Serious adverse events
|
Insuman comparative phase |
Insuplant comparative phase |
Insuplant phase |
Insuman phase |
Total subjects affected by serious adverse events
|
|
|
|
|
subjects affected / exposed
|
64 / 83 (77.11%) |
61 / 82 (74.39%) |
113 / 159 (71.07%) |
101 / 148 (68.24%) |
number of deaths (all causes)
|
1 |
2 |
3 |
5 |
number of deaths resulting from adverse events
|
|
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
|
Adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bladder Cancer
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Breast Cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
3 / 159 (1.89%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Breast Neoplasm
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 |
Hodgkin's Disease Lymphocyte Depletion Type Stage Iii
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to 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 Adenocarcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Meningioma
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metastatic Gastric Cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Prostate Cancer
|
|
|
|
|
subjects affected / exposed
|
2 / 83 (2.41%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (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 |
Renal Cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 |
Squamous Cell Carcinoma
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
|
|
Adventitial Cystic Disease
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Arterial Disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arterial Insufficiency
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Arterial Occlusive Disease
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Arteriosclerosis
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Arteritis
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 |
Embolism Venous
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Hypertension
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Intermittent Claudication
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Orthostatic Hypotension
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral Arterial Occlusive Disease
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
1 / 82 (1.22%) |
1 / 159 (0.63%) |
1 / 148 (0.68%) |
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 |
Peripheral Artery Occlusion
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 Artery Stenosis
|
|
|
|
|
subjects affected / exposed
|
2 / 83 (2.41%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Peripheral Ischaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
1 / 159 (0.63%) |
0 / 148 (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 |
Phlebitis
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Superior Vena Cava Stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
|
|
Arterial Therapeutic Procedure
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 |
Breast Prosthesis Implantation
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (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 |
Caesarean Section
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Cataract Operation
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
2 / 159 (1.26%) |
0 / 148 (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 |
Cholecystectomy
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coronary Angioplasty
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Coronary Artery Bypass
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coronary Revascularisation
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cyst Removal
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Finger Repair Operation
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 Bypass
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Hospitalisation
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 |
Hysterectomy
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Leg Amputation
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Mammoplasty
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (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 |
Medical Device Change
|
|
|
|
|
subjects affected / exposed
|
3 / 83 (3.61%) |
7 / 82 (8.54%) |
11 / 159 (6.92%) |
2 / 148 (1.35%) |
occurrences causally related to treatment / all
|
3 / 4 |
8 / 8 |
10 / 11 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Medical Device Implantation
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Medical Device Removal
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
3 / 82 (3.66%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 1 |
3 / 3 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ovarian Cystectomy
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (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 |
Pancreas Transplant
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 |
Percutaneous Coronary Intervention
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral Nerve Operation
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 Revascularisation
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prostatic Operation
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to 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 Sympathetic Nerve Ablation
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal Transplant
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 |
Retinal Operation
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rotator Cuff Repair
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sinus Operation
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 |
Stent Placement
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Surgical Vascular Shunt
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Tendon Operation
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Toe Amputation
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Transplant
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 |
Pregnancy, puerperium and perinatal conditions
|
|
|
|
|
Delivery
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Live Birth
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Pre-Eclampsia
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 |
Pregnancy
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
5 / 148 (3.38%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Unintended Pregnancy
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to 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
|
|
|
|
|
Asthenia
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
1 / 159 (0.63%) |
0 / 148 (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 |
Catheter Site Pain
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (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 |
Chest Pain
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
1 / 82 (1.22%) |
1 / 159 (0.63%) |
2 / 148 (1.35%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
General Physical Health Deterioration
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 |
Generalised Oedema
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 |
Granuloma
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Impaired Healing
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malaise
|
|
|
|
|
subjects affected / exposed
|
2 / 83 (2.41%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (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 |
Medical Device Site Atrophy
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Medical Device Site Erosion
|
|
|
|
|
subjects affected / exposed
|
2 / 83 (2.41%) |
1 / 82 (1.22%) |
1 / 159 (0.63%) |
3 / 148 (2.03%) |
occurrences causally related to treatment / all
|
2 / 2 |
2 / 2 |
1 / 1 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Medical Device Site Erythema
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (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 |
Medical Device Site Haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
3 / 148 (2.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Medical Device Site Inflammation
|
|
|
|
|
subjects affected / exposed
|
3 / 83 (3.61%) |
1 / 82 (1.22%) |
1 / 159 (0.63%) |
2 / 148 (1.35%) |
occurrences causally related to treatment / all
|
3 / 3 |
1 / 1 |
1 / 1 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Medical Device Site Pain
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
11 / 148 (7.43%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
10 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oedema
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oedema Due To Cardiac Disease
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 |
Oedema Peripheral
|
|
|
|
|
subjects affected / exposed
|
2 / 83 (2.41%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Prolapse
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 |
Pyrexia
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
2 / 148 (1.35%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sudden Death
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Swelling
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
|
|
Amyloidosis
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Anaphylactic Shock
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Drug Hypersensitivity
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
2 / 148 (1.35%) |
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 |
Insulin Autoimmune Syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
|
|
Breast Enlargement
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Genital Prolapse
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to 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 Ovarian Cyst
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Menometrorrhagia
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metrorrhagia
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ovarian Cyst
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 |
Uterine Polyp
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
|
Acute Pulmonary Oedema
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Asthma
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic Obstructive Pulmonary Disease
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
2 / 148 (1.35%) |
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 |
Dyspnoea Exertional
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 |
Haemoptysis
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oropharyngeal Pain
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary Embolism
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
2 / 148 (1.35%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Pulmonary Oedema
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Sleep Apnoea Syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
|
|
Depression
|
|
|
|
|
subjects affected / exposed
|
3 / 83 (3.61%) |
0 / 82 (0.00%) |
2 / 159 (1.26%) |
2 / 148 (1.35%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Major Depression
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mania
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 |
Psychiatric Decompensation
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Sleep Disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Suicidal Ideation
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Suicide Attempt
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Investigations
|
|
|
|
|
Blood Glucose Fluctuation
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood Glucose Increased
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
2 / 159 (1.26%) |
2 / 148 (1.35%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
2 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiovascular Evaluation
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 |
Heart Rate Increased
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Laparoscopy
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Medical Observation
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Weight Increased
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
|
|
Abdominal Wall Wound
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Accidental Exposure To Product
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Accidental Overdose
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 |
Acetabulum Fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Animal Bite
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ankle Fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
2 / 159 (1.26%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Clavicle Fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
1 / 159 (0.63%) |
0 / 148 (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 |
Complications Of Transplanted Pancreas
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Concussion
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 |
Electric Shock
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 / 83 (0.00%) |
1 / 82 (1.22%) |
3 / 159 (1.89%) |
2 / 148 (1.35%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Femoral Neck Fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Femur Fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
3 / 159 (1.89%) |
2 / 148 (1.35%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Foot Fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 |
Humerus Fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
2 / 159 (1.26%) |
0 / 148 (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 |
Injury
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (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 |
Joint Dislocation
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Ligament Sprain
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Limb Injury
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
3 / 148 (2.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Lower Limb Fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Procedural Nausea
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Pubis Fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Road Traffic Accident
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Scapula Fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 |
Scar
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin Injury
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subarachnoid Haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subdural Haematoma
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Thoracic Vertebral Fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tibia Fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (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 |
Ulna Fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Upper Limb Fracture
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vth Nerve Injury
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wound Dehiscence
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wrist Fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
|
|
Acute Coronary Syndrome
|
|
|
|
|
subjects affected / exposed
|
2 / 83 (2.41%) |
1 / 82 (1.22%) |
2 / 159 (1.26%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Angina Pectoris
|
|
|
|
|
subjects affected / exposed
|
2 / 83 (2.41%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic Valve Stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrial Fibrillation
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
2 / 148 (1.35%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Cardiac Arrest
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
2 / 159 (1.26%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Cardiac Disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac Failure
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiovascular Disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Coronary Artery Disease
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
1 / 159 (0.63%) |
0 / 148 (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 |
Coronary Artery Stenosis
|
|
|
|
|
subjects affected / exposed
|
2 / 83 (2.41%) |
1 / 82 (1.22%) |
3 / 159 (1.89%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic Cardiomyopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
2 / 148 (1.35%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Myocardial Ischaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 |
Tachycardia
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 |
Nervous system disorders
|
|
|
|
|
Balance Disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Carotid Artery Stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 |
Carpal Tunnel Syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
1 / 82 (1.22%) |
3 / 159 (1.89%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebrovascular Accident
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
2 / 82 (2.44%) |
3 / 159 (1.89%) |
5 / 148 (3.38%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Dizziness
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Extrapyramidal Disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Headache
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
2 / 148 (1.35%) |
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 |
Hypoglycaemic Coma
|
|
|
|
|
subjects affected / exposed
|
8 / 83 (9.64%) |
5 / 82 (6.10%) |
8 / 159 (5.03%) |
6 / 148 (4.05%) |
occurrences causally related to treatment / all
|
6 / 26 |
1 / 6 |
4 / 13 |
3 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
Hypoglycaemic Seizure
|
|
|
|
|
subjects affected / exposed
|
3 / 83 (3.61%) |
2 / 82 (2.44%) |
2 / 159 (1.26%) |
2 / 148 (1.35%) |
occurrences causally related to treatment / all
|
1 / 5 |
2 / 2 |
1 / 2 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypoglycaemic Unconsciousness
|
|
|
|
|
subjects affected / exposed
|
6 / 83 (7.23%) |
2 / 82 (2.44%) |
13 / 159 (8.18%) |
6 / 148 (4.05%) |
occurrences causally related to treatment / all
|
1 / 17 |
1 / 2 |
5 / 19 |
3 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lacunar Stroke
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Loss Of Consciousness
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Migraine
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Nerve Compression
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neuralgia
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
1 / 159 (0.63%) |
2 / 148 (1.35%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Paraesthesia
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Presyncope
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
2 / 159 (1.26%) |
0 / 148 (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 |
Sciatica
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Seizure
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Syncope
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Transient Ischaemic Attack
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
2 / 159 (1.26%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
|
|
Microcytic Anaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pernicious Anaemia
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
|
|
Meniere's Disease
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Otosclerosis
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vertigo
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
3 / 82 (3.66%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
|
|
Cataract
|
|
|
|
|
subjects affected / exposed
|
3 / 83 (3.61%) |
3 / 82 (3.66%) |
2 / 159 (1.26%) |
2 / 148 (1.35%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic Retinopathy
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Retinal Aneurysm
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Retinal Detachment
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Retinal Haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Retinal Vein Occlusion
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 |
Vitreous Haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
|
|
Abdominal Discomfort
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Abdominal Hernia
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal Pain
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
1 / 82 (1.22%) |
1 / 159 (0.63%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 2 |
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal Pain Upper
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
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 / 83 (1.20%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhoidal Haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Impaired Gastric Emptying
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
2 / 159 (1.26%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal Hernia
|
|
|
|
|
subjects affected / exposed
|
2 / 83 (2.41%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Intestinal Obstruction
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to 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 Prolapse
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Intra-Abdominal Haematoma
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Mesenteric Artery Thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nausea
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
3 / 148 (2.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatic Cyst
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal Prolapse
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Umbilical Hernia
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
4 / 159 (2.52%) |
2 / 148 (1.35%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vomiting
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
9 / 148 (6.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
|
|
Cholecystitis Acute
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Cholelithiasis
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Drug-Induced Liver Injury
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 |
Hepatic Mass
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Skin and subcutaneous tissue disorders
|
|
|
|
|
Blister
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Decubitus Ulcer
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dermatitis
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (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 |
Diabetic Foot
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Eczema
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Hidradenitis
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin Erosion
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin Lesion
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin Ulcer
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
|
|
Acute Kidney Injury
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to 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 Irritation
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic Nephropathy
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
2 / 148 (1.35%) |
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 |
End Stage Renal Disease
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Incontinence
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal Colic
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal Failure
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
3 / 159 (1.89%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Renal Impairment
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary Bladder Polyp
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to 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
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
2 / 159 (1.26%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
|
|
Thyroid Mass
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
|
|
Arthralgia
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
2 / 148 (1.35%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arthropathy
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Back Pain
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bursitis
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Diastasis Recti Abdominis
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Foot Deformity
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral Disc Disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral Disc Protrusion
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 Spinal Stenosis
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
2 / 82 (2.44%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal Pain
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
2 / 82 (2.44%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteitis
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Osteoarthritis
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (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 |
Osteonecrosis Of Jaw
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 |
Pain In Extremity
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Periarthritis
|
|
|
|
|
subjects affected / exposed
|
2 / 83 (2.41%) |
1 / 82 (1.22%) |
1 / 159 (0.63%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rheumatoid Arthritis
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spinal Osteoarthritis
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Spondylolisthesis
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Synovial Cyst
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 |
Synovitis
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tendon Disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tenosynovitis
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
2 / 159 (1.26%) |
0 / 148 (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 |
Trigger Finger
|
|
|
|
|
subjects affected / exposed
|
3 / 83 (3.61%) |
2 / 82 (2.44%) |
5 / 159 (3.14%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
|
|
Abdominal Wall Abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anal Abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 |
Appendicitis
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
|
|
subjects affected / exposed
|
2 / 83 (2.41%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (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 |
Catheter Site Infection
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 |
Cystitis
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
2 / 148 (1.35%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device Related Infection
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to 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 Foot Infection
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Endocarditis Staphylococcal
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to 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
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
5 / 148 (3.38%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis Norovirus
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Gastroenteritis Viral
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Herpes Zoster
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (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 |
Infected Skin Ulcer
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Influenza
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
2 / 148 (1.35%) |
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 |
Laryngitis
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Localised Infection
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung Abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Medical Device Site Infection
|
|
|
|
|
subjects affected / exposed
|
12 / 83 (14.46%) |
5 / 82 (6.10%) |
5 / 159 (3.14%) |
11 / 148 (7.43%) |
occurrences causally related to treatment / all
|
8 / 12 |
2 / 5 |
3 / 5 |
9 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Paronychia
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
1 / 159 (0.63%) |
0 / 148 (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 |
Pharyngitis
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Post Procedural Infection
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 |
Pyelitis
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
2 / 82 (2.44%) |
2 / 159 (1.26%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory Tract Infection
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Sinusitis
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary Tract Infection
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
3 / 159 (1.89%) |
2 / 148 (1.35%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
2 / 148 (1.35%) |
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 |
Viral Infection
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Metabolism and nutrition disorders
|
|
|
|
|
Acetonaemia
|
|
|
|
|
subjects affected / exposed
|
6 / 83 (7.23%) |
9 / 82 (10.98%) |
9 / 159 (5.66%) |
5 / 148 (3.38%) |
occurrences causally related to treatment / all
|
5 / 8 |
8 / 10 |
9 / 11 |
3 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dehydration
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |
Diabetes Mellitus Inadequate Control
|
|
|
|
|
subjects affected / exposed
|
5 / 83 (6.02%) |
7 / 82 (8.54%) |
10 / 159 (6.29%) |
18 / 148 (12.16%) |
occurrences causally related to treatment / all
|
4 / 7 |
4 / 7 |
3 / 13 |
18 / 25 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic Ketoacidosis
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
1 / 82 (1.22%) |
6 / 159 (3.77%) |
5 / 148 (3.38%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
6 / 7 |
3 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic Ketosis
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
1 / 82 (1.22%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
|
|
subjects affected / exposed
|
9 / 83 (10.84%) |
11 / 82 (13.41%) |
19 / 159 (11.95%) |
20 / 148 (13.51%) |
occurrences causally related to treatment / all
|
6 / 10 |
10 / 11 |
19 / 26 |
24 / 30 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
|
|
subjects affected / exposed
|
13 / 83 (15.66%) |
3 / 82 (3.66%) |
9 / 159 (5.66%) |
18 / 148 (12.16%) |
occurrences causally related to treatment / all
|
3 / 13 |
1 / 3 |
7 / 16 |
6 / 26 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ketosis
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
3 / 82 (3.66%) |
4 / 159 (2.52%) |
1 / 148 (0.68%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 5 |
3 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Obesity
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
1 / 159 (0.63%) |
0 / 148 (0.00%) |
occurrences 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 |
Overweight
|
|
|
|
|
subjects affected / exposed
|
1 / 83 (1.20%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
0 / 148 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Weight Fluctuation
|
|
|
|
|
subjects affected / exposed
|
0 / 83 (0.00%) |
0 / 82 (0.00%) |
0 / 159 (0.00%) |
1 / 148 (0.68%) |
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 |