Serious adverse events
|
S 47445 5 mg - W0-W24 |
S 47445 15 mg - W0-W24 |
S 47445 50 mg - W0-W24 |
Placebo - W0-W24 |
S 47445 5 mg - W24-W52 |
S 47445 15 mg - W24-W52 |
S 47445 50 mg - W24-W52 |
Placebo - W24-W52 |
S 47445 5 mg - W0-W52 |
S 47445 15 mg - W0-W52 |
S 47445 50 mg - W0-W52 |
Placebo - W0-W52 |
Total subjects affected by serious adverse events
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
4 / 129 (3.10%) |
11 / 130 (8.46%) |
5 / 132 (3.79%) |
6 / 129 (4.65%) |
8 / 119 (6.72%) |
16 / 115 (13.91%) |
10 / 115 (8.70%) |
10 / 119 (8.40%) |
11 / 129 (8.53%) |
27 / 130 (20.77%) |
16 / 132 (12.12%) |
17 / 129 (13.18%) |
number of deaths (all causes)
|
0 |
0 |
1 |
1 |
0 |
1 |
1 |
2 |
0 |
1 |
2 |
3 |
number of deaths resulting from adverse events
|
|
|
1 |
1 |
|
1 |
1 |
2 |
|
1 |
2 |
3 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
|
|
|
|
|
|
|
|
|
Basal cell carcinoma
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
1 / 119 (0.84%) |
0 / 115 (0.00%) |
1 / 115 (0.87%) |
0 / 119 (0.00%) |
1 / 129 (0.78%) |
0 / 130 (0.00%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Invasive breast carcinoma
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
1 / 115 (0.87%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oropharyngeal cancer stage IV
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
1 / 115 (0.87%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Prostate cancer
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
1 / 119 (0.84%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
1 / 129 (0.78%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tonsil cancer
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
1 / 115 (0.87%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypertension
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 129 (0.78%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
1 / 129 (0.78%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive crisis
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
1 / 115 (0.87%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
2 / 132 (1.52%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypotension
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 129 (0.78%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
1 / 129 (0.78%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Orthostatic hypotension
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
1 / 119 (0.84%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
1 / 129 (0.78%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
|
|
|
|
|
|
|
|
|
|
Fatigue
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gait disturbance
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
General physical health deterioration
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
1 / 115 (0.87%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Multiple organ dysfunction syndrome
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Non-cardiac chest pain
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
1 / 115 (0.87%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
Cystocele
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
1 / 115 (0.87%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
Bronchitis chronic
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
1 / 115 (0.87%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic obstructive pulmonary disease
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
1 / 115 (0.87%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
1 / 119 (0.84%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary fibrosis
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
1 / 119 (0.84%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
Aggression
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
2 / 130 (1.54%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
1 / 119 (0.84%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
1 / 129 (0.78%) |
2 / 130 (1.54%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Anxiety
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Confusional state
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
1 / 119 (0.84%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
1 / 129 (0.78%) |
0 / 130 (0.00%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Delirium
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
2 / 130 (1.54%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
2 / 130 (1.54%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 3 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Delusion
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Depression
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hallucination, visual
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Major depression
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Middle insomnia
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
1 / 119 (0.84%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
1 / 129 (0.78%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Suicidal ideation
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
1 / 130 (0.77%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
1 / 130 (0.77%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Investigations
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood creatine phosphokinase increased
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
1 / 115 (0.87%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Electrocardiogram abnormal
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
1 / 115 (0.87%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
|
|
|
|
|
|
|
|
|
|
Brain contusion
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 129 (0.78%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
1 / 129 (0.78%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fall
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
3 / 129 (2.33%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
6 / 115 (5.22%) |
1 / 115 (0.87%) |
2 / 119 (1.68%) |
3 / 129 (2.33%) |
7 / 130 (5.38%) |
1 / 132 (0.76%) |
2 / 129 (1.55%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 6 |
0 / 1 |
0 / 2 |
0 / 3 |
0 / 7 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Foot fracture
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
1 / 115 (0.87%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Humerus fracture
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
2 / 115 (1.74%) |
0 / 115 (0.00%) |
1 / 119 (0.84%) |
0 / 129 (0.00%) |
2 / 130 (1.54%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lower limb fracture
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
1 / 115 (0.87%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar vertebral fracture
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
1 / 115 (0.87%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Seroma
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
1 / 115 (0.87%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subarachnoid haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
1 / 129 (0.78%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
Subcutaneous haematoma
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
1 / 115 (0.87%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Traumatic intracranial haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
1 / 115 (0.87%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wrist fracture
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
1 / 119 (0.84%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
Acute coronary syndrome
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute myocardial infarction
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
2 / 115 (1.74%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
2 / 130 (1.54%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Angina pectoris
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic valve incompetence
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Aortic valve sclerosis
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrial fibrillation
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
0 / 119 (0.00%) |
1 / 115 (0.87%) |
0 / 115 (0.00%) |
2 / 119 (1.68%) |
0 / 129 (0.00%) |
2 / 130 (1.54%) |
1 / 132 (0.76%) |
3 / 129 (2.33%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrial flutter
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
1 / 119 (0.84%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac failure
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
1 / 115 (0.87%) |
0 / 115 (0.00%) |
1 / 119 (0.84%) |
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Cardiac failure chronic
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mitral valve incompetence
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mitral valve sclerosis
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myocardial infarction
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myocardial ischaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tricuspid valve incompetence
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
Amimia
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bradykinesia
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cogwheel rigidity
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coma
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
Dementia with Lewy bodies
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dizziness
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
1 / 115 (0.87%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhagic stroke
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
1 / 115 (0.87%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic stroke
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
1 / 115 (0.87%) |
0 / 115 (0.00%) |
1 / 119 (0.84%) |
0 / 129 (0.00%) |
1 / 130 (0.77%) |
1 / 132 (0.76%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Loss of consciousness
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 129 (0.78%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
1 / 119 (0.84%) |
1 / 129 (0.78%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Sciatica
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subdural hygroma
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 129 (0.78%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
1 / 129 (0.78%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Syncope
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 129 (0.78%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
2 / 119 (1.68%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
3 / 129 (2.33%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 4 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subarachnoid haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
alternative dictionary used: MedDRA
19
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 129 (0.78%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
Haemorrhagic anaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
Macular degeneration
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
1 / 119 (0.84%) |
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal discomfort
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
1 / 115 (0.87%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colitis
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
1 / 119 (0.84%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
1 / 129 (0.78%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Constipation
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Duodenal ulcer haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
1 / 115 (0.87%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
1 / 130 (0.77%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dysphagia
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Faecaloma
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
1 / 115 (0.87%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastritis erosive
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
1 / 115 (0.87%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
2 / 132 (1.52%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhoidal haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
1 / 115 (0.87%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Large intestine polyp
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
1 / 119 (0.84%) |
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Melaena
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
Acute kidney injury
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal failure
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
Lumbar spinal stenosis
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 129 (0.78%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
1 / 129 (0.78%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
1 / 115 (0.87%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
|
|
|
|
|
|
|
|
|
|
Diverticulitis
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
1 / 115 (0.87%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Mastoiditis
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
1 / 115 (0.87%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Otitis media
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
1 / 115 (0.87%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 129 (0.78%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
1 / 119 (0.84%) |
1 / 129 (0.78%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
2 / 129 (1.55%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative wound infection
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
1 / 119 (0.84%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Sepsis
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Septic shock
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
1 / 119 (0.84%) |
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
1 / 129 (0.78%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
0 / 130 (0.00%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
1 / 115 (0.87%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Wound infection staphylococcal
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
Dehydration
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
0 / 115 (0.00%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
1 / 130 (0.77%) |
1 / 132 (0.76%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 129 (0.00%) |
1 / 130 (0.77%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
0 / 119 (0.00%) |
1 / 115 (0.87%) |
0 / 115 (0.00%) |
0 / 119 (0.00%) |
0 / 129 (0.00%) |
2 / 130 (1.54%) |
0 / 132 (0.00%) |
0 / 129 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |