Serious adverse events
|
DB: Zoledronic Acid |
DB: Denosumab |
OL: Zoledronic Acid / Denosumab |
OL: Denosumab / Denosumab |
Total subjects affected by serious adverse events
|
|
|
|
|
subjects affected / exposed
|
447 / 852 (52.46%) |
434 / 850 (51.06%) |
159 / 418 (38.04%) |
156 / 426 (36.62%) |
number of deaths (all causes)
|
169 |
154 |
49 |
48 |
number of deaths resulting from adverse events
|
|
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
|
Acute myeloid leukaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Adenocarcinoma of colon
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
2 / 850 (0.24%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Adenocarcinoma pancreas
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Basal cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
1 / 850 (0.12%) |
3 / 418 (0.72%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Basosquamous carcinoma of skin
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder cancer
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder cancer recurrent
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cervix carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic myelomonocytic leukaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colon cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
3 / 850 (0.35%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 3 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colorectal cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Diffuse large B-cell lymphoma
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Endometrial adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatocellular carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malignant melanoma
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malignant neoplasm of pleura
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malignant neoplasm of renal pelvis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malignant pleural effusion
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Meningioma
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to spine
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Neoplasm of orbit
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neuroendocrine tumour
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Non-Hodgkin's lymphoma
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Non-small cell lung cancer stage I
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Paraproteinaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
3 / 850 (0.35%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
Plasma cell leukaemia
|
|
|
|
|
subjects affected / exposed
|
4 / 852 (0.47%) |
1 / 850 (0.12%) |
1 / 418 (0.24%) |
2 / 426 (0.47%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Plasma cell myeloma
|
|
|
|
|
subjects affected / exposed
|
16 / 852 (1.88%) |
18 / 850 (2.12%) |
3 / 418 (0.72%) |
10 / 426 (2.35%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 21 |
0 / 3 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 8 |
0 / 10 |
0 / 3 |
0 / 9 |
Plasma cell myeloma recurrent
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Plasmacytoma
|
|
|
|
|
subjects affected / exposed
|
4 / 852 (0.47%) |
7 / 850 (0.82%) |
1 / 418 (0.24%) |
5 / 426 (1.17%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 8 |
0 / 1 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
Prostate cancer
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
3 / 850 (0.35%) |
1 / 418 (0.24%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sarcoma
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma of lung
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma of skin
|
|
|
|
|
subjects affected / exposed
|
3 / 852 (0.35%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute leukaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
2 / 426 (0.47%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
Acute lymphocytic leukaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute lymphocytic leukaemia recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Adenocarcinoma gastric
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anaplastic large-cell lymphoma
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bone marrow tumour cell infiltration
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Breast cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Clear cell renal cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Glioblastoma multiforme
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intraductal proliferative breast lesion
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malignant neoplasm progression
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to bone
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Myelodysplastic syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oropharyngeal cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prostate cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Spinal cord neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tumour pain
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
|
|
Aortic aneurysm
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic aneurysm rupture
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic dissection
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic dissection rupture
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Circulatory collapse
|
|
|
|
|
subjects affected / exposed
|
4 / 852 (0.47%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 0 |
0 / 0 |
Deep vein thrombosis
|
|
|
|
|
subjects affected / exposed
|
8 / 852 (0.94%) |
11 / 850 (1.29%) |
2 / 418 (0.48%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
1 / 9 |
0 / 11 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Essential hypertension
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haematoma
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypertension
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
4 / 850 (0.47%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypotension
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
2 / 850 (0.24%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypovolaemic shock
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Orthostatic hypotension
|
|
|
|
|
subjects affected / exposed
|
3 / 852 (0.35%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral arterial occlusive disease
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery aneurysm
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral ischaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
2 / 418 (0.48%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Superior vena cava syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thrombophlebitis superficial
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vasospasm
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arterial disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive urgency
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Venous thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
|
|
Cataract operation
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fistula repair
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haematopoietic stem cell mobilisation
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Internal fixation of fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intra-uterine contraceptive device removal
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Knee arthroplasty
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rehabilitation therapy
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Autologous haematopoietic stem cell transplant
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
|
|
Asthenia
|
|
|
|
|
subjects affected / exposed
|
7 / 852 (0.82%) |
3 / 850 (0.35%) |
1 / 418 (0.24%) |
5 / 426 (1.17%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chest pain
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chills
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Death
|
|
|
|
|
subjects affected / exposed
|
3 / 852 (0.35%) |
3 / 850 (0.35%) |
1 / 418 (0.24%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 1 |
0 / 1 |
Disease progression
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Fatigue
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
2 / 418 (0.48%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gait disturbance
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
General physical health deterioration
|
|
|
|
|
subjects affected / exposed
|
10 / 852 (1.17%) |
10 / 850 (1.18%) |
2 / 418 (0.48%) |
6 / 426 (1.41%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 15 |
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 6 |
0 / 1 |
0 / 1 |
Generalised oedema
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
3 / 850 (0.35%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperpyrexia
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperthermia
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Localised oedema
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malaise
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mucosal ulceration
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Multiple organ dysfunction syndrome
|
|
|
|
|
subjects affected / exposed
|
6 / 852 (0.70%) |
5 / 850 (0.59%) |
3 / 418 (0.72%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 6 |
0 / 5 |
0 / 3 |
0 / 1 |
Non-cardiac chest pain
|
|
|
|
|
subjects affected / exposed
|
5 / 852 (0.59%) |
4 / 850 (0.47%) |
0 / 418 (0.00%) |
2 / 426 (0.47%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
|
|
subjects affected / exposed
|
3 / 852 (0.35%) |
5 / 850 (0.59%) |
2 / 418 (0.48%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 5 |
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Performance status decreased
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
|
|
subjects affected / exposed
|
28 / 852 (3.29%) |
24 / 850 (2.82%) |
2 / 418 (0.48%) |
4 / 426 (0.94%) |
occurrences causally related to treatment / all
|
5 / 32 |
0 / 37 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Sudden cardiac death
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Sudden death
|
|
|
|
|
subjects affected / exposed
|
5 / 852 (0.59%) |
3 / 850 (0.35%) |
1 / 418 (0.24%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 3 |
0 / 1 |
0 / 1 |
Oedema
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
2 / 426 (0.47%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Systemic inflammatory response syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
|
|
Acute graft versus host disease
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute graft versus host disease in intestine
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anaphylactic reaction
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypersensitivity
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Serum sickness
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
|
|
Adenomyosis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Benign prostatic hyperplasia
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Scrotal oedema
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Testicular mass
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
|
Acute pulmonary oedema
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Acute respiratory distress syndrome
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute respiratory failure
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
2 / 850 (0.24%) |
2 / 418 (0.48%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aspiration
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Asthma
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchial obstruction
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchopneumopathy
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic obstructive pulmonary disease
|
|
|
|
|
subjects affected / exposed
|
4 / 852 (0.47%) |
4 / 850 (0.47%) |
3 / 418 (0.72%) |
3 / 426 (0.70%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cough
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
3 / 850 (0.35%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
|
|
subjects affected / exposed
|
10 / 852 (1.17%) |
5 / 850 (0.59%) |
2 / 418 (0.48%) |
2 / 426 (0.47%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 5 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypoxia
|
|
|
|
|
subjects affected / exposed
|
3 / 852 (0.35%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Interstitial lung disease
|
|
|
|
|
subjects affected / exposed
|
3 / 852 (0.35%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung disorder
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
3 / 850 (0.35%) |
1 / 418 (0.24%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nasal discomfort
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Non-cardiogenic pulmonary oedema
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
|
|
subjects affected / exposed
|
4 / 852 (0.47%) |
6 / 850 (0.71%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 9 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Pneumonia aspiration
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonitis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
6 / 850 (0.71%) |
2 / 418 (0.48%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 6 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumothorax
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Productive cough
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary artery thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
|
|
subjects affected / exposed
|
13 / 852 (1.53%) |
16 / 850 (1.88%) |
5 / 418 (1.20%) |
3 / 426 (0.70%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 16 |
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 1 |
0 / 1 |
Pulmonary fibrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary oedema
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
2 / 850 (0.24%) |
2 / 418 (0.48%) |
3 / 426 (0.70%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 3 |
Respiratory acidosis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory distress
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory failure
|
|
|
|
|
subjects affected / exposed
|
11 / 852 (1.29%) |
4 / 850 (0.47%) |
4 / 418 (0.96%) |
2 / 426 (0.47%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 4 |
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 2 |
0 / 2 |
Stridor
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Asphyxia
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchiectasis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dyspnoea exertional
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pleural disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pleural thickening
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pleuritic pain
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Pulmonary hypertension
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
|
|
Anxiety
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Completed suicide
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
Confusional state
|
|
|
|
|
subjects affected / exposed
|
3 / 852 (0.35%) |
5 / 850 (0.59%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Delirium
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
4 / 850 (0.47%) |
0 / 418 (0.00%) |
2 / 426 (0.47%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Depression
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
3 / 850 (0.35%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Disorientation
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Major depression
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mental status changes
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mutism
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Psychotic disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Suicide attempt
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Adjustment disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Drug dependence
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Organic brain syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Psychiatric decompensation
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Product issues
|
|
|
|
|
Device breakage
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device failure
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device occlusion
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device dislocation
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
|
|
Acute hepatic failure
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Bile duct stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholangitis acute
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
2 / 850 (0.24%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis acute
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
0 / 850 (0.00%) |
2 / 418 (0.48%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Drug-induced liver injury
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic function abnormal
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis toxic
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperbilirubinaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bile duct obstruction
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis chronic
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gallbladder rupture
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic failure
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatotoxicity
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Jaundice cholestatic
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Investigations
|
|
|
|
|
Alanine aminotransferase increased
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
3 / 850 (0.35%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aspartate aminotransferase increased
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
3 / 850 (0.35%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bilirubin conjugated increased
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood bilirubin increased
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood creatine increased
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood creatinine increased
|
|
|
|
|
subjects affected / exposed
|
3 / 852 (0.35%) |
2 / 850 (0.24%) |
1 / 418 (0.24%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
1 / 3 |
2 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood electrolytes abnormal
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood immunoglobulin G increased
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood immunoglobulin M increased
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood lactate dehydrogenase increased
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Body temperature increased
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bone marrow plasmacyte count increased
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
C-reactive protein increased
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chest X-ray abnormal
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Eastern Cooperative Oncology Group performance status worsened
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemoglobin decreased
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Heart rate irregular
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Light chain analysis increased
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Liver function test abnormal
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Monoclonal immunoglobulin present
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
2 / 850 (0.24%) |
1 / 418 (0.24%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Neutrophil count decreased
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Platelet count decreased
|
|
|
|
|
subjects affected / exposed
|
6 / 852 (0.70%) |
2 / 850 (0.24%) |
1 / 418 (0.24%) |
2 / 426 (0.47%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 2 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Weight decreased
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
White blood cell count decreased
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood immunoglobulin A increased
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Influenza A virus test positive
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Light chain analysis abnormal
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Plasma cells increased
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Plasma cells present
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Protein urine present
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
White blood cell count increased
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
|
|
Abdominal injury
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Anastomotic leak
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bone contusion
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Brain contusion
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Cervical vertebral fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Concussion
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Fall
|
|
|
|
|
subjects affected / exposed
|
6 / 852 (0.70%) |
3 / 850 (0.35%) |
0 / 418 (0.00%) |
3 / 426 (0.70%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Femoral neck fracture
|
|
|
|
|
subjects affected / exposed
|
7 / 852 (0.82%) |
2 / 850 (0.24%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fibula fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hand fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Head injury
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hip fracture
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
3 / 850 (0.35%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Humerus fracture
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Joint dislocation
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar vertebral fracture
|
|
|
|
|
subjects affected / exposed
|
8 / 852 (0.94%) |
4 / 850 (0.47%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Patella fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural haemorrhage
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Procedural pain
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
2 / 426 (0.47%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
3 / 426 (0.70%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sternal fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subdural haematoma
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Tendon rupture
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thoracic vertebral fracture
|
|
|
|
|
subjects affected / exposed
|
5 / 852 (0.59%) |
6 / 850 (0.71%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 7 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tibia fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Transfusion related complication
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ankle fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Compression fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Craniocerebral injury
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Facial bones fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Incarcerated incisional hernia
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infusion related reaction
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Injury
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Limb fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Poisoning
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
Post procedural fever
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Procedural nausea
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary contusion
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin laceration
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wound dehiscence
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
|
|
Aplasia
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Odontogenic cyst
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
|
|
Acute coronary syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
2 / 850 (0.24%) |
3 / 418 (0.72%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute myocardial infarction
|
|
|
|
|
subjects affected / exposed
|
6 / 852 (0.70%) |
2 / 850 (0.24%) |
1 / 418 (0.24%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 0 |
0 / 0 |
0 / 0 |
Angina pectoris
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
2 / 850 (0.24%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Angina unstable
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
2 / 418 (0.48%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrial fibrillation
|
|
|
|
|
subjects affected / exposed
|
10 / 852 (1.17%) |
4 / 850 (0.47%) |
2 / 418 (0.48%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 5 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrial flutter
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrial tachycardia
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
|
|
subjects affected / exposed
|
4 / 852 (0.47%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac amyloidosis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac arrest
|
|
|
|
|
subjects affected / exposed
|
11 / 852 (1.29%) |
6 / 850 (0.71%) |
1 / 418 (0.24%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 6 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 11 |
0 / 5 |
0 / 1 |
0 / 1 |
Cardiac disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac failure
|
|
|
|
|
subjects affected / exposed
|
7 / 852 (0.82%) |
11 / 850 (1.29%) |
3 / 418 (0.72%) |
4 / 426 (0.94%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 13 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 6 |
0 / 2 |
0 / 0 |
Cardiac failure acute
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 0 |
Cardiac failure chronic
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
3 / 850 (0.35%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
Cardiac failure congestive
|
|
|
|
|
subjects affected / exposed
|
5 / 852 (0.59%) |
5 / 850 (0.59%) |
1 / 418 (0.24%) |
3 / 426 (0.70%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Cardio-respiratory arrest
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
Cardiopulmonary failure
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiovascular insufficiency
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Coronary artery disease
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
Left ventricular failure
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Mitral valve stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myocardial infarction
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
2 / 426 (0.47%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
Myocardial ischaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Myocarditis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Palpitations
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pericarditis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sinus bradycardia
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sinus node dysfunction
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sinus tachycardia
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
3 / 850 (0.35%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tachyarrhythmia
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tricuspid valve incompetence
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute left ventricular failure
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Arrhythmia
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac tamponade
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac valve disease
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiomyopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Left ventricular dysfunction
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pericardial effusion
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular arrhythmia
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
|
|
Basilar migraine
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Brain injury
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cauda equina syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral haemorrhage
|
|
|
|
|
subjects affected / exposed
|
4 / 852 (0.47%) |
0 / 850 (0.00%) |
2 / 418 (0.48%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 1 |
Cerebral ischaemia
|
|
|
|
|
subjects affected / exposed
|
3 / 852 (0.35%) |
2 / 850 (0.24%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral vasoconstriction
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebrovascular accident
|
|
|
|
|
subjects affected / exposed
|
5 / 852 (0.59%) |
5 / 850 (0.59%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Cognitive disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coma
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Depressed level of consciousness
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dizziness
|
|
|
|
|
subjects affected / exposed
|
4 / 852 (0.47%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Encephalopathy
|
|
|
|
|
subjects affected / exposed
|
3 / 852 (0.35%) |
2 / 850 (0.24%) |
2 / 418 (0.48%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Generalised tonic-clonic seizure
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhage intracranial
|
|
|
|
|
subjects affected / exposed
|
3 / 852 (0.35%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhagic stroke
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hemiparesis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hemiplegia
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypoaesthesia
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic cerebral infarction
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic stroke
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
3 / 850 (0.35%) |
1 / 418 (0.24%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Lacunar infarction
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Loss of consciousness
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lumbosacral radiculopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nerve degeneration
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neuropathy peripheral
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Paralysis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Paraparesis
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Paraplegia
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Paresis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Polyneuropathy
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Presyncope
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Radiculopathy
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sciatica
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Seizure
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
3 / 850 (0.35%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Seizure like phenomena
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal cord compression
|
|
|
|
|
subjects affected / exposed
|
8 / 852 (0.94%) |
4 / 850 (0.47%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subarachnoid haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Syncope
|
|
|
|
|
subjects affected / exposed
|
9 / 852 (1.06%) |
7 / 850 (0.82%) |
0 / 418 (0.00%) |
2 / 426 (0.47%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 7 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Brain oedema
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral atrophy
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral haematoma
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral infarction
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebrovascular disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cervical cord compression
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dementia
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Encephalitis post varicella
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Headache
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intracranial mass
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Myelopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Parkinson's disease
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
|
|
Agranulocytosis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anaemia
|
|
|
|
|
subjects affected / exposed
|
26 / 852 (3.05%) |
12 / 850 (1.41%) |
5 / 418 (1.20%) |
8 / 426 (1.88%) |
occurrences causally related to treatment / all
|
1 / 33 |
0 / 17 |
0 / 6 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Autoimmune haemolytic anaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bicytopenia
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bone marrow failure
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Febrile neutropenia
|
|
|
|
|
subjects affected / exposed
|
25 / 852 (2.93%) |
23 / 850 (2.71%) |
7 / 418 (1.67%) |
6 / 426 (1.41%) |
occurrences causally related to treatment / all
|
0 / 29 |
0 / 25 |
0 / 9 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Haemolytic anaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperviscosity syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
3 / 850 (0.35%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
Leukocytosis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Leukopenia
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
2 / 850 (0.24%) |
2 / 418 (0.48%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neutropenia
|
|
|
|
|
subjects affected / exposed
|
13 / 852 (1.53%) |
4 / 850 (0.47%) |
4 / 418 (0.96%) |
3 / 426 (0.70%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 4 |
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
|
|
subjects affected / exposed
|
4 / 852 (0.47%) |
2 / 850 (0.24%) |
3 / 418 (0.72%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
Thrombocytopenia
|
|
|
|
|
subjects affected / exposed
|
12 / 852 (1.41%) |
9 / 850 (1.06%) |
2 / 418 (0.48%) |
7 / 426 (1.64%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 9 |
0 / 3 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acquired haemophilia with anti FVIII, XI, or XIII
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anaemia of malignant disease
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cytopenia
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Platelet disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thrombocytosis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
|
|
Vertigo
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vertigo positional
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
|
|
Cataract
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
0 / 850 (0.00%) |
2 / 418 (0.48%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diplopia
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Exophthalmos
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Extraocular muscle paresis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ulcerative keratitis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vision blurred
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
|
|
Abdominal discomfort
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal distension
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal hernia
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal incarcerated hernia
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
|
|
subjects affected / exposed
|
5 / 852 (0.59%) |
1 / 850 (0.12%) |
4 / 418 (0.96%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain lower
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal wall haematoma
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic gastritis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colitis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
2 / 850 (0.24%) |
1 / 418 (0.24%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colitis ischaemic
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Constipation
|
|
|
|
|
subjects affected / exposed
|
4 / 852 (0.47%) |
3 / 850 (0.35%) |
2 / 418 (0.48%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
|
|
subjects affected / exposed
|
10 / 852 (1.17%) |
9 / 850 (1.06%) |
1 / 418 (0.24%) |
4 / 426 (0.94%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 10 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diarrhoea haemorrhagic
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulum intestinal
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Duodenal ulcer
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Duodenal ulcer haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dysphagia
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
3 / 850 (0.35%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Enteritis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastritis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastritis erosive
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal amyloidosis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
5 / 852 (0.59%) |
3 / 850 (0.35%) |
1 / 418 (0.24%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal perforation
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
Gingivitis ulcerative
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hiatus hernia
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ileus
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
2 / 418 (0.48%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
2 / 850 (0.24%) |
1 / 418 (0.24%) |
3 / 426 (0.70%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal obstruction
|
|
|
|
|
subjects affected / exposed
|
3 / 852 (0.35%) |
1 / 850 (0.12%) |
2 / 418 (0.48%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Large intestinal obstruction
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Large intestine perforation
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Large intestine polyp
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lower gastrointestinal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
2 / 426 (0.47%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mechanical ileus
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Melaena
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mouth haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nausea
|
|
|
|
|
subjects affected / exposed
|
4 / 852 (0.47%) |
4 / 850 (0.47%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oesophagitis
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Proctitis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
4 / 850 (0.47%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
Stomatitis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subileus
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Umbilical hernia
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vomiting
|
|
|
|
|
subjects affected / exposed
|
11 / 852 (1.29%) |
7 / 850 (0.82%) |
3 / 418 (0.72%) |
3 / 426 (0.70%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 7 |
1 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anal fissure
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Appendiceal mucocoele
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Crohn's disease
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dyspepsia
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastric ulcer haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal pain
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrooesophageal reflux disease
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gingival bleeding
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal ischaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Jejunal perforation
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Large intestinal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Obstructive pancreatitis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Retroperitoneal mass
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Small intestinal perforation
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Toothache
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
|
|
Drug eruption
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Erythema multiforme
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperhidrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Keloid scar
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Purpura
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rash
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rash macular
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rash maculo-papular
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urticaria
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Angioedema
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Decubitus ulcer
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rash generalised
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin ulcer
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
|
|
Acute kidney injury
|
|
|
|
|
subjects affected / exposed
|
24 / 852 (2.82%) |
17 / 850 (2.00%) |
8 / 418 (1.91%) |
2 / 426 (0.47%) |
occurrences causally related to treatment / all
|
5 / 27 |
2 / 18 |
0 / 9 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 0 |
Bladder perforation
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic kidney disease
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cystitis haemorrhagic
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dysuria
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haematuria
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal colic
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
2 / 850 (0.24%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal failure
|
|
|
|
|
subjects affected / exposed
|
7 / 852 (0.82%) |
4 / 850 (0.47%) |
1 / 418 (0.24%) |
6 / 426 (1.41%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 4 |
0 / 1 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Renal impairment
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
2 / 850 (0.24%) |
1 / 418 (0.24%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ureteric obstruction
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ureterolithiasis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary retention
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
2 / 850 (0.24%) |
2 / 418 (0.48%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 2 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder obstruction
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nephropathy toxic
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oliguria
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
|
|
Adrenal insufficiency
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypercalcaemia of malignancy
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperparathyroidism primary
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Steroid withdrawal syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Adrenocortical insufficiency acute
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperthyroidism
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
|
|
Arthralgia
|
|
|
|
|
subjects affected / exposed
|
5 / 852 (0.59%) |
3 / 850 (0.35%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Back pain
|
|
|
|
|
subjects affected / exposed
|
16 / 852 (1.88%) |
9 / 850 (1.06%) |
1 / 418 (0.24%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 13 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bone pain
|
|
|
|
|
subjects affected / exposed
|
7 / 852 (0.82%) |
1 / 850 (0.12%) |
3 / 418 (0.72%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 1 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Flank pain
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Joint effusion
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar spinal stenosis
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Muscular weakness
|
|
|
|
|
subjects affected / exposed
|
3 / 852 (0.35%) |
3 / 850 (0.35%) |
1 / 418 (0.24%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 3 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Musculoskeletal chest pain
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal discomfort
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal pain
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myalgia
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neck pain
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteonecrosis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteonecrosis of jaw
|
|
|
|
|
subjects affected / exposed
|
13 / 852 (1.53%) |
18 / 850 (2.12%) |
11 / 418 (2.63%) |
12 / 426 (2.82%) |
occurrences causally related to treatment / all
|
13 / 14 |
18 / 18 |
10 / 11 |
12 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
|
|
subjects affected / exposed
|
5 / 852 (0.59%) |
3 / 850 (0.35%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pathological fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
2 / 850 (0.24%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal osteoarthritis
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal pain
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
1 / 418 (0.24%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spondylolisthesis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tendonitis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vertebral lesion
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bone lesion
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bone swelling
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Costochondritis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral disc disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mobility decreased
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteolysis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Periarthritis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
|
|
Abscess bacterial
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Adenoviral haemorrhagic cystitis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
|
|
subjects affected / exposed
|
3 / 852 (0.35%) |
2 / 850 (0.24%) |
1 / 418 (0.24%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis bacterial
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis infective
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atypical pneumonia
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Bacteraemia
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
1 / 850 (0.12%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bacterial infection
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
3 / 850 (0.35%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bacterial pyelonephritis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bacterial sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchiolitis
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
|
|
subjects affected / exposed
|
7 / 852 (0.82%) |
11 / 850 (1.29%) |
4 / 418 (0.96%) |
2 / 426 (0.47%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 11 |
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Bursitis infective
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
|
|
subjects affected / exposed
|
5 / 852 (0.59%) |
4 / 850 (0.47%) |
0 / 418 (0.00%) |
4 / 426 (0.94%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
0 / 0 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cellulitis orbital
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis infective
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic sinusitis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium bacteraemia
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium difficile colitis
|
|
|
|
|
subjects affected / exposed
|
4 / 852 (0.47%) |
6 / 850 (0.71%) |
1 / 418 (0.24%) |
2 / 426 (0.47%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium difficile infection
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
3 / 850 (0.35%) |
1 / 418 (0.24%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Creutzfeldt-Jakob disease
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Cystitis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cytomegalovirus chorioretinitis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cytomegalovirus infection
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device related infection
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
3 / 850 (0.35%) |
1 / 418 (0.24%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diarrhoea infectious
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
3 / 850 (0.35%) |
1 / 418 (0.24%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Encephalitis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Escherichia sepsis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Escherichia urinary tract infection
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Extradural abscess
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Febrile infection
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Folliculitis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
|
|
subjects affected / exposed
|
3 / 852 (0.35%) |
1 / 850 (0.12%) |
1 / 418 (0.24%) |
2 / 426 (0.47%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis viral
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gingivitis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Herpes zoster
|
|
|
|
|
subjects affected / exposed
|
9 / 852 (1.06%) |
5 / 850 (0.59%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 6 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Human herpesvirus 6 infection
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infection
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
3 / 850 (0.35%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Infection in an immunocompromised host
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infection reactivation
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infective exacerbation of chronic obstructive airways disease
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Influenza
|
|
|
|
|
subjects affected / exposed
|
6 / 852 (0.70%) |
10 / 850 (1.18%) |
3 / 418 (0.72%) |
5 / 426 (1.17%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 10 |
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Intervertebral discitis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lower respiratory tract infection
|
|
|
|
|
subjects affected / exposed
|
12 / 852 (1.41%) |
5 / 850 (0.59%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 5 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Lower respiratory tract infection fungal
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lower respiratory tract infection viral
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung infection
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
2 / 850 (0.24%) |
2 / 418 (0.48%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Meningitis meningococcal
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Meningitis pneumococcal
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Necrotising fasciitis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neutropenic infection
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neutropenic sepsis
|
|
|
|
|
subjects affected / exposed
|
3 / 852 (0.35%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
3 / 850 (0.35%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 3 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Otitis media
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Parainfluenzae virus infection
|
|
|
|
|
subjects affected / exposed
|
3 / 852 (0.35%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Perineal abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Periodontitis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peritonitis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
2 / 850 (0.24%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Peritonsillar abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumococcal sepsis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumocystis jirovecii infection
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumocystis jirovecii pneumonia
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
|
|
subjects affected / exposed
|
82 / 852 (9.62%) |
79 / 850 (9.29%) |
34 / 418 (8.13%) |
31 / 426 (7.28%) |
occurrences causally related to treatment / all
|
0 / 114 |
2 / 95 |
1 / 45 |
0 / 46 |
deaths causally related to treatment / all
|
0 / 11 |
0 / 6 |
0 / 3 |
0 / 8 |
Pneumonia bacterial
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia klebsiella
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia legionella
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia pneumococcal
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia respiratory syncytial viral
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia staphylococcal
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia viral
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
1 / 418 (0.24%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural infection
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative wound infection
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pseudomonal sepsis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary mycosis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
|
|
subjects affected / exposed
|
8 / 852 (0.94%) |
7 / 850 (0.82%) |
8 / 418 (1.91%) |
5 / 426 (1.17%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 8 |
0 / 8 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Respiratory tract infection fungal
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory tract infection viral
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Salmonellosis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Scrotal abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sepsis
|
|
|
|
|
subjects affected / exposed
|
24 / 852 (2.82%) |
19 / 850 (2.24%) |
8 / 418 (1.91%) |
11 / 426 (2.58%) |
occurrences causally related to treatment / all
|
1 / 31 |
0 / 21 |
0 / 9 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 9 |
0 / 2 |
0 / 3 |
0 / 3 |
Sepsis syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Septic necrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Septic shock
|
|
|
|
|
subjects affected / exposed
|
7 / 852 (0.82%) |
6 / 850 (0.71%) |
7 / 418 (1.67%) |
2 / 426 (0.47%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 8 |
0 / 9 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 4 |
0 / 0 |
Sinusitis
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal cord infection
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal bacteraemia
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal sepsis
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal skin infection
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tonsillitis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tracheobronchitis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Upper respiratory tract infection
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
7 / 850 (0.82%) |
2 / 418 (0.48%) |
2 / 426 (0.47%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 7 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
|
|
subjects affected / exposed
|
9 / 852 (1.06%) |
6 / 850 (0.71%) |
2 / 418 (0.48%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 10 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract infection bacterial
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
3 / 850 (0.35%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Varicella
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Viral infection
|
|
|
|
|
subjects affected / exposed
|
3 / 852 (0.35%) |
2 / 850 (0.24%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Viral myositis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wound infection
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abscess jaw
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abscess neck
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abscess soft tissue
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
2 / 418 (0.48%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute sinusitis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bacterial parotitis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchopulmonary aspergillosis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
2 / 418 (0.48%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Campylobacter gastroenteritis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Candida infection
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device related sepsis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Empyema
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Endocarditis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Enterocolitis bacterial
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Epiglottitis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gangrene
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis norovirus
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis salmonella
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal infection
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis B
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Herpes virus infection
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Herpes zoster cutaneous disseminated
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infected dermal cyst
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Large intestine infection
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Meningitis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Meningitis cryptococcal
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metapneumovirus infection
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nasopharyngitis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Opportunistic infection
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Otitis externa
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Parvovirus B19 infection
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pleural infection
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia fungal
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Pneumonia haemophilus
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia pseudomonal
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia streptococcal
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pseudomembranous colitis
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Pulmonary sepsis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Soft tissue infection
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract infection fungal
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular device infection
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Viral upper respiratory tract infection
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
|
|
Cachexia
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Decreased appetite
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dehydration
|
|
|
|
|
subjects affected / exposed
|
12 / 852 (1.41%) |
10 / 850 (1.18%) |
3 / 418 (0.72%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 12 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Electrolyte imbalance
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Failure to thrive
|
|
|
|
|
subjects affected / exposed
|
3 / 852 (0.35%) |
1 / 850 (0.12%) |
1 / 418 (0.24%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 1 |
Fluid imbalance
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gout
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemosiderosis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypercalcaemia
|
|
|
|
|
subjects affected / exposed
|
8 / 852 (0.94%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
3 / 426 (0.70%) |
occurrences causally related to treatment / all
|
1 / 9 |
0 / 2 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
3 / 850 (0.35%) |
1 / 418 (0.24%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
2 / 850 (0.24%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypernatraemia
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperproteinaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperuricaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypocalcaemia
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
8 / 850 (0.94%) |
2 / 418 (0.48%) |
2 / 426 (0.47%) |
occurrences causally related to treatment / all
|
1 / 2 |
7 / 8 |
1 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
|
|
subjects affected / exposed
|
2 / 852 (0.23%) |
3 / 850 (0.35%) |
1 / 418 (0.24%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
|
|
subjects affected / exposed
|
7 / 852 (0.82%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
2 / 426 (0.47%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
|
|
subjects affected / exposed
|
3 / 852 (0.35%) |
3 / 850 (0.35%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lactic acidosis
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tumour lysis syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 852 (0.12%) |
0 / 850 (0.00%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperglycaemic hyperosmolar nonketotic syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypomagnesaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypophosphataemia
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
0 / 850 (0.00%) |
1 / 418 (0.24%) |
1 / 426 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Obesity
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Steroid diabetes
|
|
|
|
|
subjects affected / exposed
|
0 / 852 (0.00%) |
1 / 850 (0.12%) |
0 / 418 (0.00%) |
0 / 426 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |