Serious adverse events
|
Cohort A: CP-CML R-I |
Cohort B: CP-CML with T315I Mutation |
Cohort C: AP-CML R-I |
Cohort D: AP-CML with T315I Mutation |
Cohort E: BP-CML/Ph+ ALL R-I |
Cohort F: BP-CML or Ph+ ALL with T315I Mutation |
Unassigned AP/CP-CML |
Total subjects affected by serious adverse events
|
|
|
|
|
|
|
|
subjects affected / exposed
|
132 / 203 (65.02%) |
39 / 64 (60.94%) |
44 / 65 (67.69%) |
13 / 18 (72.22%) |
41 / 48 (85.42%) |
37 / 46 (80.43%) |
3 / 5 (60.00%) |
number of deaths (all causes)
|
11 |
5 |
5 |
5 |
20 |
14 |
2 |
number of deaths resulting from adverse events
|
2 |
0 |
0 |
1 |
2 |
1 |
1 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
|
|
|
|
Neoplasm progression
|
|
|
|
|
|
|
|
subjects affected / exposed
|
6 / 203 (2.96%) |
2 / 64 (3.13%) |
7 / 65 (10.77%) |
4 / 18 (22.22%) |
14 / 48 (29.17%) |
8 / 46 (17.39%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
0 / 7 |
0 / 4 |
0 / 14 |
0 / 8 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 2 |
0 / 2 |
0 / 10 |
0 / 5 |
0 / 0 |
Myelodysplastic syndrome
|
|
|
|
|
|
|
|
subjects affected / exposed
|
3 / 203 (1.48%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 1 |
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 |
Malignant melanoma
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
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 |
Malignant pleural effusion
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Basal cell carcinoma
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
2 / 65 (3.08%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
1 / 3 |
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 |
Blast crisis in myelogenous leukaemia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
1 / 18 (5.56%) |
1 / 48 (2.08%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
Squamous cell carcinoma of skin
|
|
|
|
|
|
|
|
subjects affected / exposed
|
3 / 203 (1.48%) |
0 / 64 (0.00%) |
2 / 65 (3.08%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
0 / 3 |
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 |
Chloroma
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Colon cancer
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
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 |
Skin squamous cell carcinoma metastatic
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Large cell lung cancer recurrent
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
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 |
Non-hodgkin's lymphoma
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
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 |
Squamous cell carcinoma
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Vulval cancer
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Central nervous system leukaemia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
1 / 18 (5.56%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Acute lymphocytic leukaemia recurrent
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Pancreatic carcinoma
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Neuroendocrine carcinoma metastatic
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Bowen's disease
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
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 |
Vascular disorders
|
|
|
|
|
|
|
|
Hypertension
|
|
|
|
|
|
|
|
subjects affected / exposed
|
11 / 203 (5.42%) |
0 / 64 (0.00%) |
2 / 65 (3.08%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
8 / 13 |
0 / 0 |
0 / 2 |
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 |
Hypotension
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
1 / 64 (1.56%) |
2 / 65 (3.08%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 2 |
0 / 2 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Deep vein thrombosis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
4 / 203 (1.97%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hot flush
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
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 |
Peripheral ischaemia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
3 / 203 (1.48%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
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 / 1 |
0 / 0 |
Extremity necrosis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
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 |
Hypertensive crisis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
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 |
Embolism venous
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thrombophlebitis superficial
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Peripheral arterial occlusive disease
|
|
|
|
|
|
|
|
subjects affected / exposed
|
10 / 203 (4.93%) |
4 / 64 (6.25%) |
1 / 65 (1.54%) |
1 / 18 (5.56%) |
1 / 48 (2.08%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
8 / 10 |
4 / 5 |
0 / 1 |
1 / 2 |
1 / 2 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery stenosis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
4 / 203 (1.97%) |
3 / 64 (4.69%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
1 / 5 (20.00%) |
occurrences causally related to treatment / all
|
3 / 6 |
2 / 3 |
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 |
Peripheral artery occlusion
|
|
|
|
|
|
|
|
subjects affected / exposed
|
4 / 203 (1.97%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
1 / 18 (5.56%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
3 / 6 |
1 / 1 |
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 |
Peripheral vascular disorder
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
1 / 64 (1.56%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
1 / 1 |
0 / 1 |
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 |
Dry gangrene
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
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 |
Aortic arteriosclerosis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
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 |
Temporal arteritis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Varicose vein
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Vasculitis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 1 |
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 |
Coeliac artery occlusion
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 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 |
Embolism arterial
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Intermittent claudication
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
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 |
General disorders and administration site conditions
|
|
|
|
|
|
|
|
Pyrexia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
5 / 203 (2.46%) |
3 / 64 (4.69%) |
5 / 65 (7.69%) |
2 / 18 (11.11%) |
2 / 48 (4.17%) |
2 / 46 (4.35%) |
1 / 5 (20.00%) |
occurrences causally related to treatment / all
|
1 / 5 |
2 / 3 |
0 / 5 |
0 / 2 |
1 / 2 |
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Non-cardiac chest pain
|
|
|
|
|
|
|
|
subjects affected / exposed
|
4 / 203 (1.97%) |
1 / 64 (1.56%) |
2 / 65 (3.08%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
1 / 1 |
0 / 2 |
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 |
Asthenia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
1 / 18 (5.56%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
1 / 1 |
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 |
Chest pain
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
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 |
Chills
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
2 / 48 (4.17%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
2 / 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 |
Pain
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Systemic inflammatory response syndrome
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
2 / 64 (3.13%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
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 |
Implant site pain
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Impaired healing
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
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 |
Gait disturbance
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Oedema peripheral
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Vascular stent occlusion
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
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 |
Fatigue
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
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 |
Multiple organ dysfunction syndrome
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 / 1 |
0 / 1 |
0 / 0 |
Immune system disorders
|
|
|
|
|
|
|
|
Hypersensitivity
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
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 |
Graft versus host disease in skin
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Anaphylactic reaction
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Anaphylactoid reaction
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Drug hypersensitivity
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Social circumstances
|
|
|
|
|
|
|
|
Immobile
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Reproductive system and breast disorders
|
|
|
|
|
|
|
|
Prostatic obstruction
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Prostatitis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Haemorrhagic ovarian cyst
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
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 |
Ovarian cyst
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
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 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
|
|
|
|
Dyspnoea
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
3 / 64 (4.69%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
1 / 5 (20.00%) |
occurrences causally related to treatment / all
|
2 / 3 |
2 / 3 |
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 |
Hypoxia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
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 |
Pneumothorax
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Pulmonary embolism
|
|
|
|
|
|
|
|
subjects affected / exposed
|
3 / 203 (1.48%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
3 / 48 (6.25%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
2 / 3 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
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 |
Pleural effusion
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
1 / 64 (1.56%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
1 / 46 (2.17%) |
1 / 5 (20.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
0 / 1 |
0 / 0 |
1 / 1 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory failure
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
2 / 65 (3.08%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
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 |
Chronic obstructive pulmonary disease
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
2 / 46 (4.35%) |
1 / 5 (20.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dyspnoea exertional
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Pleuritic pain
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Pulmonary hypertension
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
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 |
Pneumonitis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
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 |
Lung disorder
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
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 |
Psychiatric disorders
|
|
|
|
|
|
|
|
Confusional state
|
|
|
|
|
|
|
|
subjects affected / exposed
|
3 / 203 (1.48%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
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 |
Mental status changes
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
2 / 46 (4.35%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
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 |
Delirium
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Product issues
|
|
|
|
|
|
|
|
Device dislocation
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
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 |
Investigations
|
|
|
|
|
|
|
|
Lipase increased
|
|
|
|
|
|
|
|
subjects affected / exposed
|
4 / 203 (1.97%) |
3 / 64 (4.69%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
4 / 4 |
3 / 3 |
1 / 1 |
0 / 0 |
1 / 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 |
Platelet count decreased
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
0 / 64 (0.00%) |
2 / 65 (3.08%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
2 / 6 |
0 / 0 |
2 / 2 |
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 |
Alanine aminotransferase increased
|
|
|
|
|
|
|
|
subjects affected / exposed
|
3 / 203 (1.48%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
2 / 3 |
0 / 0 |
1 / 1 |
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 |
Neutrophil count decreased
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
1 / 1 |
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 |
Blood alkaline phosphatase increased
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
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 |
Ejection fraction decreased
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
2 / 48 (4.17%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
2 / 2 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gamma-glutamyltransferase increased
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
2 / 65 (3.08%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 2 |
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 |
Blood bilirubin increased
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
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 |
Aspartate aminotransferase increased
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
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 |
Urine analysis abnormal
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 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 |
Hepatic enzyme increased
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
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 |
International normalised ratio increased
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Liver function test increased
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
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 |
Blood potassium increased
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
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 |
Haemoglobin decreased
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
JC polyomavirus test positive
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
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 |
Injury, poisoning and procedural complications
|
|
|
|
|
|
|
|
Subarachnoid haemorrhage
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
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 |
Concussion
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
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 |
Peripancreatic fluid collection
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
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 |
Procedural vomiting
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Fall
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
1 / 18 (5.56%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
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 |
Subdural haematoma
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
0 / 64 (0.00%) |
2 / 65 (3.08%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 2 |
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 |
Post procedural haematoma
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 2 |
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 |
Post procedural haemorrhage
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
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 |
Procedural pain
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
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 |
Traumatic intracranial haemorrhage
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
1 / 18 (5.56%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 / 1 |
0 / 0 |
Pneumonitis chemical
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Peripheral artery restenosis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
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 |
Head injury
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Humerus fracture
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Spinal column injury
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Wound dehiscence
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
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 |
Wrist fracture
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Cardiac disorders
|
|
|
|
|
|
|
|
Atrial fibrillation
|
|
|
|
|
|
|
|
subjects affected / exposed
|
11 / 203 (5.42%) |
4 / 64 (6.25%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
3 / 48 (6.25%) |
2 / 46 (4.35%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
9 / 21 |
0 / 4 |
0 / 0 |
0 / 0 |
1 / 3 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac failure congestive
|
|
|
|
|
|
|
|
subjects affected / exposed
|
5 / 203 (2.46%) |
3 / 64 (4.69%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
4 / 5 |
2 / 4 |
1 / 2 |
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Coronary artery disease
|
|
|
|
|
|
|
|
subjects affected / exposed
|
4 / 203 (1.97%) |
6 / 64 (9.38%) |
1 / 65 (1.54%) |
1 / 18 (5.56%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
2 / 4 |
5 / 7 |
1 / 1 |
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 |
Acute myocardial infarction
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
1 / 64 (1.56%) |
1 / 65 (1.54%) |
2 / 18 (11.11%) |
2 / 48 (4.17%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 5 |
1 / 2 |
1 / 1 |
1 / 2 |
2 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Angina pectoris
|
|
|
|
|
|
|
|
subjects affected / exposed
|
10 / 203 (4.93%) |
4 / 64 (6.25%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
8 / 13 |
3 / 5 |
0 / 0 |
0 / 0 |
1 / 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 |
Cardiac arrest
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
Coronary artery stenosis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
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 |
Atrial tachycardia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
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 |
Pericardial effusion
|
|
|
|
|
|
|
|
subjects affected / exposed
|
3 / 203 (1.48%) |
1 / 64 (1.56%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
3 / 3 |
1 / 1 |
1 / 1 |
0 / 0 |
1 / 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 |
Sinus tachycardia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Acute coronary syndrome
|
|
|
|
|
|
|
|
subjects affected / exposed
|
3 / 203 (1.48%) |
3 / 64 (4.69%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
1 / 5 (20.00%) |
occurrences causally related to treatment / all
|
3 / 3 |
3 / 3 |
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 |
Cardiopulmonary failure
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
1 / 18 (5.56%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 / 1 |
0 / 0 |
Cardiac failure
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
1 / 18 (5.56%) |
3 / 48 (6.25%) |
0 / 46 (0.00%) |
1 / 5 (20.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
1 / 1 |
1 / 3 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrial flutter
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Atrioventricular block complete
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Cardiac tamponade
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Cardiogenic shock
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Pericarditis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Right ventricular failure
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Tachycardia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
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 |
Coronary artery occlusion
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
1 / 64 (1.56%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
1 / 1 |
0 / 1 |
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 |
Acute left ventricular failure
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
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 |
Angina unstable
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
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 |
Aortic valve stenosis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
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 |
Arrhythmia supraventricular
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
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 |
Arteriosclerosis coronary artery
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Arteriospasm coronary
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
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 |
Bradycardia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
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 |
Cardiac Discomfort
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
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 |
Cardiac failure acute
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
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 |
Cardio-respiratory arrest
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Congestive cardiomyopathy
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
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 |
Dressler's syndrome
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
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 |
Ischaemic cardiomyopathy
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
1 / 1 |
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 |
Left ventricular dysfunction
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Mitral valve incompetence
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
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 |
Sinus node dysfunction
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Ventricular tachycardia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
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 |
Cardiac failure chronic
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
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 |
Bundle branch block right
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Left ventricular failure
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 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 |
Myocardial infarction
|
|
|
|
|
|
|
|
subjects affected / exposed
|
3 / 203 (1.48%) |
4 / 64 (6.25%) |
2 / 65 (3.08%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
3 / 5 |
0 / 2 |
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 |
Nervous system disorders
|
|
|
|
|
|
|
|
Cerebrovascular accident
|
|
|
|
|
|
|
|
subjects affected / exposed
|
5 / 203 (2.46%) |
4 / 64 (6.25%) |
1 / 65 (1.54%) |
1 / 18 (5.56%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
2 / 7 |
1 / 4 |
1 / 1 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Headache
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
1 / 18 (5.56%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
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 |
Transient ischaemic attack
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
2 / 64 (3.13%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 2 |
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 |
Ataxia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Cerebral artery stenosis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
2 / 64 (3.13%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
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 |
Cerebral infarction
|
|
|
|
|
|
|
|
subjects affected / exposed
|
5 / 203 (2.46%) |
3 / 64 (4.69%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
4 / 5 |
3 / 4 |
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 |
Haemorrhagic cerebral infarction
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhagic transformation stroke
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
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 |
IVth nerve paralysis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
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 |
Spinal cord compression
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Cerebellar infarction
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
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 |
Cerebral haemorrhage
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
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 |
Cerebral ischaemia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
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 / 1 |
0 / 0 |
Dizziness
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 4 |
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 |
Migraine
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
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 |
Somnolence
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
1 / 5 (20.00%) |
occurrences causally related to treatment / all
|
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 |
Syncope
|
|
|
|
|
|
|
|
subjects affected / exposed
|
3 / 203 (1.48%) |
1 / 64 (1.56%) |
2 / 65 (3.08%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
2 / 3 |
0 / 1 |
1 / 2 |
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 |
Haemorrhage intracranial
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 / 1 |
0 / 0 |
0 / 0 |
Brain oedema
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Loss of consciousness
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Paraesthesia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Status epilepticus
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Dementia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
1 / 18 (5.56%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 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 |
Facial Paralysis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
1 / 1 |
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 |
IIIrd nerve paralysis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
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 |
Neuropathy peripheral
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
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 |
Carotid artery stenosis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
5 / 203 (2.46%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
2 / 5 |
1 / 1 |
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 |
Cerebrovascular disorder
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
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 |
Encephalopathy
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Hypoaesthesia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
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 |
Intracranial aneurysm
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Lacunar infarction
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
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 |
Memory impairment
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Sciatica
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Seizure
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Carotid artery occlusion
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
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 |
Blood and lymphatic system disorders
|
|
|
|
|
|
|
|
Anaemia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
7 / 203 (3.45%) |
0 / 64 (0.00%) |
4 / 65 (6.15%) |
0 / 18 (0.00%) |
2 / 48 (4.17%) |
2 / 46 (4.35%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
2 / 9 |
0 / 0 |
1 / 4 |
0 / 0 |
1 / 3 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Febrile neutropenia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
1 / 18 (5.56%) |
5 / 48 (10.42%) |
5 / 46 (10.87%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 2 |
1 / 1 |
1 / 6 |
1 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
1 / 18 (5.56%) |
2 / 48 (4.17%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
1 / 1 |
1 / 2 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Splenic infarction
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Hyperviscosity syndrome
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 / 1 |
0 / 0 |
0 / 0 |
Hyperleukocytosis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Lymphadenopathy
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Neutropenia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
2 / 46 (4.35%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
1 / 64 (1.56%) |
4 / 65 (6.15%) |
0 / 18 (0.00%) |
2 / 48 (4.17%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 4 |
0 / 0 |
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 |
Ear and labyrinth disorders
|
|
|
|
|
|
|
|
Vertigo positional
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Vertigo
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
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 |
Eye disorders
|
|
|
|
|
|
|
|
Retinal vein occlusion
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 1 |
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 |
Cataract
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
1 / 1 |
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 |
Cystoid macular oedema
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
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 |
Retinal artery occlusion
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
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 |
Retinal vein thrombosis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
1 / 18 (5.56%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
1 / 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 |
Ulcerative keratitis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Vision blurred
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
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 |
Macular fibrosis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
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 |
Gastrointestinal disorders
|
|
|
|
|
|
|
|
Pancreatitis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
10 / 203 (4.93%) |
4 / 64 (6.25%) |
3 / 65 (4.62%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
9 / 10 |
4 / 5 |
3 / 4 |
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 |
Abdominal pain
|
|
|
|
|
|
|
|
subjects affected / exposed
|
7 / 203 (3.45%) |
1 / 64 (1.56%) |
4 / 65 (6.15%) |
1 / 18 (5.56%) |
4 / 48 (8.33%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
6 / 9 |
1 / 1 |
0 / 4 |
0 / 1 |
1 / 5 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Constipation
|
|
|
|
|
|
|
|
subjects affected / exposed
|
3 / 203 (1.48%) |
1 / 64 (1.56%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
3 / 3 |
0 / 1 |
1 / 1 |
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 |
Diarrhoea
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
1 / 64 (1.56%) |
1 / 65 (1.54%) |
1 / 18 (5.56%) |
1 / 48 (2.08%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
0 / 1 |
1 / 1 |
0 / 1 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastritis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
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 |
Vomiting
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
2 / 48 (4.17%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
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 |
Colitis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 4 |
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 |
Hiatus hernia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Ileus
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Nausea
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Oesophagitis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Haemorrhoidal haemorrhage
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
1 / 5 (20.00%) |
occurrences causally related to treatment / all
|
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 |
Ascites
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
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 |
Rectal haemorrhage
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
1 / 5 (20.00%) |
occurrences causally related to treatment / all
|
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 |
Retroperitoneal haematoma
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
2 / 65 (3.08%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
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 |
Gastrointestinal haemorrhage
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
2 / 46 (4.35%) |
1 / 5 (20.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
Abdominal distension
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Acute abdomen
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Dysphagia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Gastric haemorrhage
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Gastritis haemorrhagic
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
Stomatitis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Appendicitis Noninfective
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Colitis Ischaemic
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
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 |
Faecaloma
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
1 / 5 (20.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Fistula of small intestine
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Gastric ulcer haemorrhage
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Inguinal hernia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Large intestinal obstruction
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
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 |
Small intestinal obstruction
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 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 |
Upper gastrointestinal haemorrhage
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
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 |
Gastrooesophageal reflux disease
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
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 |
Peritoneal haemorrhage
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
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 |
Mesenteric arterial occlusion
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
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 |
Pancreatitis acute
|
|
|
|
|
|
|
|
subjects affected / exposed
|
5 / 203 (2.46%) |
1 / 64 (1.56%) |
2 / 65 (3.08%) |
0 / 18 (0.00%) |
2 / 48 (4.17%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 1 |
0 / 2 |
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 |
Hepatobiliary disorders
|
|
|
|
|
|
|
|
Bile duct stone
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
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 |
Cholangitis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
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 |
Cholelithiasis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
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 |
Cholecystitis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
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 |
Cholecystitis acute
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
1 / 64 (1.56%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
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 |
Portal vein thrombosis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Non-alcoholic steatohepatitis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
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 |
Venoocclusive liver disease
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
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 |
Biliary dilatation
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
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 |
Gallbladder obstruction
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
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 |
Hyperbilirubinaemia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
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 |
Skin and subcutaneous tissue disorders
|
|
|
|
|
|
|
|
Angioedema
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
1 / 18 (5.56%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Erythema
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
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 |
Erythema multiforme
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
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 |
Hyperkeratosis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
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 |
Skin ulcer
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
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 |
Acute febrile neutrophilic dermatosis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
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 |
Dermatitis exfoliative generalised
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Skin swelling
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Diabetic foot
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
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 |
Mucocutaneous haemorrhage
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
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 |
Rash erythematous
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Rash maculo-papular
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
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 |
Renal and urinary disorders
|
|
|
|
|
|
|
|
Renal failure
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
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 |
Nephrolithiasis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
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 |
Acute kidney injury
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
2 / 64 (3.13%) |
2 / 65 (3.08%) |
0 / 18 (0.00%) |
3 / 48 (6.25%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
1 / 2 |
0 / 0 |
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal artery stenosis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
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 |
Haematuria
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
1 / 5 (20.00%) |
occurrences causally related to treatment / all
|
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 |
Urinary retention
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
1 / 5 (20.00%) |
occurrences causally related to treatment / all
|
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 |
Dysuria
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Endocrine disorders
|
|
|
|
|
|
|
|
Thyroid mass
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
1 / 18 (5.56%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Musculoskeletal and connective tissue disorders
|
|
|
|
|
|
|
|
Arthralgia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
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 |
Back pain
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
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 |
Flank pain
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
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 |
Myalgia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
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 |
Spinal osteoarthritis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Lumbar spinal stenosis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
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 |
Bone pain
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
2 / 48 (4.17%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
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 |
Musculoskeletal pain
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Spinal column stenosis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Osteoarthritis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
1 / 18 (5.56%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
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 |
Intervertebral disc protrusion
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
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 |
Infections and infestations
|
|
|
|
|
|
|
|
Pneumonia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
10 / 203 (4.93%) |
5 / 64 (7.81%) |
8 / 65 (12.31%) |
1 / 18 (5.56%) |
4 / 48 (8.33%) |
5 / 46 (10.87%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
2 / 13 |
0 / 8 |
1 / 9 |
0 / 1 |
0 / 6 |
1 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 2 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
4 / 203 (1.97%) |
1 / 64 (1.56%) |
2 / 65 (3.08%) |
1 / 18 (5.56%) |
2 / 48 (4.17%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
2 / 4 |
0 / 1 |
0 / 2 |
0 / 1 |
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 |
Sepsis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
1 / 64 (1.56%) |
2 / 65 (3.08%) |
1 / 18 (5.56%) |
2 / 48 (4.17%) |
2 / 46 (4.35%) |
1 / 5 (20.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 2 |
0 / 2 |
0 / 1 |
1 / 2 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
0 / 1 |
0 / 0 |
Upper respiratory tract infection
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
1 / 1 |
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 |
Urinary tract infection
|
|
|
|
|
|
|
|
subjects affected / exposed
|
5 / 203 (2.46%) |
2 / 64 (3.13%) |
0 / 65 (0.00%) |
1 / 18 (5.56%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 2 |
0 / 0 |
1 / 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 |
Bacterial infection
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
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 |
Bronchitis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Diverticulitis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
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 |
Herpes oesophagitis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Osteomyelitis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
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 |
Respiratory syncytial virus infection
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
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 |
Wound infection
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
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 |
Bacteraemia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
1 / 18 (5.56%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
1 / 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 |
Appendicitis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
2 / 65 (3.08%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
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 |
Breast cellulitis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
1 / 18 (5.56%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Clostridium difficile colitis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
3 / 203 (1.48%) |
0 / 64 (0.00%) |
2 / 65 (3.08%) |
0 / 18 (0.00%) |
2 / 48 (4.17%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 2 |
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 |
Infection
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
2 / 65 (3.08%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 2 |
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 |
Localised infection
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
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 |
Lung infection
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
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 |
Pharyngitis streptococcal
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
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 |
Pneumonia fungal
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
1 / 18 (5.56%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary tuberculosis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
1 / 18 (5.56%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Respiratory tract infection
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
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 |
Septic shock
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
2 / 46 (4.35%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
Splenic abscess
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
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 |
Klebsiella sepsis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
2 / 46 (4.35%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
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 |
Catheter site cellulitis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Gastroenteritis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
2 / 48 (4.17%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 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 |
Haematoma infection
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Otitis externa
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Pneumonia respiratory syncytial viral
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Post procedural infection
|
|
|
|
|
|
|
|
subjects affected / exposed
|
2 / 203 (0.99%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
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 |
Abdominal sepsis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Arthritis bacterial
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Arthritis viral
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Cholecystitis infective
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
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 |
Clostridium difficile infection
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Genital infection bacterial
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Otitis media chronic
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Peritonitis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Pneumonia mycoplasmal
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Pyelonephritis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Pyelonephritis acute
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Systemic infection
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
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 |
Viral infection
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
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 |
Wound infection staphylococcal
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Pneumonia staphylococcal
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
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 |
Gangrene
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
1 / 18 (5.56%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 2 |
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 |
Gastroenteritis norovirus
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
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 |
Kidney infection
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
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 |
Urosepsis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
1 / 18 (5.56%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 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 |
Oesophageal candidiasis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
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 |
Atypical pneumonia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Device related sepsis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Infectious colitis
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 / 1 |
0 / 0 |
0 / 0 |
Pneumonia influenzal
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Postoperative wound infection
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Staphylococcal bacteraemia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Pneumocystis jirovecii pneumonia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
|
|
|
|
|
Hyponatraemia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
4 / 203 (1.97%) |
1 / 64 (1.56%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
2 / 5 |
0 / 1 |
0 / 1 |
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 |
Dehydration
|
|
|
|
|
|
|
|
subjects affected / exposed
|
4 / 203 (1.97%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
2 / 48 (4.17%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 2 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Diabetes mellitus
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
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 |
Hyperkalaemia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Electrolyte imbalance
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
1 / 65 (1.54%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
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 |
Tumour lysis syndrome
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
1 / 18 (5.56%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 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 |
Failure to thrive
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Fluid overload
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
1 / 48 (2.08%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Fluid retention
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperuricaemia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
1 / 46 (2.17%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
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 |
Hypercalcaemia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
1 / 203 (0.49%) |
0 / 64 (0.00%) |
0 / 65 (0.00%) |
1 / 18 (5.56%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
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 |
Hyperglycaemia
|
|
|
|
|
|
|
|
subjects affected / exposed
|
0 / 203 (0.00%) |
1 / 64 (1.56%) |
0 / 65 (0.00%) |
0 / 18 (0.00%) |
0 / 48 (0.00%) |
0 / 46 (0.00%) |
0 / 5 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
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 |