointestinal stromal tumour
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrooesophageal cancer
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Glioblastoma
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
Glioblastoma multiforme
|
|
|
|
|
subjects affected / exposed
|
5 / 1322 (0.38%) |
0 / 1274 (0.00%) |
8 / 1346 (0.59%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
0 / 8 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 8 |
0 / 0 |
Hairy cell leukaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
2 / 1274 (0.16%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Head and neck cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic cancer
|
|
|
|
|
subjects affected / exposed
|
3 / 1322 (0.23%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatocellular carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
Hodgkin's disease
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
11 / 1274 (0.86%) |
0 / 1346 (0.00%) |
7 / 1274 (0.55%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 12 |
0 / 0 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
0 / 0 |
Hodgkin's disease lymphocyte depletion type stage unspecified
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hodgkin's disease mixed cellularity recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hodgkin's disease nodular sclerosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hodgkin's disease nodular sclerosis recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hodgkin's disease recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
3 / 1274 (0.24%) |
0 / 1346 (0.00%) |
3 / 1274 (0.24%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Intestinal adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
Intraductal proliferative breast lesion
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Invasive breast carcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Invasive ductal breast carcinoma
|
|
|
|
|
subjects affected / exposed
|
6 / 1322 (0.45%) |
1 / 1274 (0.08%) |
9 / 1346 (0.67%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
0 / 10 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
0 / 0 |
Invasive lobular breast carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Keratinising squamous cell carcinoma of nasopharynx
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Keratoacanthoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Large granular lymphocytosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Laryngeal cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
3 / 1346 (0.22%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
Laryngeal cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Leiomyosarcoma
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Leiomyosarcoma metastatic
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Lentigo maligna
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Leukaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Light chain disease
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
Lip and/or oral cavity cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Liposarcoma
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Liposarcoma recurrent
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
6 / 1322 (0.45%) |
1 / 1274 (0.08%) |
5 / 1346 (0.37%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 0 |
0 / 1 |
0 / 0 |
Lung adenocarcinoma metastatic
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
Lung adenocarcinoma recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Lung cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
6 / 1322 (0.45%) |
1 / 1274 (0.08%) |
5 / 1346 (0.37%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 5 |
0 / 0 |
Lung neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung neoplasm malignant
|
|
|
|
|
subjects affected / exposed
|
52 / 1322 (3.93%) |
3 / 1274 (0.24%) |
47 / 1346 (3.49%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 52 |
0 / 3 |
0 / 51 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 38 |
0 / 1 |
0 / 32 |
0 / 0 |
Lung squamous cell carcinoma recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung squamous cell carcinoma stage III
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Lymphocytic lymphoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lymphoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
4 / 1274 (0.31%) |
0 / 1346 (0.00%) |
6 / 1274 (0.47%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
Lymphoma transformation
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Lymphoplasmacytoid lymphoma/immunocytoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lymphoplasmacytoid lymphoma/immunocytoma recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malignant ascites
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malignant histiocytosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Malignant melanoma
|
|
|
|
|
subjects affected / exposed
|
3 / 1322 (0.23%) |
1 / 1274 (0.08%) |
6 / 1346 (0.45%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 3 |
0 / 0 |
Malignant melanoma in situ
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malignant neoplasm of ampulla of Vater
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
4 / 1346 (0.30%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 0 |
Malignant neoplasm of unknown primary site
|
|
|
|
|
subjects affected / exposed
|
3 / 1322 (0.23%) |
0 / 1274 (0.00%) |
4 / 1346 (0.30%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 3 |
0 / 0 |
Malignant peritoneal neoplasm
|
|
|
|
|
subjects affected / exposed
|
3 / 1322 (0.23%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Malignant pleural effusion
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
4 / 1346 (0.30%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Mantle cell lymphoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
5 / 1274 (0.39%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
Mantle cell lymphoma recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Medullary carcinoma of breast
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Meningioma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Meningioma malignant
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mesothelioma
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Mesothelioma malignant
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to bone
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to central nervous system
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Metastases to liver
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to lung
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to lymph nodes
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to meninges
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to ovary
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to rectum
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastatic carcinoma of the bladder
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Metastatic gastric cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
3 / 1346 (0.22%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
Metastatic malignant melanoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Metastatic neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Metastatic renal cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
3 / 1346 (0.22%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Metastatic squamous cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mucinous adenocarcinoma of appendix
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Mycosis fungoides
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Mycosis fungoides recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myelodysplastic syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
12 / 1274 (0.94%) |
0 / 1346 (0.00%) |
7 / 1274 (0.55%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 14 |
0 / 0 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 0 |
0 / 4 |
Myelodysplastic syndrome transformation
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
3 / 1274 (0.24%) |
0 / 1346 (0.00%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 2 |
Myelofibrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Myeloid leukaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Myeloproliferative neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Nasopharyngeal cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Nasopharyngeal cancer recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neuroendocrine carcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Neuroendocrine carcinoma metastatic
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
4 / 1346 (0.30%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
Neuroendocrine carcinoma of the skin
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Neuroendocrine tumour
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Non-Hodgkin's lymphoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
17 / 1274 (1.33%) |
0 / 1346 (0.00%) |
10 / 1274 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 17 |
0 / 0 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 7 |
0 / 0 |
0 / 6 |
Non-Hodgkin's lymphoma metastatic
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Non-Hodgkin's lymphoma recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
2 / 1274 (0.16%) |
0 / 1346 (0.00%) |
3 / 1274 (0.24%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Non-Hodgkin's lymphoma unspecified histology aggressive
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Non-small cell lung cancer
|
|
|
|
|
subjects affected / exposed
|
22 / 1322 (1.66%) |
1 / 1274 (0.08%) |
18 / 1346 (1.34%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 23 |
0 / 1 |
0 / 23 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 16 |
0 / 0 |
0 / 16 |
0 / 0 |
Non-small cell lung cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
3 / 1322 (0.23%) |
0 / 1274 (0.00%) |
4 / 1346 (0.30%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
Non-small cell lung cancer recurrent
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Non-small cell lung cancer stage IIIB
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
2 / 1346 (0.15%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 0 |
Oesophageal adenocarcinoma metastatic
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
3 / 1322 (0.23%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
Oesophageal carcinoma
|
|
|
|
|
subjects affected / exposed
|
5 / 1322 (0.38%) |
0 / 1274 (0.00%) |
15 / 1346 (1.11%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 0 |
0 / 15 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 12 |
0 / 0 |
Oesophageal squamous cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Oropharyngeal cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteosarcoma metastatic
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteosarcoma recurrent
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Ovarian cancer
|
|
|
|
|
subjects affected / exposed
|
27 / 1322 (2.04%) |
0 / 1274 (0.00%) |
29 / 1346 (2.15%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 30 |
0 / 0 |
0 / 32 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 15 |
0 / 0 |
0 / 20 |
0 / 0 |
Ovarian cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
6 / 1322 (0.45%) |
0 / 1274 (0.00%) |
3 / 1346 (0.22%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
0 / 0 |
Ovarian cancer recurrent
|
|
|
|
|
subjects affected / exposed
|
6 / 1322 (0.45%) |
0 / 1274 (0.00%) |
3 / 1346 (0.22%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
Ovarian epithelial cancer
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
Ovarian epithelial cancer recurrent
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatic carcinoma
|
|
|
|
|
subjects affected / exposed
|
13 / 1322 (0.98%) |
2 / 1274 (0.16%) |
17 / 1346 (1.26%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 2 |
0 / 18 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 11 |
0 / 2 |
0 / 14 |
0 / 0 |
Pancreatic carcinoma metastatic
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
5 / 1346 (0.37%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 5 |
0 / 0 |
Pancreatic carcinoma recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Pancreatic neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatic neuroendocrine tumour
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatic neuroendocrine tumour metastatic
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Papillary thyroid cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Parathyroid tumour
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral T-cell lymphoma unspecified
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Peripheral T-cell lymphoma unspecified recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peritoneal carcinoma metastatic
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Peritoneal neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pituitary tumour benign
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Plasma cell myeloma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
54 / 1274 (4.24%) |
0 / 1346 (0.00%) |
54 / 1274 (4.24%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 54 |
0 / 0 |
0 / 57 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 25 |
0 / 0 |
0 / 21 |
Plasma cell myeloma recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
8 / 1274 (0.63%) |
0 / 1346 (0.00%) |
5 / 1274 (0.39%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 8 |
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Plasmablastic lymphoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
2 / 1274 (0.16%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
Plasmacytoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Precursor T-lymphoblastic lymphoma/leukaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
3 / 1274 (0.24%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Precursor T-lymphoblastic lymphoma/leukaemia recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Prostate cancer
|
|
|
|
|
subjects affected / exposed
|
15 / 1322 (1.13%) |
5 / 1274 (0.39%) |
10 / 1346 (0.74%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 5 |
0 / 14 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 7 |
0 / 1 |
0 / 8 |
0 / 0 |
Prostate cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
4 / 1322 (0.30%) |
0 / 1274 (0.00%) |
6 / 1346 (0.45%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
Rectal adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
1 / 1274 (0.08%) |
5 / 1346 (0.37%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 5 |
0 / 0 |
Rectal cancer
|
|
|
|
|
subjects affected / exposed
|
25 / 1322 (1.89%) |
0 / 1274 (0.00%) |
17 / 1346 (1.26%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 34 |
0 / 0 |
0 / 18 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 16 |
0 / 0 |
0 / 8 |
0 / 0 |
Rectal cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
9 / 1322 (0.68%) |
0 / 1274 (0.00%) |
7 / 1346 (0.52%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 0 |
0 / 7 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 5 |
0 / 0 |
Rectal cancer recurrent
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Rectosigmoid cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Refractory anaemia with an excess of blasts
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
3 / 1274 (0.24%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
Renal cancer
|
|
|
|
|
subjects affected / exposed
|
3 / 1322 (0.23%) |
1 / 1274 (0.08%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
Renal cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Renal cancer recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
3 / 1274 (0.24%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Sarcoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Sarcoma metastatic
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Sarcoma of skin
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Schwannoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Signet-ring cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Skin cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Small cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Small cell lung cancer
|
|
|
|
|
subjects affected / exposed
|
7 / 1322 (0.53%) |
0 / 1274 (0.00%) |
6 / 1346 (0.45%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 0 |
0 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 5 |
0 / 0 |
Small cell lung cancer extensive stage
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Small cell lung cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
Small intestine adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Small intestine carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Splenic marginal zone lymphoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
3 / 1322 (0.23%) |
6 / 1274 (0.47%) |
1 / 1346 (0.07%) |
5 / 1274 (0.39%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma of head and neck
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma of lung
|
|
|
|
|
subjects affected / exposed
|
4 / 1322 (0.30%) |
0 / 1274 (0.00%) |
4 / 1346 (0.30%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 2 |
0 / 0 |
Squamous cell carcinoma of skin
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
6 / 1274 (0.47%) |
4 / 1346 (0.30%) |
10 / 1274 (0.78%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
0 / 5 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Squamous cell carcinoma of the hypopharynx
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the oral cavity
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
3 / 1346 (0.22%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the tongue
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
T-cell lymphoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
5 / 1274 (0.39%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 6 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
T-cell lymphoma recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
T-cell type acute leukaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Thymoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thyroid cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thyroid cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tongue neoplasm malignant stage unspecified
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
3 / 1346 (0.22%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
Tonsil cancer
|
|
|
|
|
subjects affected / exposed
|
3 / 1322 (0.23%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Tonsillar neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Transitional cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
3 / 1346 (0.22%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 3 |
0 / 0 |
Tumour flare
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tumour haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ureteric cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Urethral cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Uterine cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
4 / 1346 (0.30%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 1 |
Uterine leiomyosarcoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Vaginal cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Vulval cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Waldenstrom's macroglobulinaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
2 / 1274 (0.16%) |
0 / 1346 (0.00%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Vascular disorders
|
|
|
|
|
Accelerated hypertension
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic aneurysm
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic dissection
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Aortic stenosis
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arterial thrombosis
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Circulatory collapse
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Deep vein thrombosis
|
|
|
|
|
subjects affected / exposed
|
14 / 1322 (1.06%) |
6 / 1274 (0.47%) |
12 / 1346 (0.89%) |
7 / 1274 (0.55%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 6 |
0 / 12 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Embolism
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Haematoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Hypertension
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive crisis
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive emergency
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypotension
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
4 / 1346 (0.30%) |
4 / 1274 (0.31%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypovolaemic shock
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Lymphoedema
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
3 / 1346 (0.22%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Orthostatic hypotension
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
2 / 1274 (0.16%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic venous thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral arterial occlusive disease
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
2 / 1274 (0.16%) |
0 / 1346 (0.00%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery occlusion
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral embolism
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral ischaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral venous disease
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subclavian vein thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
3 / 1346 (0.22%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Superior vena cava syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
2 / 1346 (0.15%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Venous thrombosis limb
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pregnancy, puerperium and perinatal conditions
|
|
|
|
|
Abortion spontaneous
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
|
|
Adverse drug reaction
|
|
|
|
|
subjects affected / exposed
|
3 / 1322 (0.23%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Asthenia
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
4 / 1346 (0.30%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chest discomfort
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chest pain
|
|
|
|
|
subjects affected / exposed
|
6 / 1322 (0.45%) |
4 / 1274 (0.31%) |
12 / 1346 (0.89%) |
8 / 1274 (0.63%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
0 / 13 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chills
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Complication associated with device
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Death
|
|
|
|
|
subjects affected / exposed
|
31 / 1322 (2.34%) |
13 / 1274 (1.02%) |
17 / 1346 (1.26%) |
7 / 1274 (0.55%) |
occurrences causally related to treatment / all
|
0 / 31 |
0 / 13 |
0 / 17 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 31 |
0 / 13 |
0 / 17 |
0 / 7 |
Drug withdrawal syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fatigue
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gait disturbance
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
General physical health deterioration
|
|
|
|
|
subjects affected / exposed
|
5 / 1322 (0.38%) |
1 / 1274 (0.08%) |
3 / 1346 (0.22%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Generalised oedema
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Granuloma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Impaired healing
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Incarcerated hernia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
3 / 1346 (0.22%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malaise
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Medical device pain
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mucosal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mucosal inflammation
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
3 / 1346 (0.22%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Multiple organ dysfunction syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
2 / 1274 (0.16%) |
1 / 1346 (0.07%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 1 |
Nodule
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Non-cardiac chest pain
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
2 / 1346 (0.15%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
|
|
subjects affected / exposed
|
3 / 1322 (0.23%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Organ failure
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pain
|
|
|
|
|
subjects affected / exposed
|
3 / 1322 (0.23%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Polyserositis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
|
|
subjects affected / exposed
|
11 / 1322 (0.83%) |
5 / 1274 (0.39%) |
15 / 1346 (1.11%) |
13 / 1274 (1.02%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 5 |
0 / 15 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sudden death
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Systemic inflammatory response syndrome
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ulcer haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular stent thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Visceral pain
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
|
|
Anaphylactic reaction
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Drug hypersensitivity
|
|
|
|
|
subjects affected / exposed
|
4 / 1322 (0.30%) |
1 / 1274 (0.08%) |
2 / 1346 (0.15%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Graft versus host disease
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
3 / 1274 (0.24%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypersensitivity
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
1 / 1274 (0.08%) |
3 / 1346 (0.22%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypogammaglobulinaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sarcoidosis
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
|
|
Adnexa uteri mass
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Benign prostatic hyperplasia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cervical dysplasia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colpocele
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dysfunctional uterine bleeding
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Endometrial hyperplasia
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Genital erosion
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Genital lesion
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhagic ovarian cyst
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metrorrhagia
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ovarian cyst
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
1 / 1274 (0.08%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ovarian disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ovarian mass
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Postmenopausal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prostatic disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prostatic dysplasia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Testicular pain
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vaginal disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vaginal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
|
Acute interstitial pneumonitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute pulmonary oedema
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Acute respiratory distress syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
2 / 1274 (0.16%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
Acute respiratory failure
|
|
|
|
|
subjects affected / exposed
|
9 / 1322 (0.68%) |
0 / 1274 (0.00%) |
3 / 1346 (0.22%) |
4 / 1274 (0.31%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 0 |
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 0 |
0 / 1 |
0 / 0 |
Alveolitis allergic
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Apnoea
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Aspiration
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Asthma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
4 / 1346 (0.30%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atelectasis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchial hyperreactivity
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic obstructive pulmonary disease
|
|
|
|
|
subjects affected / exposed
|
10 / 1322 (0.76%) |
8 / 1274 (0.63%) |
10 / 1346 (0.74%) |
7 / 1274 (0.55%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 19 |
0 / 13 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
Chronic respiratory failure
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
Chylothorax
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cough
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
|
|
subjects affected / exposed
|
5 / 1322 (0.38%) |
1 / 1274 (0.08%) |
6 / 1346 (0.45%) |
4 / 1274 (0.31%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Dyspnoea exertional
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Emphysema
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
Epistaxis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
2 / 1346 (0.15%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Haemoptysis
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
3 / 1346 (0.22%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemothorax
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypoxia
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
2 / 1274 (0.16%) |
2 / 1346 (0.15%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Idiopathic pulmonary fibrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Interstitial lung disease
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung infiltration
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
2 / 1274 (0.16%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nasal septum deviation
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Obstructive airways disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Organising pneumonia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Paranasal sinus mucosal hypertrophy
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
|
|
subjects affected / exposed
|
11 / 1322 (0.83%) |
5 / 1274 (0.39%) |
12 / 1346 (0.89%) |
10 / 1274 (0.78%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 5 |
0 / 14 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
Pneumonia aspiration
|
|
|
|
|
subjects affected / exposed
|
3 / 1322 (0.23%) |
1 / 1274 (0.08%) |
4 / 1346 (0.30%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 8 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
Pneumonia lipoid
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonitis
|
|
|
|
|
subjects affected / exposed
|
4 / 1322 (0.30%) |
1 / 1274 (0.08%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Pneumothorax
|
|
|
|
|
subjects affected / exposed
|
3 / 1322 (0.23%) |
1 / 1274 (0.08%) |
5 / 1346 (0.37%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
Pulmonary embolism
|
|
|
|
|
subjects affected / exposed
|
28 / 1322 (2.12%) |
7 / 1274 (0.55%) |
19 / 1346 (1.41%) |
5 / 1274 (0.39%) |
occurrences causally related to treatment / all
|
0 / 28 |
0 / 7 |
0 / 20 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 1 |
0 / 1 |
Pulmonary fibrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
1 / 1346 (0.07%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Pulmonary hypertension
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary infarction
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary mass
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary oedema
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary toxicity
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Reactive airways dysfunction syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiration abnormal
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory acidosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory distress
|
|
|
|
|
subjects affected / exposed
|
3 / 1322 (0.23%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
Respiratory failure
|
|
|
|
|
subjects affected / exposed
|
6 / 1322 (0.45%) |
2 / 1274 (0.16%) |
8 / 1346 (0.59%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
0 / 8 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 6 |
0 / 0 |
Sleep apnoea syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tracheal stenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vocal cord thickening
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
|
|
Adjustment disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anxiety
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Confusional state
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Delirium
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Depression
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
1 / 1346 (0.07%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Major depression
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mania
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mental disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mental status changes
|
|
|
|
|
subjects affected / exposed
|
5 / 1322 (0.38%) |
0 / 1274 (0.00%) |
4 / 1346 (0.30%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mood altered
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Somatic symptom disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Suicide attempt
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Product issues
|
|
|
|
|
Device dislocation
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
3 / 1346 (0.22%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device failure
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device leakage
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device malfunction
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device occlusion
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
3 / 1346 (0.22%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Stent malfunction
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thrombosis in device
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
|
|
Acute hepatic failure
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Bile duct obstruction
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
3 / 1346 (0.22%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bile duct stone
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Biliary colic
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Biloma
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholangitis
|
|
|
|
|
subjects affected / exposed
|
4 / 1322 (0.30%) |
0 / 1274 (0.00%) |
7 / 1346 (0.52%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
0 / 8 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholangitis acute
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
2 / 1274 (0.16%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis acute
|
|
|
|
|
subjects affected / exposed
|
3 / 1322 (0.23%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis chronic
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
2 / 1274 (0.16%) |
1 / 1346 (0.07%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholestasis
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Drug-induced liver injury
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gallbladder disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemobilia
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic cirrhosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
1 / 1346 (0.07%) |
3 / 1274 (0.24%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 2 |
Hepatic failure
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic function abnormal
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis cholestatic
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatorenal syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatotoxicity
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Hyperbilirubinaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Jaundice cholestatic
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Liver injury
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Portal vein thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Investigations
|
|
|
|
|
CSF test abnormal
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oxygen saturation decreased
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prothrombin time abnormal
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Troponin increased
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
|
|
Abdominal wound dehiscence
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Accidental overdose
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acetabulum fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anastomotic stenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ankle fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
4 / 1346 (0.30%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cervical vertebral fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chemical peritonitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Compression fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Concussion
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Contusion
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Craniocerebral injury
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Cystitis radiation
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Eschar
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Eye contusion
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fall
|
|
|
|
|
subjects affected / exposed
|
3 / 1322 (0.23%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Femoral neck fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
3 / 1274 (0.24%) |
5 / 1346 (0.37%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fibula fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Foot fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis radiation
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal stoma complication
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
1 / 1274 (0.08%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Head injury
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Heat exhaustion
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hip fracture
|
|
|
|
|
subjects affected / exposed
|
5 / 1322 (0.38%) |
1 / 1274 (0.08%) |
3 / 1346 (0.22%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Humerus fracture
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Incarcerated incisional hernia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Incisional hernia
|
|
|
|
|
subjects affected / exposed
|
3 / 1322 (0.23%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infusion related reaction
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intentional overdose
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Joint dislocation
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Joint injury
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Laceration
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ligament rupture
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lower limb fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar vertebral fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Muscle rupture
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteoradionecrosis
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Overdose
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Periorbital haematoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural bile leak
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural discharge
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural fistula
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural haematoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural haematuria
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural haemorrhage
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
3 / 1274 (0.24%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative fever
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative ileus
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative respiratory distress
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Procedural hypotension
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Procedural pneumothorax
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
3 / 1346 (0.22%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Radiation necrosis
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Radiation oesophagitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Radiation pericarditis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Radiation pneumonitis
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
1 / 1274 (0.08%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Radius fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
2 / 1274 (0.16%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Road traffic accident
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Seroma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin wound
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal column injury
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
|
|
subjects affected / exposed
|
3 / 1322 (0.23%) |
2 / 1274 (0.16%) |
0 / 1346 (0.00%) |
3 / 1274 (0.24%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sternal fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Stoma site haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Stomal hernia
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Stress fracture
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subarachnoid haemorrhage
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subcutaneous haematoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subdural haematoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
2 / 1274 (0.16%) |
0 / 1346 (0.00%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subdural haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thermal burn
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thoracic vertebral fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tibia fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Toxicity to various agents
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
3 / 1274 (0.24%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Transplant dysfunction
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic haematoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic haemothorax
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Upper limb fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary retention postoperative
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urostomy complication
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wound
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wound dehiscence
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wrist fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
|
|
Dysplastic naevus syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Tracheo-oesophageal fistula
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
|
|
Acute coronary syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute myocardial infarction
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
6 / 1274 (0.47%) |
6 / 1346 (0.45%) |
5 / 1274 (0.39%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Angina pectoris
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Angina unstable
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic valve sclerosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic valve stenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arrhythmia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Atrial fibrillation
|
|
|
|
|
subjects affected / exposed
|
7 / 1322 (0.53%) |
9 / 1274 (0.71%) |
11 / 1346 (0.82%) |
15 / 1274 (1.18%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 12 |
0 / 11 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrial flutter
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
3 / 1274 (0.24%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular block second degree
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac arrest
|
|
|
|
|
subjects affected / exposed
|
8 / 1322 (0.61%) |
4 / 1274 (0.31%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 8 |
0 / 3 |
0 / 0 |
0 / 0 |
Cardiac failure
|
|
|
|
|
subjects affected / exposed
|
6 / 1322 (0.45%) |
3 / 1274 (0.24%) |
4 / 1346 (0.30%) |
3 / 1274 (0.24%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Cardiac failure acute
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac failure chronic
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac failure congestive
|
|
|
|
|
subjects affected / exposed
|
9 / 1322 (0.68%) |
11 / 1274 (0.86%) |
6 / 1346 (0.45%) |
10 / 1274 (0.78%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 12 |
0 / 7 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 2 |
Cardiac tamponade
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac valve disease
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Cardiac ventricular thrombosis
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardio-respiratory arrest
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
1 / 1274 (0.08%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
0 / 0 |
Cardiomyopathy
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiomyopathy acute
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiopulmonary failure
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Cardiorenal syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Congestive cardiomyopathy
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery disease
|
|
|
|
|
subjects affected / exposed
|
3 / 1322 (0.23%) |
3 / 1274 (0.24%) |
2 / 1346 (0.15%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Coronary artery insufficiency
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic cardiomyopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
2 / 1274 (0.16%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Mitral valve incompetence
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myocardial infarction
|
|
|
|
|
subjects affected / exposed
|
3 / 1322 (0.23%) |
4 / 1274 (0.31%) |
4 / 1346 (0.30%) |
4 / 1274 (0.31%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
0 / 1 |
Myocardial ischaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Palpitations
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pericardial effusion
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
1 / 1274 (0.08%) |
1 / 1346 (0.07%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pericardial haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pericarditis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Pulseless electrical activity
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Sinus node dysfunction
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sinus tachycardia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Stress cardiomyopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
2 / 1274 (0.16%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular dyssynchrony
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular extrasystoles
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular fibrillation
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular tachycardia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
|
|
Aphasia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Autonomic nervous system imbalance
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Brain oedema
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Carotid artery aneurysm
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Carotid artery stenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebellar infarction
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral haematoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
Cerebral infarction
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral microangiopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebrovascular accident
|
|
|
|
|
subjects affected / exposed
|
8 / 1322 (0.61%) |
4 / 1274 (0.31%) |
5 / 1346 (0.37%) |
3 / 1274 (0.24%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 4 |
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
0 / 0 |
Cervical cord compression
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cognitive disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cubital tunnel syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dementia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dementia Alzheimer's type
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Depressed level of consciousness
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic coma
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dizziness
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Embolic stroke
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Encephalopathy
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
3 / 1346 (0.22%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Facial paralysis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
3 / 1346 (0.22%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Guillain-Barre syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhage intracranial
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Headache
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
3 / 1274 (0.24%) |
5 / 1346 (0.37%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hemiparesis
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic encephalopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypoglycaemic coma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypoxic-ischaemic encephalopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Intensive care unit acquired weakness
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intracranial haematoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Intraventricular haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Ischaemic stroke
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
2 / 1274 (0.16%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar radiculopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Meningeal disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Migraine
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myelitis transverse
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nervous system disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neuralgia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neuropathy peripheral
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Parkinson's disease
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Polyneuropathy
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post herpetic neuralgia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Posterior reversible encephalopathy syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Presyncope
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sciatica
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Seizure
|
|
|
|
|
subjects affected / exposed
|
6 / 1322 (0.45%) |
2 / 1274 (0.16%) |
5 / 1346 (0.37%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Senile dementia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Serotonin syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Simple partial seizures
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal cord compression
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Syncope
|
|
|
|
|
subjects affected / exposed
|
5 / 1322 (0.38%) |
1 / 1274 (0.08%) |
3 / 1346 (0.22%) |
5 / 1274 (0.39%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Toxic encephalopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
3 / 1346 (0.22%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
5 / 1274 (0.39%) |
1 / 1346 (0.07%) |
3 / 1274 (0.24%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vasogenic cerebral oedema
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vocal cord paralysis
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
|
|
Anaemia
|
|
|
|
|
subjects affected / exposed
|
9 / 1322 (0.68%) |
16 / 1274 (1.26%) |
24 / 1346 (1.78%) |
11 / 1274 (0.86%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 19 |
0 / 25 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Anaemia of chronic disease
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
3 / 1346 (0.22%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anaemia of malignant disease
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Autoimmune haemolytic anaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
2 / 1274 (0.16%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bone marrow failure
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Coagulopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Febrile neutropenia
|
|
|
|
|
subjects affected / exposed
|
21 / 1322 (1.59%) |
44 / 1274 (3.45%) |
35 / 1346 (2.60%) |
35 / 1274 (2.75%) |
occurrences causally related to treatment / all
|
0 / 23 |
0 / 64 |
0 / 37 |
1 / 43 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 2 |
0 / 1 |
Haematotoxicity
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Haemolysis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemolytic anaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhagic anaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypoprothrombinaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Iron deficiency anaemia
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Leukocytosis
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Leukopenia
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
1 / 1346 (0.07%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lymph node pain
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lymphadenitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lymphadenopathy
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
1 / 1346 (0.07%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neutropenia
|
|
|
|
|
subjects affected / exposed
|
4 / 1322 (0.30%) |
4 / 1274 (0.31%) |
5 / 1346 (0.37%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
|
|
subjects affected / exposed
|
7 / 1322 (0.53%) |
5 / 1274 (0.39%) |
9 / 1346 (0.67%) |
5 / 1274 (0.39%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
0 / 12 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Splenomegaly
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
|
|
subjects affected / exposed
|
5 / 1322 (0.38%) |
4 / 1274 (0.31%) |
5 / 1346 (0.37%) |
4 / 1274 (0.31%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 5 |
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
|
|
Inner ear disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neurosensory hypoacusis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vertigo
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vertigo positional
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
|
|
Blindness transient
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cataract
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cortical visual impairment
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myopia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Necrotising retinitis
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Retinal detachment
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ulcerative keratitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
|
|
Abdominal hernia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal hernia obstructive
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
|
|
subjects affected / exposed
|
9 / 1322 (0.68%) |
3 / 1274 (0.24%) |
7 / 1346 (0.52%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 3 |
0 / 8 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain lower
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
1 / 1274 (0.08%) |
4 / 1346 (0.30%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal wall haematoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anal fissure
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anal fistula
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ascites
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
2 / 1274 (0.16%) |
3 / 1346 (0.22%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colitis ischaemic
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Constipation
|
|
|
|
|
subjects affected / exposed
|
7 / 1322 (0.53%) |
1 / 1274 (0.08%) |
8 / 1346 (0.59%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 1 |
0 / 8 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Crohn's disease
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cyclic vomiting syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
|
|
subjects affected / exposed
|
17 / 1322 (1.29%) |
1 / 1274 (0.08%) |
13 / 1346 (0.97%) |
3 / 1274 (0.24%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 1 |
0 / 15 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diarrhoea haemorrhagic
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diverticular perforation
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulum
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulum intestinal
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Duodenal obstruction
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Duodenal ulcer haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Duodenitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dyspepsia
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dysphagia
|
|
|
|
|
subjects affected / exposed
|
3 / 1322 (0.23%) |
0 / 1274 (0.00%) |
5 / 1346 (0.37%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Enteritis
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Enterocutaneous fistula
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Eosinophilic colitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Erosive oesophagitis
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Faecaloma
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastric ulcer haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastritis
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastritis erosive
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
7 / 1322 (0.53%) |
6 / 1274 (0.47%) |
13 / 1346 (0.97%) |
5 / 1274 (0.39%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 6 |
0 / 13 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 4 |
0 / 1 |
Gastrointestinal hypomotility
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal obstruction
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal pain
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal perforation
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haematemesis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haematochezia
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhoidal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhoids
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hiatus hernia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ileus
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
4 / 1346 (0.30%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Impaired gastric emptying
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Incarcerated inguinal hernia
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal hernia strangulated
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal fibrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal ischaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal obstruction
|
|
|
|
|
subjects affected / exposed
|
12 / 1322 (0.91%) |
3 / 1274 (0.24%) |
10 / 1346 (0.74%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 4 |
0 / 12 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal perforation
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal prolapse
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Large intestinal obstruction
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Large intestine perforation
|
|
|
|
|
subjects affected / exposed
|
3 / 1322 (0.23%) |
1 / 1274 (0.08%) |
1 / 1346 (0.07%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Large intestine polyp
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lower gastrointestinal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
2 / 1274 (0.16%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mallory-Weiss syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mouth ulceration
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nausea
|
|
|
|
|
subjects affected / exposed
|
4 / 1322 (0.30%) |
1 / 1274 (0.08%) |
5 / 1346 (0.37%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neutropenic colitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
3 / 1274 (0.24%) |
1 / 1346 (0.07%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Obstruction gastric
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Odynophagia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal perforation
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal rupture
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal spasm
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal ulcer haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Oesophageal varices haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oesophagitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatic cyst
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatic insufficiency
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatic mass
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
|
|
subjects affected / exposed
|
4 / 1322 (0.30%) |
1 / 1274 (0.08%) |
2 / 1346 (0.15%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis acute
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
3 / 1346 (0.22%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis chronic
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Proctalgia
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Proctitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
3 / 1274 (0.24%) |
3 / 1346 (0.22%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal ulcer
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Retroperitoneal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
1 / 1346 (0.07%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Salivary gland calculus
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
|
|
subjects affected / exposed
|
21 / 1322 (1.59%) |
4 / 1274 (0.31%) |
12 / 1346 (0.89%) |
5 / 1274 (0.39%) |
occurrences causally related to treatment / all
|
0 / 43 |
0 / 4 |
0 / 17 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
Small intestinal perforation
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Stomatitis
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
4 / 1346 (0.30%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subileus
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Umbilical hernia
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
3 / 1274 (0.24%) |
1 / 1346 (0.07%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Volvulus
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vomiting
|
|
|
|
|
subjects affected / exposed
|
11 / 1322 (0.83%) |
2 / 1274 (0.16%) |
13 / 1346 (0.97%) |
3 / 1274 (0.24%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 4 |
0 / 16 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
|
|
Angioedema
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Brow ptosis
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Decubitus ulcer
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Drug reaction with eosinophilia and systemic symptoms
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Eczema nummular
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Generalised erythema
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pruritus
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pyoderma gangrenosum
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rash
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rash maculo-papular
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rash vesicular
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin exfoliation
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin necrosis
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin reaction
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin ulcer
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Stasis dermatitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Stevens-Johnson syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Swelling face
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Toxic epidermal necrolysis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urticaria
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
|
|
Acute kidney injury
|
|
|
|
|
subjects affected / exposed
|
12 / 1322 (0.91%) |
10 / 1274 (0.78%) |
18 / 1346 (1.34%) |
10 / 1274 (0.78%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 11 |
0 / 20 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
0 / 1 |
Chronic kidney disease
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
3 / 1274 (0.24%) |
2 / 1346 (0.15%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
End stage renal disease
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
2 / 1274 (0.16%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Haematuria
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
3 / 1346 (0.22%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
|
|
subjects affected / exposed
|
4 / 1322 (0.30%) |
0 / 1274 (0.00%) |
4 / 1346 (0.30%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypercalcaemic nephropathy
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Incontinence
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Micturition disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
2 / 1274 (0.16%) |
3 / 1346 (0.22%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Obstructive uropathy
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal failure
|
|
|
|
|
subjects affected / exposed
|
5 / 1322 (0.38%) |
2 / 1274 (0.16%) |
6 / 1346 (0.45%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Renal impairment
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Stag horn calculus
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ureteric obstruction
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ureterolithiasis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary bladder haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary retention
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
1 / 1274 (0.08%) |
1 / 1346 (0.07%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract obstruction
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Endocrine disorders
|
|
|
|
|
Adrenal insufficiency
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Carcinoid syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cushing's syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Goitre
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypercalcaemia of malignancy
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
2 / 1274 (0.16%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperthyroidism
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypothyroidism
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Inappropriate antidiuretic hormone secretion
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thyroid mass
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
|
|
Ankylosing spondylitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arthralgia
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arthropathy
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Back pain
|
|
|
|
|
subjects affected / exposed
|
4 / 1322 (0.30%) |
1 / 1274 (0.08%) |
3 / 1346 (0.22%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bone cyst
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fistula
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fracture delayed union
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemarthrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral disc disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
3 / 1274 (0.24%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar spinal stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Muscle haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Muscle spasms
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Muscular weakness
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
2 / 1346 (0.15%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal chest pain
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal pain
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neck pain
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
|
|
subjects affected / exposed
|
3 / 1322 (0.23%) |
0 / 1274 (0.00%) |
5 / 1346 (0.37%) |
4 / 1274 (0.31%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteolysis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteonecrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
2 / 1274 (0.16%) |
3 / 1346 (0.22%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pathological fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Polyarthritis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rhabdomyolysis
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rheumatoid arthritis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rotator cuff syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sacroiliitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Soft tissue mass
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal osteoarthritis
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spondylolisthesis
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Synovial cyst
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vertebral foraminal stenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
|
|
Abdominal abscess
|
|
|
|
|
subjects affected / exposed
|
3 / 1322 (0.23%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal sepsis
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal wall abscess
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abscess jaw
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abscess limb
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abscess soft tissue
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anal abscess
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
2 / 1274 (0.16%) |
6 / 1346 (0.45%) |
3 / 1274 (0.24%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Appendicitis perforated
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis bacterial
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis infective
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atypical pneumonia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bacillus bacteraemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bacteraemia
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
6 / 1346 (0.45%) |
3 / 1274 (0.24%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bacterial sepsis
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
3 / 1274 (0.24%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
Bacterial tracheitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Biliary sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Breast abscess
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Breast cellulitis
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchiolitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
10 / 1274 (0.78%) |
6 / 1346 (0.45%) |
6 / 1274 (0.47%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 10 |
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchopulmonary aspergillosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
3 / 1274 (0.24%) |
0 / 1346 (0.00%) |
4 / 1274 (0.31%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Campylobacter gastroenteritis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
|
|
subjects affected / exposed
|
12 / 1322 (0.91%) |
13 / 1274 (1.02%) |
19 / 1346 (1.41%) |
13 / 1274 (1.02%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 18 |
0 / 21 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Cellulitis staphylococcal
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral aspergillosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Chronic sinusitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Citrobacter sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Clostridial infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Clostridial sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium difficile colitis
|
|
|
|
|
subjects affected / exposed
|
9 / 1322 (0.68%) |
2 / 1274 (0.16%) |
5 / 1346 (0.37%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 2 |
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium difficile infection
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
1 / 1274 (0.08%) |
4 / 1346 (0.30%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cystitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dengue fever
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device related infection
|
|
|
|
|
subjects affected / exposed
|
7 / 1322 (0.53%) |
4 / 1274 (0.31%) |
10 / 1346 (0.74%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 5 |
0 / 10 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device related sepsis
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diarrhoea infectious
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
3 / 1274 (0.24%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Disseminated cryptococcosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
4 / 1346 (0.30%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Empyema
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Encephalitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Endocarditis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Endophthalmitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Enteritis infectious
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Enterococcal sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
2 / 1274 (0.16%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Epididymitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Escherichia bacteraemia
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
1 / 1346 (0.07%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Escherichia infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Escherichia sepsis
|
|
|
|
|
subjects affected / exposed
|
4 / 1322 (0.30%) |
2 / 1274 (0.16%) |
2 / 1346 (0.15%) |
4 / 1274 (0.31%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Escherichia urinary tract infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Extradural abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Febrile infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fungaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Fungal oesophagitis
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
|
|
subjects affected / exposed
|
6 / 1322 (0.45%) |
5 / 1274 (0.39%) |
5 / 1346 (0.37%) |
4 / 1274 (0.31%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis rotavirus
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis salmonella
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis viral
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
1 / 1346 (0.07%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Genital herpes
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Groin abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
H1N1 influenza
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haematoma infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemophilus bacteraemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis B
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis C
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Hepatosplenic candidiasis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Herpes virus infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Herpes zoster
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
4 / 1274 (0.31%) |
1 / 1346 (0.07%) |
4 / 1274 (0.31%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 4 |
0 / 1 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Herpes zoster disseminated
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
2 / 1274 (0.16%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Herpes zoster oticus
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Implant site infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infected bite
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
2 / 1274 (0.16%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infected fistula
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infected seroma
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infectious colitis
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infectious pleural effusion
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infective exacerbation of chronic obstructive airways disease
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Influenza
|
|
|
|
|
subjects affected / exposed
|
3 / 1322 (0.23%) |
4 / 1274 (0.31%) |
3 / 1346 (0.22%) |
6 / 1274 (0.47%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Intestinal fistula infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Joint abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Kidney infection
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Klebsiella bacteraemia
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
2 / 1346 (0.15%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Klebsiella sepsis
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Labyrinthitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Listeria sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lower respiratory tract infection
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
3 / 1274 (0.24%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lower respiratory tract infection bacterial
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lower respiratory tract infection fungal
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Lung infection pseudomonal
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mediastinitis
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Meningitis aseptic
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Meningitis cryptococcal
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Meningoencephalitis herpetic
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metapneumovirus infection
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Muscle abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
2 / 1274 (0.16%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nasopharyngitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Necrotising fasciitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
3 / 1346 (0.22%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Neutropenic sepsis
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ophthalmic herpes zoster
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Orchitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Otitis media
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Paraspinal abscess
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic abscess
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
4 / 1346 (0.30%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Pelvic inflammatory disease
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Periodontitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Periorbital cellulitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Perirectal abscess
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peritonitis
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peritonitis bacterial
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peritonsillar abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pharyngitis streptococcal
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pilonidal cyst
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pleurisy viral
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumocystis jirovecii pneumonia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
2 / 1274 (0.16%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
|
|
subjects affected / exposed
|
49 / 1322 (3.71%) |
72 / 1274 (5.65%) |
49 / 1346 (3.64%) |
66 / 1274 (5.18%) |
occurrences causally related to treatment / all
|
0 / 57 |
1 / 83 |
0 / 53 |
0 / 87 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 14 |
0 / 9 |
0 / 9 |
Pneumonia bacterial
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
2 / 1274 (0.16%) |
1 / 1346 (0.07%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Pneumonia cytomegaloviral
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia fungal
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
2 / 1274 (0.16%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia influenzal
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia klebsiella
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia moraxella
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia mycoplasmal
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia necrotising
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
2 / 1274 (0.16%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia pneumococcal
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Pneumonia pseudomonal
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia streptococcal
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
2 / 1274 (0.16%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural cellulitis
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural infection
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative wound infection
|
|
|
|
|
subjects affected / exposed
|
3 / 1322 (0.23%) |
0 / 1274 (0.00%) |
3 / 1346 (0.22%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Progressive multifocal leukoencephalopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Pseudomembranous colitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pseudomonal bacteraemia
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pseudomonal sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Psoas abscess
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
4 / 1274 (0.31%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
Pyelonephritis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pyelonephritis acute
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pyomyositis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Rectal abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory moniliasis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory syncytial virus infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
1 / 1274 (0.08%) |
3 / 1346 (0.22%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory tract infection bacterial
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rhinovirus infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Scrotal infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sepsis
|
|
|
|
|
subjects affected / exposed
|
28 / 1322 (2.12%) |
17 / 1274 (1.33%) |
21 / 1346 (1.56%) |
21 / 1274 (1.65%) |
occurrences causally related to treatment / all
|
0 / 32 |
1 / 18 |
0 / 23 |
0 / 22 |
deaths causally related to treatment / all
|
0 / 8 |
0 / 4 |
0 / 4 |
0 / 9 |
Sepsis syndrome
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Septic shock
|
|
|
|
|
subjects affected / exposed
|
6 / 1322 (0.45%) |
7 / 1274 (0.55%) |
7 / 1346 (0.52%) |
10 / 1274 (0.78%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
0 / 7 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 2 |
0 / 3 |
0 / 7 |
Serratia bacteraemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Serratia sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sinusitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin infection
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Soft tissue infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Splenic abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal bacteraemia
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
2 / 1274 (0.16%) |
1 / 1346 (0.07%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal skin infection
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Stenotrophomonas sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subcutaneous abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tonsillitis bacterial
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tooth abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tuberculosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Upper respiratory tract infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
2 / 1274 (0.16%) |
2 / 1346 (0.15%) |
4 / 1274 (0.31%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
|
|
subjects affected / exposed
|
19 / 1322 (1.44%) |
11 / 1274 (0.86%) |
24 / 1346 (1.78%) |
11 / 1274 (0.86%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 11 |
0 / 24 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Urinary tract infection bacterial
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract infection fungal
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract infection staphylococcal
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
|
|
subjects affected / exposed
|
3 / 1322 (0.23%) |
2 / 1274 (0.16%) |
6 / 1346 (0.45%) |
4 / 1274 (0.31%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Varicella
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Varicella zoster pneumonia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
Viraemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Viral infection
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Viral upper respiratory tract infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vulval abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
West Nile viral infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Wound abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wound infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
|
|
Decreased appetite
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dehydration
|
|
|
|
|
subjects affected / exposed
|
16 / 1322 (1.21%) |
2 / 1274 (0.16%) |
17 / 1346 (1.26%) |
2 / 1274 (0.16%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 2 |
0 / 18 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetes mellitus inadequate control
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic ketoacidosis
|
|
|
|
|
subjects affected / exposed
|
3 / 1322 (0.23%) |
0 / 1274 (0.00%) |
3 / 1346 (0.22%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Electrolyte imbalance
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Failure to thrive
|
|
|
|
|
subjects affected / exposed
|
3 / 1322 (0.23%) |
1 / 1274 (0.08%) |
3 / 1346 (0.22%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fluid overload
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
2 / 1274 (0.16%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Food intolerance
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gout
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypercalcaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
3 / 1346 (0.22%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
1 / 1346 (0.07%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypocalcaemia
|
|
|
|
|
subjects affected / exposed
|
3 / 1322 (0.23%) |
0 / 1274 (0.00%) |
2 / 1346 (0.15%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
|
|
subjects affected / exposed
|
3 / 1322 (0.23%) |
1 / 1274 (0.08%) |
3 / 1346 (0.22%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
7 / 1274 (0.55%) |
6 / 1346 (0.45%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 9 |
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypomagnesaemia
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
0 / 1274 (0.00%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
|
|
subjects affected / exposed
|
2 / 1322 (0.15%) |
2 / 1274 (0.16%) |
2 / 1346 (0.15%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypovolaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 1322 (0.08%) |
0 / 1274 (0.00%) |
1 / 1346 (0.07%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malnutrition
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
0 / 1274 (0.00%) |
3 / 1346 (0.22%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metabolic alkalosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
0 / 1274 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tumour lysis syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 1322 (0.00%) |
1 / 1274 (0.08%) |
0 / 1346 (0.00%) |
1 / 1274 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |