Serious adverse events
|
Cohort A: SC Herceptin by Needle/Syringe |
Cohort A: SC Herceptin by Needle/Syringe Safety Follow-up |
Cohort B: SC Herceptin by SID Safety Follow-up |
Cohort B: SC Herceptin by Single-Use Injection Device (SID) |
Total subjects affected by serious adverse events
|
|
|
|
|
subjects affected / exposed
|
242 / 1864 (12.98%) |
202 / 1862 (10.85%) |
53 / 707 (7.50%) |
84 / 709 (11.85%) |
number of deaths (all causes)
|
28 |
98 |
45 |
6 |
number of deaths resulting from adverse events
|
|
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
|
Uterine leiomyoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
2 / 709 (0.28%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Benign pancreatic neoplasm
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Borderline serous tumour of ovary
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Breast cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
15 / 1862 (0.81%) |
1 / 707 (0.14%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 15 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Clear cell renal cell carcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colon cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
2 / 1862 (0.11%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Endometrial cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intraductal proliferative breast lesion
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
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 |
Ovarian fibroma
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Schwannoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thyroid adenoma
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Uterine Cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
2 / 1862 (0.11%) |
1 / 707 (0.14%) |
0 / 709 (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 |
Papillary Thyroid Cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
1 / 707 (0.14%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ovarian Cancer Recurrent
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
1 / 707 (0.14%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ovarian Cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
1 / 707 (0.14%) |
0 / 709 (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 |
Metastatic Gastric Cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
1 / 707 (0.14%) |
0 / 709 (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 |
Lung Neoplasm Malignant
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
2 / 1862 (0.11%) |
1 / 707 (0.14%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
Lung Cancer Metastatic
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
1 / 707 (0.14%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal Carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
1 / 707 (0.14%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastric Cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
1 / 707 (0.14%) |
0 / 709 (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 |
Adenocarcinoma of Colon
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
1 / 707 (0.14%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Vulval Cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thyroid Cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to 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 Cell Carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to 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
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
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 |
Ovarian Epithelial Cancer Metastatic
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
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 |
Non-Hodgkin's Lymphoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lymphocytic Lymphoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Invasive Lobular Breast Carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Invasive Ductal Breast Carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatocellular Carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Glioma
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Glioblastoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Endometrial Adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colon Cancer Metastatic
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
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 |
Chondroma
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Breast Sarcoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Breast Neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to 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 Cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Basal Cell Carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Synovial Sarcoma Metastatic
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Malignant Melanoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
3 / 1862 (0.16%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Vascular disorders
|
|
|
|
|
Hypertension
|
|
|
|
|
subjects affected / exposed
|
2 / 1864 (0.11%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive crisis
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
2 / 1862 (0.11%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
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 |
Aortic aneurysm
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arterial stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
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 |
Deep vein thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
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 |
Orthostatic hypotension
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
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 |
Phlebitis
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Venous thrombosis
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thromboangiitis Obliterans
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
1 / 707 (0.14%) |
0 / 709 (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 |
Varicose Vein
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive Urgency
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pregnancy, puerperium and perinatal conditions
|
|
|
|
|
Anembryonic Gestation
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
|
|
Pyrexia
|
|
|
|
|
subjects affected / exposed
|
11 / 1864 (0.59%) |
1 / 1862 (0.05%) |
1 / 707 (0.14%) |
7 / 709 (0.99%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 1 |
0 / 1 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device breakage
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
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 |
General physical health deterioration
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Asthenia
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Chest discomfort
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
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 |
Chest pain
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
2 / 1862 (0.11%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Death
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
6 / 1862 (0.32%) |
1 / 707 (0.14%) |
1 / 709 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 6 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 6 |
0 / 1 |
0 / 1 |
Device defective
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fatigue
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
1 / 707 (0.14%) |
0 / 709 (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 |
Influenza like illness
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mucosal inflammation
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to 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-cardiac chest pain
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sudden Death
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
|
|
Drug hypersensitivity
|
|
|
|
|
subjects affected / exposed
|
2 / 1864 (0.11%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Hypersensitivity
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
2 / 709 (0.28%) |
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 |
Anaphylactic Shock
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
1 / 707 (0.14%) |
0 / 709 (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 |
Reproductive system and breast disorders
|
|
|
|
|
Uterine polyp
|
|
|
|
|
subjects affected / exposed
|
2 / 1864 (0.11%) |
3 / 1862 (0.16%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Breast fibrosis
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
1 / 707 (0.14%) |
0 / 709 (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 |
Endometrial hypertrophy
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ovarian cyst
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
2 / 1862 (0.11%) |
1 / 707 (0.14%) |
0 / 709 (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 |
Postmenopausal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Uterine haemorrhage
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Breast Necrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
1 / 707 (0.14%) |
0 / 709 (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 |
Breast Calcifications
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
1 / 707 (0.14%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Endometrial Hyperplasia
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Cervical Dysplasia
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fibrocystic Breast Disease
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vaginal Haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
|
Asthma
|
|
|
|
|
subjects affected / exposed
|
2 / 1864 (0.11%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
|
|
subjects affected / exposed
|
2 / 1864 (0.11%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Pneumonitis
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
4 / 1862 (0.21%) |
1 / 707 (0.14%) |
2 / 709 (0.28%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Dyspnoea exertional
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
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 |
Organising pneumonia
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
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 |
Painful respiration
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pleurisy
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary oedema
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Respiratory failure
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic Obstructive Pulmonary Disease
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
1 / 707 (0.14%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Obstructive Airways Disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
1 / 707 (0.14%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pleural Effusion
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
2 / 1862 (0.11%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Epistaxis
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to 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 Sarcoidosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
|
|
Anxiety
|
|
|
|
|
subjects affected / exposed
|
2 / 1864 (0.11%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Depression
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
2 / 1862 (0.11%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
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 |
Panic attack
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Psychotic disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Investigations
|
|
|
|
|
Ejection fraction decreased
|
|
|
|
|
subjects affected / exposed
|
3 / 1864 (0.16%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
2 / 3 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
White blood cell count decreased
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood urea increased
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Electrocardiogram QT prolonged
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neutrophil count decreased
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Injury, poisoning and procedural complications
|
|
|
|
|
Radiation pneumonitis
|
|
|
|
|
subjects affected / exposed
|
2 / 1864 (0.11%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Hip fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
1 / 1862 (0.05%) |
1 / 707 (0.14%) |
1 / 709 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wound dehiscence
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
1 / 707 (0.14%) |
1 / 709 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Concussion
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fibula fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to 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 displacement
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
1 / 707 (0.14%) |
0 / 709 (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 |
Laceration
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
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 |
Lumbar vertebral fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Patella fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to 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 / 1864 (0.05%) |
2 / 1862 (0.11%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Seroma
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to 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 fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to 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
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic arthropathy
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
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 |
Ulna fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wound
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pubis Fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
1 / 707 (0.14%) |
0 / 709 (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 |
Lower Limb Fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
1 / 707 (0.14%) |
0 / 709 (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 |
Foreign Body Aspiration
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
1 / 707 (0.14%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Foot Fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
1 / 707 (0.14%) |
0 / 709 (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 |
Fall
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
2 / 707 (0.28%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wrist Fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thoracic Vertebral Fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Post Procedural Haematoma
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Joint Dislocation
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Incisional Hernia
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to 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 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Craniocerebral Injury
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intentional Overdose
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Spinal Compression Fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
2 / 1862 (0.11%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Rib Fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
2 / 1862 (0.11%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Humerus Fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
2 / 1862 (0.11%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Clavicle Fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
2 / 1862 (0.11%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Femoral Neck Fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
3 / 1862 (0.16%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Ankle Fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
3 / 1862 (0.16%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Cardiac disorders
|
|
|
|
|
Cardiac failure congestive
|
|
|
|
|
subjects affected / exposed
|
10 / 1864 (0.54%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
occurrences causally related to treatment / all
|
9 / 10 |
1 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrial fibrillation
|
|
|
|
|
subjects affected / exposed
|
2 / 1864 (0.11%) |
6 / 1862 (0.32%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
2 / 3 |
0 / 6 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Angina unstable
|
|
|
|
|
subjects affected / exposed
|
2 / 1864 (0.11%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Coronary artery disease
|
|
|
|
|
subjects affected / exposed
|
2 / 1864 (0.11%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Left ventricular dysfunction
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myocardial ischaemia
|
|
|
|
|
subjects affected / exposed
|
2 / 1864 (0.11%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Pericarditis
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
|
|
subjects affected / exposed
|
2 / 1864 (0.11%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Acute myocardial infarction
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
3 / 1862 (0.16%) |
3 / 707 (0.42%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Atrial thrombosis
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular block second degree
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Myocarditis
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Palpitations
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
1 / 707 (0.14%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Stress cardiomyopathy
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Ventricular arrhythmia
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intracardiac Thrombus
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
1 / 707 (0.14%) |
0 / 709 (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 |
Myocardial Infarction
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
6 / 1862 (0.32%) |
0 / 707 (0.00%) |
0 / 709 (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 / 0 |
0 / 0 |
0 / 0 |
Acute Coronary Syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Angina Pectoris
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arteriosclerosis Coronary Artery
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
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 |
Atrial Flutter
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrial Tachycardia
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to 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 Hypertrophy
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
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 |
Cardio-Respiratory Arrest
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
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 |
Tachycardia
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to 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
|
|
|
|
|
Headache
|
|
|
|
|
subjects affected / exposed
|
2 / 1864 (0.11%) |
2 / 1862 (0.11%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Syncope
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
2 / 1862 (0.11%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aphasia
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Carotid sinus syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Cerebral ischaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
1 / 707 (0.14%) |
0 / 709 (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 |
Cerebrovascular accident
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
2 / 1862 (0.11%) |
2 / 707 (0.28%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
Depressed level of consciousness
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Generalised tonic-clonic seizure
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
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 |
Peripheral sensorimotor neuropathy
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Presyncope
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tension headache
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
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 |
Transient ischaemic attack
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
1 / 1862 (0.05%) |
1 / 707 (0.14%) |
0 / 709 (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 |
Seizure
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
1 / 707 (0.14%) |
0 / 709 (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 |
Relapsing-Remitting Multiple Sclerosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
1 / 707 (0.14%) |
0 / 709 (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 |
Dementia Alzheimer's Type
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
1 / 707 (0.14%) |
0 / 709 (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 |
Dementia
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
1 / 707 (0.14%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral Infarction
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
1 / 707 (0.14%) |
0 / 709 (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 |
Amyotrophic Lateral Sclerosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
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 |
Cerebral Haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
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 |
Cerebrovascular Disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
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 |
Dizziness
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhagic Stroke
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hydrocephalus
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
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 |
Sciatica
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to 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
|
|
|
|
|
Febrile neutropenia
|
|
|
|
|
subjects affected / exposed
|
39 / 1864 (2.09%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
14 / 709 (1.97%) |
occurrences causally related to treatment / all
|
5 / 39 |
0 / 1 |
0 / 0 |
1 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neutropenia
|
|
|
|
|
subjects affected / exposed
|
9 / 1864 (0.48%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
6 / 709 (0.85%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 0 |
0 / 0 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Febrile bone marrow aplasia
|
|
|
|
|
subjects affected / exposed
|
2 / 1864 (0.11%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
2 / 709 (0.28%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anaemia
|
|
|
|
|
subjects affected / exposed
|
3 / 1864 (0.16%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Leukocytosis
|
|
|
|
|
subjects affected / exposed
|
2 / 1864 (0.11%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Leukopenia
|
|
|
|
|
subjects affected / exposed
|
2 / 1864 (0.11%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Pancytopenia
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thymus enlargement
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lymphadenopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
|
|
Vertigo
|
|
|
|
|
subjects affected / exposed
|
2 / 1864 (0.11%) |
1 / 1862 (0.05%) |
1 / 707 (0.14%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Meniere's disease
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
|
|
Keratitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
|
|
Diarrhoea
|
|
|
|
|
subjects affected / exposed
|
8 / 1864 (0.43%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
4 / 709 (0.56%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 0 |
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nausea
|
|
|
|
|
subjects affected / exposed
|
5 / 1864 (0.27%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
|
|
subjects affected / exposed
|
3 / 1864 (0.16%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis acute
|
|
|
|
|
subjects affected / exposed
|
2 / 1864 (0.11%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Vomiting
|
|
|
|
|
subjects affected / exposed
|
2 / 1864 (0.11%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Abdominal pain
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Abdominal discomfort
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colitis
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Constipation
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastritis erosive
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal pain
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal polyp
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
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 |
Neutropenic colitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
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 |
Subileus
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal Hernia
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
1 / 707 (0.14%) |
0 / 709 (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 Fissure
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastritis
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to 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
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulum Intestinal
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Food Poisoning
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hiatus Hernia
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to 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
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Upper Gastrointestinal Haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
|
|
Cholelithiasis
|
|
|
|
|
subjects affected / exposed
|
2 / 1864 (0.11%) |
3 / 1862 (0.16%) |
2 / 707 (0.28%) |
1 / 709 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis chronic
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
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 |
Cholecystitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
1 / 707 (0.14%) |
0 / 709 (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 |
Hepatic Failure
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
1 / 707 (0.14%) |
0 / 709 (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 |
Hepatic Steatosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
1 / 707 (0.14%) |
0 / 709 (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 |
Bile Duct Obstruction
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bile Duct Stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
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 |
Cholangitis Acute
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to 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 and subcutaneous tissue disorders
|
|
|
|
|
Dermatitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
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 |
Dermatitis bullous
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
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 |
Erythema nodosum
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rash
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Toxic skin eruption
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
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 |
Transient acantholytic dermatosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
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 |
Lichen Sclerosus
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Erythema
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
2 / 1862 (0.11%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Renal and urinary disorders
|
|
|
|
|
Renal failure
|
|
|
|
|
subjects affected / exposed
|
2 / 1864 (0.11%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Hydronephrosis
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to 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 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to 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 retention
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to 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 Bladder Polyp
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nephrotic Syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
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 |
Nephrolithiasis
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haematuria
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to 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 Colic
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
2 / 1862 (0.11%) |
0 / 707 (0.00%) |
0 / 709 (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 Kidney Injury
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
2 / 1862 (0.11%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Endocrine disorders
|
|
|
|
|
Hypothyroidism
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
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 |
Thyroiditis Subacute
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to 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
|
|
|
|
|
Osteoarthritis
|
|
|
|
|
subjects affected / exposed
|
2 / 1864 (0.11%) |
1 / 1862 (0.05%) |
1 / 707 (0.14%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Intervertebral disc protrusion
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
1 / 1862 (0.05%) |
1 / 707 (0.14%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar spinal stenosis
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myalgia
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rheumatoid arthritis
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to 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 Stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Scleroderma
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to 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 Disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mobility Decreased
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to 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
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arthralgia
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
|
|
Neutropenic sepsis
|
|
|
|
|
subjects affected / exposed
|
9 / 1864 (0.48%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
occurrences causally related to treatment / all
|
1 / 9 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Device related infection
|
|
|
|
|
subjects affected / exposed
|
6 / 1864 (0.32%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
|
|
subjects affected / exposed
|
5 / 1864 (0.27%) |
8 / 1862 (0.43%) |
2 / 707 (0.28%) |
1 / 709 (0.14%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 8 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
|
|
subjects affected / exposed
|
3 / 1864 (0.16%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
2 / 709 (0.28%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mastitis
|
|
|
|
|
subjects affected / exposed
|
3 / 1864 (0.16%) |
4 / 1862 (0.21%) |
0 / 707 (0.00%) |
2 / 709 (0.28%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
|
|
subjects affected / exposed
|
4 / 1864 (0.21%) |
4 / 1862 (0.21%) |
1 / 707 (0.14%) |
0 / 709 (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 |
Gastroenteritis
|
|
|
|
|
subjects affected / exposed
|
3 / 1864 (0.16%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lower respiratory tract infection
|
|
|
|
|
subjects affected / exposed
|
4 / 1864 (0.21%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
|
|
subjects affected / exposed
|
2 / 1864 (0.11%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
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 |
Upper respiratory tract infection
|
|
|
|
|
subjects affected / exposed
|
2 / 1864 (0.11%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Breast abscess
|
|
|
|
|
subjects affected / exposed
|
2 / 1864 (0.11%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Erysipelas
|
|
|
|
|
subjects affected / exposed
|
2 / 1864 (0.11%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Infectious colitis
|
|
|
|
|
subjects affected / exposed
|
2 / 1864 (0.11%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Pyelonephritis acute
|
|
|
|
|
subjects affected / exposed
|
2 / 1864 (0.11%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Viral infection
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infective exacerbation of chronic obstructive airways disease
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
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 |
Abscess of external auditory meatus
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Appendiceal abscess
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bartholin's abscess
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Breast cellulitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
2 / 1862 (0.11%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
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 |
Bronchopneumonia
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium difficile infection
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dengue fever
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Febrile infection
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to 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 rotavirus
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis B
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Herpes zoster
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Intestinal sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
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 |
Lobar pneumonia
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung infection
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Lymph node tuberculosis
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Meningoencephalitis bacterial
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Periorbital cellulitis
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia bacterial
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative wound infection
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
2 / 1862 (0.11%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Pyelonephritis
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to 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 infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
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 |
Soft tissue infection
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Staphylococcal infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
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 |
Tracheobronchitis
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
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 |
Vaginal infection
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wound infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
2 / 1862 (0.11%) |
0 / 707 (0.00%) |
1 / 709 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia Influenzal
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
1 / 707 (0.14%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia Streptococcal
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
1 / 707 (0.14%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to 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 Sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
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 |
Post Procedural Cellulitis
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Kidney Infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis Viral
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Enterobacter Sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to 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
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic Gangrene
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dengue Haemorrhagic Fever
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to 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 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Biliary Tract Infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infection
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
2 / 1862 (0.11%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Escherichia Sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
2 / 1862 (0.11%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Metabolism and nutrition disorders
|
|
|
|
|
Hyperglycaemia
|
|
|
|
|
subjects affected / exposed
|
2 / 1864 (0.11%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (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 |
Electrolyte imbalance
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gout
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
|
|
subjects affected / exposed
|
1 / 1864 (0.05%) |
0 / 1862 (0.00%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Decreased Appetite
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
1 / 707 (0.14%) |
0 / 709 (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 |
Diabetes Mellitus
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
1 / 1862 (0.05%) |
0 / 707 (0.00%) |
0 / 709 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 1864 (0.00%) |
0 / 1862 (0.00%) |
1 / 707 (0.14%) |
0 / 709 (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 |