Serious adverse events
|
DB: Placebo |
DB: Denosumab |
OLE: Placebo/ Denosumab |
OLE: Denosumab/ Denosumab |
Total subjects affected by serious adverse events
|
|
|
|
|
subjects affected / exposed
|
332 / 705 (47.09%) |
341 / 720 (47.36%) |
39 / 109 (35.78%) |
36 / 101 (35.64%) |
number of deaths (all causes)
|
326 |
352 |
23 |
15 |
number of deaths resulting from adverse events
|
|
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
|
Adenocarcinoma of colon
|
|
|
|
|
subjects affected / exposed
|
2 / 705 (0.28%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Basal cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 / 705 (0.28%) |
7 / 720 (0.97%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 8 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder cancer recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Choroid melanoma
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
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 |
Colon cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Colon cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
1 / 109 (0.92%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Colorectal cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastric cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 stromal tumour
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 tract adenoma
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 benign neoplasm
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Laryngeal cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lip squamous cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lipoma
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung neoplasm malignant
|
|
|
|
|
subjects affected / exposed
|
2 / 705 (0.28%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Malignant melanoma
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mantle cell lymphoma
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Meningioma
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 abdominal cavity
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
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 |
Metastases to bladder
|
|
|
|
|
subjects affected / exposed
|
2 / 705 (0.28%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Metastases to bone
|
|
|
|
|
subjects affected / exposed
|
5 / 705 (0.71%) |
10 / 720 (1.39%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 10 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 0 |
0 / 0 |
Metastases to central nervous system
|
|
|
|
|
subjects affected / exposed
|
2 / 705 (0.28%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (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 / 1 |
0 / 0 |
0 / 0 |
Metastases to larynx
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to liver
|
|
|
|
|
subjects affected / exposed
|
4 / 705 (0.57%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 0 |
Metastases to lung
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Metastases to lymph nodes
|
|
|
|
|
subjects affected / exposed
|
6 / 705 (0.85%) |
6 / 720 (0.83%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 0 |
0 / 0 |
Metastases to peritoneum
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to skin
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to small intestine
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to soft tissue
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastasis
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
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 |
Metastatic malignant melanoma
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
0 / 720 (0.00%) |
1 / 109 (0.92%) |
0 / 101 (0.00%) |
occurrences 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 |
Metastatic pain
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Metastatic squamous cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myeloproliferative disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Neoplasm prostate
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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-Hodgkin's lymphoma
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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-small cell lung cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
0 / 720 (0.00%) |
1 / 109 (0.92%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatic carcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Pancreatic neoplasm
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Papillary thyroid cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Papilloma
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Plasma cell myeloma
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prostate cancer
|
|
|
|
|
subjects affected / exposed
|
21 / 705 (2.98%) |
15 / 720 (2.08%) |
1 / 109 (0.92%) |
1 / 101 (0.99%) |
occurrences causally related to treatment / all
|
0 / 27 |
0 / 16 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 11 |
0 / 8 |
0 / 0 |
0 / 1 |
Prostate cancer metastatic
|
|
|
|
|
subjects affected / exposed
|
6 / 705 (0.85%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
Prostate cancer recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
1 / 109 (0.92%) |
0 / 101 (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 |
Rectal adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
2 / 705 (0.28%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Rectal cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectosigmoid cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Renal cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
0 / 720 (0.00%) |
1 / 109 (0.92%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Small cell lung cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Small intestine carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tumour haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
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
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic dilatation
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arterial thrombosis
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Deep vein thrombosis
|
|
|
|
|
subjects affected / exposed
|
6 / 705 (0.85%) |
8 / 720 (1.11%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
occurrences causally related to treatment / all
|
0 / 6 |
2 / 8 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Embolism
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
0 / 720 (0.00%) |
1 / 109 (0.92%) |
0 / 101 (0.00%) |
occurrences 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 |
Haematoma
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
3 / 720 (0.42%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Hypertension
|
|
|
|
|
subjects affected / exposed
|
3 / 705 (0.43%) |
3 / 720 (0.42%) |
0 / 109 (0.00%) |
3 / 101 (2.97%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive crisis
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypotension
|
|
|
|
|
subjects affected / exposed
|
4 / 705 (0.57%) |
5 / 720 (0.69%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intermittent claudication
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
3 / 720 (0.42%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Ischaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lymphoedema
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Orthostatic hypotension
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Pelvic venous thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 arterial occlusive disease
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral ischaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Phlebitis
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Shock
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Superior vena cava syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thrombophlebitis
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Thrombosis
|
|
|
|
|
subjects affected / exposed
|
3 / 705 (0.43%) |
1 / 720 (0.14%) |
1 / 109 (0.92%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular occlusion
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vasculitis
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Venous thrombosis
|
|
|
|
|
subjects affected / exposed
|
2 / 705 (0.28%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Venous thrombosis limb
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
|
|
Bladder catheterisation
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cancer surgery
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardioversion
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cataract operation
|
|
|
|
|
subjects affected / exposed
|
2 / 705 (0.28%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Colostomy
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cystostomy
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Debridement
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Finger amputation
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Heart valve operation
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hip arthroplasty
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal hernia repair
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Knee arthroplasty
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Orchidectomy
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin graft
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Stent placement
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Transurethral prostatectomy
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (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 disorders and administration site conditions
|
|
|
|
|
Asthenia
|
|
|
|
|
subjects affected / exposed
|
10 / 705 (1.42%) |
9 / 720 (1.25%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 10 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chest pain
|
|
|
|
|
subjects affected / exposed
|
3 / 705 (0.43%) |
4 / 720 (0.56%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chills
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
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 |
Death
|
|
|
|
|
subjects affected / exposed
|
4 / 705 (0.57%) |
4 / 720 (0.56%) |
1 / 109 (0.92%) |
1 / 101 (0.99%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 4 |
0 / 1 |
0 / 1 |
Device battery issue
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 malfunction
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 occlusion
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
3 / 720 (0.42%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Disease progression
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
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 |
Fatigue
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
3 / 720 (0.42%) |
1 / 109 (0.92%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
General physical health deterioration
|
|
|
|
|
subjects affected / exposed
|
3 / 705 (0.43%) |
5 / 720 (0.69%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Generalised oedema
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hernia
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Impaired healing
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Local swelling
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Malaise
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
6 / 720 (0.83%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 6 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Multi-organ failure
|
|
|
|
|
subjects affected / exposed
|
2 / 705 (0.28%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
0 / 0 |
Non-cardiac chest pain
|
|
|
|
|
subjects affected / exposed
|
2 / 705 (0.28%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
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 |
Oedema peripheral
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
2 / 720 (0.28%) |
1 / 109 (0.92%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Pain
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Pyrexia
|
|
|
|
|
subjects affected / exposed
|
5 / 705 (0.71%) |
10 / 720 (1.39%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 15 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sudden cardiac death
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Sudden death
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Immune system disorders
|
|
|
|
|
Anaphylactic reaction
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Social circumstances
|
|
|
|
|
Physical disability
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
|
|
Benign prostatic hyperplasia
|
|
|
|
|
subjects affected / exposed
|
3 / 705 (0.43%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Pelvic pain
|
|
|
|
|
subjects affected / exposed
|
2 / 705 (0.28%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Perineal pain
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prostatic haemorrhage
|
|
|
|
|
subjects affected / exposed
|
3 / 705 (0.43%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prostatic obstruction
|
|
|
|
|
subjects affected / exposed
|
2 / 705 (0.28%) |
0 / 720 (0.00%) |
4 / 109 (3.67%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prostatic perforation
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prostatism
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
0 / 720 (0.00%) |
1 / 109 (0.92%) |
0 / 101 (0.00%) |
occurrences 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 |
Prostatomegaly
|
|
|
|
|
subjects affected / exposed
|
2 / 705 (0.28%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Scrotal oedema
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Testicular atrophy
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Testicular pain
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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, thoracic and mediastinal disorders
|
|
|
|
|
Acute pulmonary oedema
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Acute respiratory distress syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 respiratory failure
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
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 |
Aspiration
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Asthma
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atelectasis
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchomalacia
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 obstructive pulmonary disease
|
|
|
|
|
subjects affected / exposed
|
3 / 705 (0.43%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cough
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
|
|
subjects affected / exposed
|
7 / 705 (0.99%) |
10 / 720 (1.39%) |
0 / 109 (0.00%) |
3 / 101 (2.97%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 11 |
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Emphysema
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
0 / 720 (0.00%) |
1 / 109 (0.92%) |
0 / 101 (0.00%) |
occurrences 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 |
Epistaxis
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
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 |
Haemoptysis
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung disorder
|
|
|
|
|
subjects affected / exposed
|
2 / 705 (0.28%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Pleural effusion
|
|
|
|
|
subjects affected / exposed
|
5 / 705 (0.71%) |
3 / 720 (0.42%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Pleuritic pain
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 aspiration
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
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 |
Pneumonitis
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
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 |
Pneumothorax
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 arterial hypertension
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 embolism
|
|
|
|
|
subjects affected / exposed
|
8 / 705 (1.13%) |
9 / 720 (1.25%) |
1 / 109 (0.92%) |
3 / 101 (2.97%) |
occurrences causally related to treatment / all
|
1 / 8 |
2 / 9 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
0 / 1 |
Pulmonary fibrosis
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Pulmonary oedema
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 / 705 (0.14%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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
|
3 / 705 (0.43%) |
3 / 720 (0.42%) |
2 / 109 (1.83%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 1 |
0 / 0 |
Sinus disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sleep apnoea syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
|
|
Abnormal behaviour
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Completed suicide
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Confusional state
|
|
|
|
|
subjects affected / exposed
|
4 / 705 (0.57%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Delirium
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Depression
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Disorientation
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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
|
1 / 705 (0.14%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Investigations
|
|
|
|
|
Aspiration bronchial
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 creatinine increased
|
|
|
|
|
subjects affected / exposed
|
2 / 705 (0.28%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Blood potassium decreased
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 pressure increased
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 urine present
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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
|
2 / 705 (0.28%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Heart rate increased
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Laboratory test abnormal
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ultrasound liver abnormal
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Weight decreased
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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, poisoning and procedural complications
|
|
|
|
|
Accidental overdose
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
0 / 720 (0.00%) |
1 / 109 (0.92%) |
0 / 101 (0.00%) |
occurrences 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 |
Back injury
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cervical vertebral fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cystitis radiation
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Facial bones fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Fall
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
6 / 720 (0.83%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Femoral neck fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
3 / 720 (0.42%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
|
|
subjects affected / exposed
|
8 / 705 (1.13%) |
1 / 720 (0.14%) |
1 / 109 (0.92%) |
1 / 101 (0.99%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fibula fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Foreign body
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 radiation
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 stoma complication
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Head injury
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
0 / 720 (0.00%) |
1 / 109 (0.92%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hip fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Humerus fracture
|
|
|
|
|
subjects affected / exposed
|
2 / 705 (0.28%) |
3 / 720 (0.42%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Incisional hernia
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Laceration
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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
|
2 / 705 (0.28%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Post procedural haematuria
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Radius fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Retinal injury
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
1 / 109 (0.92%) |
0 / 101 (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 |
Road traffic accident
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Spinal compression fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sternal fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
0 / 720 (0.00%) |
1 / 109 (0.92%) |
0 / 101 (0.00%) |
occurrences 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 |
Subdural haematoma
|
|
|
|
|
subjects affected / exposed
|
2 / 705 (0.28%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Tendon rupture
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tibia fracture
|
|
|
|
|
subjects affected / exposed
|
3 / 705 (0.43%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Toxicity to various agents
|
|
|
|
|
subjects affected / exposed
|
3 / 705 (0.43%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Traumatic intracranial haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
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 |
Wrist fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
|
|
Phimosis
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Syringomyelia
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
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
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
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 |
Acute myocardial infarction
|
|
|
|
|
subjects affected / exposed
|
2 / 705 (0.28%) |
4 / 720 (0.56%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Angina pectoris
|
|
|
|
|
subjects affected / exposed
|
3 / 705 (0.43%) |
5 / 720 (0.69%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Angina unstable
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
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 |
Arrhythmia
|
|
|
|
|
subjects affected / exposed
|
4 / 705 (0.57%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrial fibrillation
|
|
|
|
|
subjects affected / exposed
|
12 / 705 (1.70%) |
6 / 720 (0.83%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
occurrences causally related to treatment / all
|
0 / 14 |
2 / 6 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Atrial flutter
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Atrial tachycardia
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
|
|
subjects affected / exposed
|
2 / 705 (0.28%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac arrest
|
|
|
|
|
subjects affected / exposed
|
3 / 705 (0.43%) |
2 / 720 (0.28%) |
1 / 109 (0.92%) |
1 / 101 (0.99%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
0 / 1 |
Cardiac failure
|
|
|
|
|
subjects affected / exposed
|
3 / 705 (0.43%) |
3 / 720 (0.42%) |
1 / 109 (0.92%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 1 |
0 / 0 |
Cardiac failure congestive
|
|
|
|
|
subjects affected / exposed
|
7 / 705 (0.99%) |
6 / 720 (0.83%) |
1 / 109 (0.92%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 7 |
1 / 6 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac tamponade
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 valve disease
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Cardio-respiratory arrest
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
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 |
Cardiogenic shock
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Cardiomyopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiopulmonary failure
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
3 / 720 (0.42%) |
0 / 109 (0.00%) |
0 / 101 (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 / 3 |
0 / 0 |
0 / 0 |
Cardiovascular insufficiency
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cor pulmonale
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
0 / 720 (0.00%) |
1 / 109 (0.92%) |
0 / 101 (0.00%) |
occurrences 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 |
Coronary artery disease
|
|
|
|
|
subjects affected / exposed
|
3 / 705 (0.43%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Coronary artery stenosis
|
|
|
|
|
subjects affected / exposed
|
3 / 705 (0.43%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Coronary artery thrombosis
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic cardiomyopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
0 / 720 (0.00%) |
1 / 109 (0.92%) |
0 / 101 (0.00%) |
occurrences 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 |
Left ventricular dysfunction
|
|
|
|
|
subjects affected / exposed
|
2 / 705 (0.28%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Myocardial infarction
|
|
|
|
|
subjects affected / exposed
|
10 / 705 (1.42%) |
12 / 720 (1.67%) |
4 / 109 (3.67%) |
1 / 101 (0.99%) |
occurrences causally related to treatment / all
|
1 / 10 |
0 / 12 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 6 |
0 / 1 |
0 / 0 |
Myocardial ischaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
6 / 720 (0.83%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 7 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pericardial effusion
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Right ventricular failure
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sick sinus syndrome
|
|
|
|
|
subjects affected / exposed
|
2 / 705 (0.28%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Sinus bradycardia
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Trifascicular block
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 hypertrophy
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular tachycardia
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
|
|
Aphasia
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ataxia
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Carotid artery stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Carotid artery thrombosis
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebellar infarction
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 infarction
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Cerebral ischaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Cerebrovascular accident
|
|
|
|
|
subjects affected / exposed
|
10 / 705 (1.42%) |
8 / 720 (1.11%) |
2 / 109 (1.83%) |
2 / 101 (1.98%) |
occurrences causally related to treatment / all
|
1 / 13 |
0 / 8 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
1 / 2 |
0 / 3 |
0 / 1 |
0 / 0 |
Cerebrovascular disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Complex partial seizures
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Convulsion
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Dementia
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
1 / 109 (0.92%) |
1 / 101 (0.99%) |
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 |
Dizziness
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
4 / 720 (0.56%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Encephalopathy
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
1 / 109 (0.92%) |
1 / 101 (0.99%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
|
|
subjects affected / exposed
|
3 / 705 (0.43%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Gait apraxia
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Grand mal convulsion
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypertonia
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
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 |
Lethargy
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Loss of consciousness
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neuropathy peripheral
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
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 |
Paraparesis
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Petit mal epilepsy
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
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 / 705 (0.14%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Somnolence
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal cord compression
|
|
|
|
|
subjects affected / exposed
|
2 / 705 (0.28%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Syncope
|
|
|
|
|
subjects affected / exposed
|
4 / 705 (0.57%) |
8 / 720 (1.11%) |
1 / 109 (0.92%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
1 / 6 |
1 / 9 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
2 / 720 (0.28%) |
1 / 109 (0.92%) |
1 / 101 (0.99%) |
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 |
Vertebral artery occlusion
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 and lymphatic system disorders
|
|
|
|
|
Anaemia
|
|
|
|
|
subjects affected / exposed
|
12 / 705 (1.70%) |
25 / 720 (3.47%) |
2 / 109 (1.83%) |
3 / 101 (2.97%) |
occurrences causally related to treatment / all
|
0 / 15 |
2 / 30 |
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Anaemia of malignant disease
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coagulopathy
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Febrile neutropenia
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
4 / 720 (0.56%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
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 |
Haemorrhagic anaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Iron deficiency anaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Lymphadenopathy
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Neutropenia
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 lymphadenopathy
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spontaneous haematoma
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
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 |
Ear and labyrinth disorders
|
|
|
|
|
Vertigo
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Eyelid ptosis
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Glaucoma
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Optic ischaemic neuropathy
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
|
|
Abdominal pain
|
|
|
|
|
subjects affected / exposed
|
6 / 705 (0.85%) |
3 / 720 (0.42%) |
1 / 109 (0.92%) |
1 / 101 (0.99%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 3 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain lower
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (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 abdomen
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anal fistula
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Ascites
|
|
|
|
|
subjects affected / exposed
|
3 / 705 (0.43%) |
2 / 720 (0.28%) |
1 / 109 (0.92%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Colitis
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Colitis ulcerative
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Constipation
|
|
|
|
|
subjects affected / exposed
|
2 / 705 (0.28%) |
3 / 720 (0.42%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Diarrhoea
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
4 / 720 (0.56%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulitis intestinal haemorrhagic
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
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 |
Diverticulum intestinal
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Diverticulum intestinal haemorrhagic
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Duodenal ulcer
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Dyspepsia
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Enterovesical fistula
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Faecaloma
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastric ulcer
|
|
|
|
|
subjects affected / exposed
|
2 / 705 (0.28%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Gastritis
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
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 |
Gastrointestinal angiodysplasia
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Gastrointestinal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
2 / 705 (0.28%) |
5 / 720 (0.69%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrooesophageal reflux disease
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Haematemesis
|
|
|
|
|
subjects affected / exposed
|
2 / 705 (0.28%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Haematochezia
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Haemorrhoidal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhoids
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Ileus
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
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 |
Ileus paralytic
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Inguinal hernia
|
|
|
|
|
subjects affected / exposed
|
3 / 705 (0.43%) |
4 / 720 (0.56%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal hernia, obstructive
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal mass
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal obstruction
|
|
|
|
|
subjects affected / exposed
|
4 / 705 (0.57%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intra-abdominal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Large intestinal stenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 perforation
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
2 / 720 (0.28%) |
1 / 109 (0.92%) |
0 / 101 (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 |
Large intestine polyp
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 gastrointestinal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Melaena
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Nausea
|
|
|
|
|
subjects affected / exposed
|
3 / 705 (0.43%) |
1 / 720 (0.14%) |
1 / 109 (0.92%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal rupture
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oesophagitis
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oral mucosa erosion
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Pancreatitis
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peptic ulcer perforation
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Periodontal disease
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
4 / 705 (0.57%) |
6 / 720 (0.83%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 8 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Small intestinal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
|
|
subjects affected / exposed
|
3 / 705 (0.43%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Subileus
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tongue haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Toothache
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
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 |
Upper gastrointestinal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Varices oesophageal
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vomiting
|
|
|
|
|
subjects affected / exposed
|
3 / 705 (0.43%) |
1 / 720 (0.14%) |
1 / 109 (0.92%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 1 |
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 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
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 stone
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholangitis
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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
|
1 / 705 (0.14%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Cholecystitis acute
|
|
|
|
|
subjects affected / exposed
|
2 / 705 (0.28%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Cholelithiasis
|
|
|
|
|
subjects affected / exposed
|
3 / 705 (0.43%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Cholestasis
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Hepatic failure
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Jaundice
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 and subcutaneous tissue disorders
|
|
|
|
|
Angioedema
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Dermatitis contact
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin ulcer
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 and urinary disorders
|
|
|
|
|
Anuria
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Azotaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
5 / 720 (0.69%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Bladder dilatation
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder neck obstruction
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
3 / 720 (0.42%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Bladder neck sclerosis
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder obstruction
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Bladder outlet obstruction
|
|
|
|
|
subjects affected / exposed
|
2 / 705 (0.28%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Bladder perforation
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Calculus bladder
|
|
|
|
|
subjects affected / exposed
|
3 / 705 (0.43%) |
3 / 720 (0.42%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Calculus ureteric
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
3 / 720 (0.42%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Calculus urinary
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Cystitis haemorrhagic
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cystitis noninfective
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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
|
3 / 705 (0.43%) |
7 / 720 (0.97%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 8 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haematinuria
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Haematuria
|
|
|
|
|
subjects affected / exposed
|
25 / 705 (3.55%) |
37 / 720 (5.14%) |
2 / 109 (1.83%) |
5 / 101 (4.95%) |
occurrences causally related to treatment / all
|
0 / 36 |
1 / 45 |
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhage urinary tract
|
|
|
|
|
subjects affected / exposed
|
2 / 705 (0.28%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Hydronephrosis
|
|
|
|
|
subjects affected / exposed
|
11 / 705 (1.56%) |
15 / 720 (2.08%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 18 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Hydroureter
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Incontinence
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Micturition disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Micturition urgency
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Nocturia
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Obstructive uropathy
|
|
|
|
|
subjects affected / exposed
|
2 / 705 (0.28%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (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 / 1 |
0 / 0 |
0 / 0 |
Oliguria
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pollakiuria
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
6 / 720 (0.83%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Polyuria
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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
|
9 / 705 (1.28%) |
16 / 720 (2.22%) |
1 / 109 (0.92%) |
2 / 101 (1.98%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 17 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 6 |
0 / 0 |
0 / 0 |
Renal failure acute
|
|
|
|
|
subjects affected / exposed
|
16 / 705 (2.27%) |
12 / 720 (1.67%) |
4 / 109 (3.67%) |
2 / 101 (1.98%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 14 |
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 1 |
0 / 0 |
Renal failure chronic
|
|
|
|
|
subjects affected / exposed
|
3 / 705 (0.43%) |
2 / 720 (0.28%) |
1 / 109 (0.92%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ureteric dilatation
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ureteric obstruction
|
|
|
|
|
subjects affected / exposed
|
4 / 705 (0.57%) |
3 / 720 (0.42%) |
0 / 109 (0.00%) |
0 / 101 (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 / 1 |
0 / 0 |
0 / 0 |
Ureteric stenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urethral obstruction
|
|
|
|
|
subjects affected / exposed
|
3 / 705 (0.43%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Urethral pain
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urethral stenosis
|
|
|
|
|
subjects affected / exposed
|
4 / 705 (0.57%) |
3 / 720 (0.42%) |
1 / 109 (0.92%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary bladder haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Urinary hesitation
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary incontinence
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
1 / 109 (0.92%) |
0 / 101 (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 |
Urinary retention
|
|
|
|
|
subjects affected / exposed
|
33 / 705 (4.68%) |
56 / 720 (7.78%) |
6 / 109 (5.50%) |
5 / 101 (4.95%) |
occurrences causally related to treatment / all
|
0 / 40 |
0 / 68 |
0 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Urinary tract disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Urinary tract obstruction
|
|
|
|
|
subjects affected / exposed
|
12 / 705 (1.70%) |
5 / 720 (0.69%) |
1 / 109 (0.92%) |
1 / 101 (0.99%) |
occurrences causally related to treatment / all
|
0 / 12 |
1 / 5 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract pain
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urine abnormality
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
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 |
Urogenital haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
|
|
Arthralgia
|
|
|
|
|
subjects affected / exposed
|
2 / 705 (0.28%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Arthritis
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Back pain
|
|
|
|
|
subjects affected / exposed
|
7 / 705 (0.99%) |
9 / 720 (1.25%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 9 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bone pain
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dupuytren's contracture
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Exostosis of jaw
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Flank pain
|
|
|
|
|
subjects affected / exposed
|
2 / 705 (0.28%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Fracture nonunion
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypercreatinaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Intervertebral disc degeneration
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Jaw disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Joint effusion
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar spinal stenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
1 / 109 (0.92%) |
0 / 101 (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 |
Muscular weakness
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Musculoskeletal chest pain
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal pain
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myalgia
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Neck pain
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteitis
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Osteoarthritis
|
|
|
|
|
subjects affected / exposed
|
4 / 705 (0.57%) |
7 / 720 (0.97%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
occurrences causally related to treatment / all
|
0 / 4 |
1 / 8 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteonecrosis of jaw
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
12 / 720 (1.67%) |
1 / 109 (0.92%) |
5 / 101 (4.95%) |
occurrences causally related to treatment / all
|
0 / 0 |
13 / 13 |
1 / 1 |
5 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
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 |
Rhabdomyolysis
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rheumatoid arthritis
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rotator cuff syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal osteoarthritis
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
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 |
Weight bearing difficulty
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
|
|
Abscess
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Abscess jaw
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
0 / 720 (0.00%) |
1 / 109 (0.92%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abscess of salivary gland
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 sinusitis
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
0 / 720 (0.00%) |
1 / 109 (0.92%) |
0 / 101 (0.00%) |
occurrences 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 |
Anal infection
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis bacterial
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
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 |
Arthritis infective
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bacteraemia
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Bronchitis
|
|
|
|
|
subjects affected / exposed
|
4 / 705 (0.57%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchopneumonia
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
3 / 720 (0.42%) |
1 / 109 (0.92%) |
0 / 101 (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 |
Cardiac infection
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
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 |
Cellulitis
|
|
|
|
|
subjects affected / exposed
|
4 / 705 (0.57%) |
6 / 720 (0.83%) |
1 / 109 (0.92%) |
2 / 101 (1.98%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chest wall abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 colitis
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
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 |
Cystitis
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Dental fistula
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 related infection
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 related sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Diverticulitis
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
2 / 720 (0.28%) |
1 / 109 (0.92%) |
2 / 101 (1.98%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Empyema
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Endocarditis
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Enterococcal infection
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Epiglottitis
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Gangrene
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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
|
2 / 705 (0.28%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
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 |
Gastrointestinal infection
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gingival abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
0 / 720 (0.00%) |
1 / 109 (0.92%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Herpes zoster
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Human ehrlichiosis
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infected skin ulcer
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
0 / 720 (0.00%) |
1 / 109 (0.92%) |
0 / 101 (0.00%) |
occurrences 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 |
Liver abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lobar pneumonia
|
|
|
|
|
subjects affected / exposed
|
2 / 705 (0.28%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Localised infection
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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
|
1 / 705 (0.14%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Lung infection
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Neutropenic infection
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oral candidiasis
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Orchitis
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
4 / 720 (0.56%) |
1 / 109 (0.92%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 6 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteomyelitis acute
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteomyelitis chronic
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Penile infection
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Perineal abscess
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Perineal infection
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Pneumonia
|
|
|
|
|
subjects affected / exposed
|
16 / 705 (2.27%) |
13 / 720 (1.81%) |
2 / 109 (1.83%) |
1 / 101 (0.99%) |
occurrences causally related to treatment / all
|
0 / 16 |
1 / 14 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia pneumococcal
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pseudomonal sepsis
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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 tuberculosis
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
|
|
subjects affected / exposed
|
2 / 705 (0.28%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Rectal abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Scrotal abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to 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
|
8 / 705 (1.13%) |
6 / 720 (0.83%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 6 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 0 |
0 / 0 |
Septic shock
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
1 / 720 (0.14%) |
2 / 109 (1.83%) |
0 / 101 (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 / 1 |
0 / 2 |
0 / 0 |
Sialoadenitis
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tooth infection
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
0 / 720 (0.00%) |
1 / 109 (0.92%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Upper respiratory tract infection
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
|
|
subjects affected / exposed
|
15 / 705 (2.13%) |
15 / 720 (2.08%) |
2 / 109 (1.83%) |
3 / 101 (2.97%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 19 |
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract infection bacterial
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
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 |
Urosepsis
|
|
|
|
|
subjects affected / exposed
|
4 / 705 (0.57%) |
3 / 720 (0.42%) |
0 / 109 (0.00%) |
2 / 101 (1.98%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Viral infection
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wound infection
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Metabolism and nutrition disorders
|
|
|
|
|
Cachexia
|
|
|
|
|
subjects affected / exposed
|
3 / 705 (0.43%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
Decreased appetite
|
|
|
|
|
subjects affected / exposed
|
2 / 705 (0.28%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Dehydration
|
|
|
|
|
subjects affected / exposed
|
9 / 705 (1.28%) |
7 / 720 (0.97%) |
0 / 109 (0.00%) |
3 / 101 (2.97%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 7 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetes mellitus
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Diabetes mellitus inadequate control
|
|
|
|
|
subjects affected / exposed
|
2 / 705 (0.28%) |
2 / 720 (0.28%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Electrolyte imbalance
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gout
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypocalcaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
1 / 720 (0.14%) |
2 / 109 (1.83%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
2 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
3 / 720 (0.42%) |
0 / 109 (0.00%) |
1 / 101 (0.99%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
1 / 720 (0.14%) |
1 / 109 (0.92%) |
0 / 101 (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 |
Hypovolaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 705 (0.00%) |
0 / 720 (0.00%) |
1 / 109 (0.92%) |
0 / 101 (0.00%) |
occurrences 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 |
Iron deficiency
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malnutrition
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
1 / 720 (0.14%) |
0 / 109 (0.00%) |
0 / 101 (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 |
Type 2 diabetes mellitus
|
|
|
|
|
subjects affected / exposed
|
1 / 705 (0.14%) |
0 / 720 (0.00%) |
0 / 109 (0.00%) |
0 / 101 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |