Serious adverse events
|
Paediatric GHD |
Paediatric SGA |
Paediatric TS |
Paediatric CRD |
Paediatric ISS |
Paediatric NS |
Paediatric PWS |
Paediatric Other |
Adult GHD |
Adult Other |
Total subjects affected by serious adverse events
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
174 / 9996 (1.74%) |
51 / 4274 (1.19%) |
30 / 1374 (2.18%) |
7 / 290 (2.41%) |
9 / 485 (1.86%) |
3 / 154 (1.95%) |
11 / 132 (8.33%) |
18 / 1035 (1.74%) |
133 / 2321 (5.73%) |
10 / 163 (6.13%) |
number of deaths (all causes)
|
4 |
1 |
0 |
2 |
0 |
0 |
1 |
3 |
14 |
0 |
number of deaths resulting from adverse events
|
1 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
2 |
0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
|
|
|
|
|
|
|
Acute myeloid leukaemia
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Adenoma benign
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anaplastic astrocytoma
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
Angiosarcoma metastatic
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
1 / 1374 (0.07%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Astrocytoma malignant
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Benign neoplasm
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder neoplasm
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Brain neoplasm
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
3 / 9996 (0.03%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchial carcinoma
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Burkitt's lymphoma
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Choroid plexus carcinoma
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colon cancer metastatic
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
Craniopharyngioma
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
3 / 9996 (0.03%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Craniopharyngioma benign
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Enchondromatosis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Follicle centre lymphoma, follicular grade I, II, III
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastric cancer stage 0
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Glioma
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
1 / 1035 (0.10%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Glioneuronal tumour
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
1 / 154 (0.65%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemangioma
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 9996 (0.02%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hodgkin's disease
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intraductal papillary mucinous neoplasm
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lipoma
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lymphocytic leukaemia
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malignant melanoma
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
1 / 163 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Mantle cell lymphoma
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Medulloblastoma recurrent
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
1 / 1035 (0.10%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Metastases to meninges
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to spine
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Multiple myeloma
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myelofibrosis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nasal sinus cancer
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neoplasm
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neoplasm malignant
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
3 / 9996 (0.03%) |
0 / 4274 (0.00%) |
1 / 1374 (0.07%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
9 / 2321 (0.39%) |
1 / 163 (0.61%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
4 / 11 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
Neoplasm progression
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
3 / 9996 (0.03%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
1 / 1035 (0.10%) |
3 / 2321 (0.13%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
2 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neoplasm recurrence
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
2 / 1035 (0.19%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Nephroblastoma
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Non-secretory adenoma of pituitary
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
2 / 2321 (0.09%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oral neoplasm benign
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Papillary renal cell carcinoma
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Papillary thyroid cancer
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pituitary tumour
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
3 / 2321 (0.13%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pituitary tumour benign
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
3 / 2321 (0.13%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
2 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Primitive neuroectodermal tumour
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
1 / 485 (0.21%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
2 / 1035 (0.19%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Prostate cancer
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Recurrent cancer
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 9996 (0.02%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal cancer
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal cell carcinoma
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Schwannoma
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
T-cell lymphoma
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
|
|
|
|
|
|
|
|
Deep vein thrombosis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
1 / 163 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhage
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
1 / 1035 (0.10%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Hypertension
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
1 / 1374 (0.07%) |
1 / 290 (0.34%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypotension
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Shock
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Venous thrombosis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Venous thrombosis limb
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
|
|
|
|
|
|
|
|
Adenoidectomy
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Adenotonsillectomy
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
1 / 1035 (0.10%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bone lesion excision
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystectomy
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
2 / 2321 (0.09%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystostomy
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ear operation
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrostomy closure
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
1 / 290 (0.34%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hip surgery
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hospitalisation
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Limb operation
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myringotomy
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Orchidopexy
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peritoneal dialysis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
1 / 290 (0.34%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pituitary tumour removal
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Plastic surgery to the face
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal transplant
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
1 / 290 (0.34%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
1 / 1035 (0.10%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rotator cuff repair
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal fusion surgery
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
1 / 154 (0.65%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Strabismus correction
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular septal defect repair
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wisdom teeth removal
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pregnancy, puerperium and perinatal conditions
|
|
|
|
|
|
|
|
|
|
|
Pre-eclampsia
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
|
|
|
|
|
|
|
|
Asthenia
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chest pain
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
2 / 2321 (0.09%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Condition aggravated
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 9996 (0.02%) |
2 / 4274 (0.05%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
1 / 154 (0.65%) |
2 / 132 (1.52%) |
1 / 1035 (0.10%) |
3 / 2321 (0.13%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 2 |
0 / 1 |
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Death
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
4 / 2321 (0.17%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 4 |
0 / 0 |
Discomfort
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Disease recurrence
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
3 / 9996 (0.03%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Face oedema
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
1 / 290 (0.34%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fatigue
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 9996 (0.02%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
General physical health deterioration
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperthermia
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 9996 (0.02%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Injection site atrophy
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malaise
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 9996 (0.02%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oedema
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 9996 (0.02%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral swelling
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
3 / 9996 (0.03%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sudden death
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
1 / 132 (0.76%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
|
|
|
|
|
|
|
|
Ovarian cyst
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ovarian disorder
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
1 / 1374 (0.07%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Varicocele
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
|
|
|
|
|
|
|
Adenoidal disorder
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
1 / 1374 (0.07%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Asthma
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
1 / 132 (0.76%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dysphonia
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperventilation
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung disorder
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
1 / 1374 (0.07%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oropharyngeal pain
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumothorax
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary artery wall hypertrophy
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary oedema
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
1 / 290 (0.34%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory failure
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rhinorrhoea
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sleep apnoea syndrome
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
1 / 132 (0.76%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Stridor
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tonsillar hypertrophy
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
|
|
|
|
|
|
|
|
Anxiety
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Completed suicide
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Depression
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
3 / 2321 (0.13%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mental disorder
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Restlessness
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Screaming
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sleep disorder
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Stress
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Suicide attempt
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tic
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Product issues
|
|
|
|
|
|
|
|
|
|
|
Device malfunction
|
|
|
|
|
|
|
|
|
|
|
alternative dictionary used: MedDRA
3
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
1 / 485 (0.21%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
|
|
|
|
|
|
|
|
Biliary colic
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
1 / 163 (0.61%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatorenal syndrome
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperbilirubinaemia
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Liver disorder
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Investigations
|
|
|
|
|
|
|
|
|
|
|
Blood glucose decreased
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Body temperature fluctuation
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Catheterisation cardiac
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cortisol abnormal
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cortisol decreased
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
3 / 2321 (0.13%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Glycosylated haemoglobin increased
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
1 / 485 (0.21%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Paracentesis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Weight decreased
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
|
|
|
|
|
|
|
|
Abdominal wound dehiscence
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Accident at work
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Alcohol poisoning
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
1 / 1035 (0.10%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Animal bite
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
1 / 485 (0.21%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Carbon monoxide poisoning
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Clavicle fracture
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
1 / 485 (0.21%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Concussion
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Contusion
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Facial bones fracture
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fall
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fracture
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
2 / 4274 (0.05%) |
1 / 1374 (0.07%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
2 / 2321 (0.09%) |
1 / 163 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Greenstick fracture
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hand fracture
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Humerus fracture
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Joint dislocation
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
1 / 163 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Laceration
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Limb injury
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lower limb fracture
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Meniscus injury
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Open fracture
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural complication
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
1 / 1035 (0.10%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural haemorrhage
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Radius fracture
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Road traffic accident
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Shunt malfunction
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Stab wound
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subdural haematoma
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
1 / 290 (0.34%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tendon rupture
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thermal burn
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
|
|
|
|
|
|
|
|
Arnold-Chiari malformation
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bicuspid aortic valve
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Choanal atresia
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Congenital foot malformation
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cryptorchism
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Developmental glaucoma
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
1 / 1374 (0.07%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gonadal dysgenesis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
1 / 1374 (0.07%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hamartoma
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hydrocele
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Interruption of aortic arch
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pectus excavatum
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Phimosis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tibial torsion
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Type V hyperlipidaemia
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
|
|
|
|
|
|
|
|
Arrhythmia
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
6 / 2321 (0.26%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrial fibrillation
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac failure
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 9996 (0.02%) |
1 / 4274 (0.02%) |
1 / 1374 (0.07%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
5 / 2321 (0.22%) |
1 / 163 (0.61%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
Cardiac failure congestive
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
1 / 1374 (0.07%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardio-respiratory arrest
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiogenic shock
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myocardial ischaemia
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
1 / 1374 (0.07%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
2 / 2321 (0.09%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myocarditis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Supraventricular extrasystoles
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
1 / 1374 (0.07%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
1 / 1374 (0.07%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
|
|
|
|
|
|
|
|
Altered state of consciousness
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aphasia
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ataxia
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Brain oedema
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
1 / 290 (0.34%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Brain stem infarction
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Carpal tunnel syndrome
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
3 / 2321 (0.13%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
3 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral cyst
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral disorder
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
1 / 1035 (0.10%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral haemorrhage
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
1 / 290 (0.34%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral infarction
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
2 / 2321 (0.09%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral venous thrombosis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
1 / 290 (0.34%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebrospinal fluid leakage
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebrovascular accident
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
4 / 2321 (0.17%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Convulsion
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
1 / 1374 (0.07%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Depressed level of consciousness
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
1 / 290 (0.34%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
5 / 9996 (0.05%) |
2 / 4274 (0.05%) |
1 / 1374 (0.07%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
1 / 154 (0.65%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Facial paralysis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
1 / 1374 (0.07%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Facial paresis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Febrile convulsion
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 9996 (0.02%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Generalised tonic-clonic seizure
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 9996 (0.02%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Headache
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
8 / 9996 (0.08%) |
2 / 4274 (0.05%) |
0 / 1374 (0.00%) |
1 / 290 (0.34%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
7 / 8 |
2 / 2 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypoglycaemic seizure
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 9996 (0.02%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypotonia
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
1 / 1035 (0.10%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Idiopathic intracranial hypertension
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intracranial pressure increased
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
4 / 9996 (0.04%) |
2 / 4274 (0.05%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
4 / 5 |
2 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic stroke
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
2 / 2321 (0.09%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Loss of consciousness
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
2 / 2321 (0.09%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Migraine
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Multiple sclerosis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Optic neuritis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Paraesthesia
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Partial seizures
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 9996 (0.02%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Petit mal epilepsy
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
1 / 1374 (0.07%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Presyncope
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sciatica
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Seizure
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
12 / 9996 (0.12%) |
3 / 4274 (0.07%) |
2 / 1374 (0.15%) |
1 / 290 (0.34%) |
1 / 485 (0.21%) |
0 / 154 (0.00%) |
2 / 132 (1.52%) |
1 / 1035 (0.10%) |
5 / 2321 (0.22%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 23 |
0 / 3 |
1 / 2 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 2 |
0 / 1 |
2 / 7 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Syncope
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
2 / 4274 (0.05%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
5 / 2321 (0.22%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Temporal lobe epilepsy
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
1 / 290 (0.34%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
2 / 2321 (0.09%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Transverse sinus thrombosis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
1 / 290 (0.34%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
|
|
|
|
|
|
|
|
Bone marrow failure
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
1 / 1035 (0.10%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Immune thrombocytopenic purpura
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Iron deficiency anaemia
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lymphadenopathy
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sickle cell anaemia with crisis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Splenic haematoma
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
|
|
|
|
|
|
|
|
Deafness neurosensory
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
1 / 1374 (0.07%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Middle ear disorder
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Otorrhoea
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vertigo
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
|
|
|
|
|
|
|
|
Macular degeneration
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Maculopathy
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
1 / 1374 (0.07%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ocular hyperaemia
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Retinal detachment
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Strabismus
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Visual impairment
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
1 / 1035 (0.10%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
|
|
|
|
|
|
|
|
Abdominal distension
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain lower
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anal prolapse
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
1 / 163 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coeliac disease
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
1 / 1374 (0.07%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colitis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Constipation
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
2 / 163 (1.23%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Duodenal ulcer perforation
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastric ulcer haemorrhage
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastritis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Giant cell epulis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
1 / 154 (0.65%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ileus
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
2 / 163 (1.23%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Inflammatory bowel disease
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 9996 (0.02%) |
0 / 4274 (0.00%) |
1 / 1374 (0.07%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Large intestine perforation
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
1 / 163 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nausea
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
1 / 290 (0.34%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis acute
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Stomatitis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vomiting
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
5 / 9996 (0.05%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
2 / 2321 (0.09%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 5 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
|
|
|
|
|
|
|
|
Erythema
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Night sweats
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pruritus
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rash generalised
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
1 / 290 (0.34%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin striae
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Swelling face
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
|
|
|
|
|
|
|
|
Glycosuria
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nephropathy
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prerenal failure
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal failure
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
1 / 290 (0.34%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
1 / 1035 (0.10%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal impairment
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
1 / 1035 (0.10%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urethral stenosis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
|
|
|
|
|
|
|
|
Adrenocortical insufficiency acute
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
1 / 290 (0.34%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
3 / 2321 (0.13%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Autoimmune thyroiditis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
2 / 4274 (0.05%) |
2 / 1374 (0.15%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Glucocorticoid deficiency
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypothyroidism
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
4 / 9996 (0.04%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
4 / 4 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pituitary haemorrhage
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thyroid mass
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
2 / 1035 (0.19%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
|
|
|
|
|
|
|
|
Arthralgia
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
3 / 9996 (0.03%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
1 / 132 (0.76%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
3 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis reactive
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bone pain
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chondromalacia
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
1 / 163 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Collagen disorder
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Epiphysiolysis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
3 / 9996 (0.03%) |
3 / 4274 (0.07%) |
2 / 1374 (0.15%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
2 / 3 |
3 / 3 |
2 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Exostosis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fibromyalgia
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
4 / 2321 (0.17%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Joint instability
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
1 / 163 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Kyphoscoliosis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar spinal stenosis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Muscle tightness
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal stiffness
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
1 / 485 (0.21%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myalgia
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
1 / 163 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteochondrosis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
4 / 9996 (0.04%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
2 / 485 (0.41%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
3 / 4 |
0 / 0 |
0 / 0 |
0 / 0 |
2 / 4 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteonecrosis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
1 / 485 (0.21%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Psoriatic arthropathy
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Scoliosis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
4 / 9996 (0.04%) |
1 / 4274 (0.02%) |
1 / 1374 (0.07%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
1 / 154 (0.65%) |
5 / 132 (3.79%) |
1 / 1035 (0.10%) |
2 / 2321 (0.09%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
4 / 4 |
0 / 1 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
1 / 5 |
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal column stenosis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
|
|
|
|
|
|
|
|
Appendicitis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
1 / 1374 (0.07%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cellulitis orbital
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic sinusitis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic tonsillitis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
1 / 1374 (0.07%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dermo-hypodermitis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Encephalitis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Endocarditis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
4 / 9996 (0.04%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
3 / 2321 (0.13%) |
1 / 163 (0.61%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis norovirus
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
1 / 290 (0.34%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis rotavirus
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis viral
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal infection
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhagic fever with renal syndrome
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis C
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Herpes zoster infection neurological
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Herpes zoster meningitis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infection
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 9996 (0.02%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Influenza
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mastoiditis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
1 / 485 (0.21%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Meningitis pneumococcal
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
1 / 485 (0.21%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Orchitis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteomyelitis chronic
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
1 / 1374 (0.07%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Otitis media
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 9996 (0.02%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peritonitis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
1 / 4274 (0.02%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pilonidal cyst
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
1 / 1374 (0.07%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
7 / 9996 (0.07%) |
1 / 4274 (0.02%) |
2 / 1374 (0.15%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
2 / 2321 (0.09%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 1 |
0 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia influenzal
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
2 / 2321 (0.09%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory syncytial virus bronchitis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rhinitis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sepsis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
1 / 1035 (0.10%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Sinusitis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tonsillitis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tracheobronchitis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Viral upper respiratory tract infection
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 9996 (0.02%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
|
|
|
|
|
|
|
|
Decreased appetite
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 9996 (0.02%) |
0 / 4274 (0.00%) |
1 / 1374 (0.07%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dehydration
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetes mellitus
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
1 / 1035 (0.10%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic ketoacidosis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
1 / 1374 (0.07%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
2 / 1035 (0.19%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperlipidaemia
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypernatraemia
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 9996 (0.02%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
1 / 2321 (0.04%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lack of satiety
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 9996 (0.01%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metabolic alkalosis
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
1 / 1035 (0.10%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Type 1 diabetes mellitus
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
4 / 9996 (0.04%) |
1 / 4274 (0.02%) |
1 / 1374 (0.07%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
1 / 132 (0.76%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 1 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Type 2 diabetes mellitus
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 9996 (0.02%) |
3 / 4274 (0.07%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
1 / 132 (0.76%) |
0 / 1035 (0.00%) |
3 / 2321 (0.13%) |
1 / 163 (0.61%) |
occurrences causally related to treatment / all
|
1 / 2 |
2 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
2 / 3 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vitamin B12 deficiency
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
0 / 2321 (0.00%) |
1 / 163 (0.61%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vitamin D deficiency
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 9996 (0.00%) |
0 / 4274 (0.00%) |
0 / 1374 (0.00%) |
0 / 290 (0.00%) |
0 / 485 (0.00%) |
0 / 154 (0.00%) |
0 / 132 (0.00%) |
0 / 1035 (0.00%) |
2 / 2321 (0.09%) |
0 / 163 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |