Serious adverse events
|
Part A: Remdesivir (RDV) for 5 Days |
Part A: Remdesivir for 10 Days |
Part B: Remdesivir for 10 Days |
Part B: Remdesivir for 10 Days (Extension Group) |
Total subjects affected by serious adverse events
|
|
|
|
|
subjects affected / exposed
|
43 / 200 (21.50%) |
68 / 197 (34.52%) |
362 / 844 (42.89%) |
851 / 3597 (23.66%) |
number of deaths (all causes)
|
25 |
28 |
213 |
422 |
number of deaths resulting from adverse events
|
|
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
|
Bone cancer
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Vascular disorders
|
|
|
|
|
Hypotension
|
|
|
|
|
subjects affected / exposed
|
1 / 200 (0.50%) |
3 / 197 (1.52%) |
23 / 844 (2.73%) |
53 / 3597 (1.47%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 23 |
0 / 54 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 9 |
Shock
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
7 / 844 (0.83%) |
11 / 3597 (0.31%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 7 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 3 |
Deep vein thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
6 / 844 (0.71%) |
3 / 3597 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Shock haemorrhagic
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
1 / 197 (0.51%) |
2 / 844 (0.24%) |
4 / 3597 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Distributive shock
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
3 / 3597 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Hypovolaemic shock
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
3 / 3597 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Arterial thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Circulatory collapse
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
2 / 844 (0.24%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
Hypertension
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Jugular vein thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
2 / 3597 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral ischaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dry gangrene
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Embolism
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemodynamic instability
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
1 / 197 (0.51%) |
0 / 844 (0.00%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
Thrombophlebitis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Thrombosis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
1 / 197 (0.51%) |
0 / 844 (0.00%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
|
|
Multiple organ dysfunction syndrome
|
|
|
|
|
subjects affected / exposed
|
2 / 200 (1.00%) |
4 / 197 (2.03%) |
27 / 844 (3.20%) |
32 / 3597 (0.89%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 27 |
0 / 32 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 25 |
0 / 30 |
Pyrexia
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
1 / 197 (0.51%) |
4 / 844 (0.47%) |
5 / 3597 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Death
|
|
|
|
|
subjects affected / exposed
|
1 / 200 (0.50%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
2 / 3597 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 2 |
Brain death
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
2 / 3597 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
Chest pain
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperthermia malignant
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
2 / 844 (0.24%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Asthenia
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
1 / 197 (0.51%) |
0 / 844 (0.00%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fatigue
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperthermia
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Multi-organ disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Oedema
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pelvic mass
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Procedural failure
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
|
|
Cytokine release syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
2 / 844 (0.24%) |
5 / 3597 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Cytokine storm
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
2 / 3597 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Drug hypersensitivity
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypersensitivity
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Social circumstances
|
|
|
|
|
Social stay hospitalisation
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
|
|
Priapism
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
|
Respiratory failure
|
|
|
|
|
subjects affected / exposed
|
6 / 200 (3.00%) |
10 / 197 (5.08%) |
59 / 844 (6.99%) |
254 / 3597 (7.06%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 10 |
0 / 59 |
0 / 255 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 3 |
0 / 38 |
0 / 123 |
Acute respiratory failure
|
|
|
|
|
subjects affected / exposed
|
10 / 200 (5.00%) |
18 / 197 (9.14%) |
36 / 844 (4.27%) |
121 / 3597 (3.36%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 20 |
0 / 36 |
0 / 121 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 6 |
0 / 30 |
0 / 60 |
Hypoxia
|
|
|
|
|
subjects affected / exposed
|
2 / 200 (1.00%) |
4 / 197 (2.03%) |
14 / 844 (1.66%) |
78 / 3597 (2.17%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 14 |
0 / 79 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
0 / 17 |
Respiratory distress
|
|
|
|
|
subjects affected / exposed
|
3 / 200 (1.50%) |
5 / 197 (2.54%) |
14 / 844 (1.66%) |
71 / 3597 (1.97%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
0 / 14 |
0 / 71 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 6 |
0 / 18 |
Acute respiratory distress syndrome
|
|
|
|
|
subjects affected / exposed
|
1 / 200 (0.50%) |
4 / 197 (2.03%) |
23 / 844 (2.73%) |
42 / 3597 (1.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
1 / 23 |
0 / 42 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
1 / 19 |
0 / 25 |
Pulmonary embolism
|
|
|
|
|
subjects affected / exposed
|
1 / 200 (0.50%) |
4 / 197 (2.03%) |
9 / 844 (1.07%) |
32 / 3597 (0.89%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
0 / 9 |
0 / 32 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
0 / 3 |
Pneumothorax
|
|
|
|
|
subjects affected / exposed
|
2 / 200 (1.00%) |
4 / 197 (2.03%) |
6 / 844 (0.71%) |
25 / 3597 (0.70%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
0 / 6 |
0 / 25 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 2 |
0 / 4 |
Dyspnoea
|
|
|
|
|
subjects affected / exposed
|
4 / 200 (2.00%) |
1 / 197 (0.51%) |
3 / 844 (0.36%) |
26 / 3597 (0.72%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 3 |
0 / 26 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Respiratory disorder
|
|
|
|
|
subjects affected / exposed
|
1 / 200 (0.50%) |
1 / 197 (0.51%) |
2 / 844 (0.24%) |
22 / 3597 (0.61%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
0 / 22 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 9 |
Pneumomediastinum
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
2 / 844 (0.24%) |
3 / 3597 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Respiratory arrest
|
|
|
|
|
subjects affected / exposed
|
1 / 200 (0.50%) |
0 / 197 (0.00%) |
2 / 844 (0.24%) |
2 / 3597 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Pneumonia aspiration
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
3 / 3597 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Respiratory acidosis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
2 / 3597 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Stridor
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
3 / 844 (0.36%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemoptysis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
1 / 197 (0.51%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypercapnia
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
2 / 844 (0.24%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary oedema
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
2 / 3597 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory tract haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
2 / 844 (0.24%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Aspiration
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bronchiectasis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chronic obstructive pulmonary disease
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Emphysema
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemothorax
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperoxia
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Interstitial lung disease
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lung opacity
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pharyngeal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pickwickian syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonitis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Pneumothorax spontaneous
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary thrombosis
|
|
|
|
|
subjects affected / exposed
|
1 / 200 (0.50%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory gas exchange disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Respiratory tract oedema
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tachypnoea
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thoracic haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
|
|
Mental status changes
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
2 / 844 (0.24%) |
10 / 3597 (0.28%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Delirium
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
2 / 844 (0.24%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Confusional state
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Paranoia
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Product issues
|
|
|
|
|
Device dislocation
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Investigations
|
|
|
|
|
Transaminases increased
|
|
|
|
|
subjects affected / exposed
|
3 / 200 (1.50%) |
2 / 197 (1.02%) |
6 / 844 (0.71%) |
3 / 3597 (0.08%) |
occurrences causally related to treatment / all
|
3 / 3 |
2 / 2 |
4 / 6 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood creatinine increased
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
5 / 844 (0.59%) |
2 / 3597 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Creatinine renal clearance decreased
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
2 / 844 (0.24%) |
4 / 3597 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oxygen saturation decreased
|
|
|
|
|
subjects affected / exposed
|
1 / 200 (0.50%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
5 / 3597 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
Aspartate aminotransferase increased
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
4 / 3597 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
2 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Alanine aminotransferase increased
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
3 / 3597 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Liver function test increased
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
1 / 197 (0.51%) |
0 / 844 (0.00%) |
2 / 3597 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Glomerular filtration rate decreased
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
1 / 197 (0.51%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haemoglobin decreased
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic enzyme increased
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
1 / 197 (0.51%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oxygen consumption increased
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Oxygen saturation abnormal
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
2 / 844 (0.24%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Troponin increased
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
2 / 3597 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bacterial test positive
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood alkaline phosphatase increased
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood bilirubin increased
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood pressure abnormal
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coma scale abnormal
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Creatinine renal clearance abnormal
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
General physical condition abnormal
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Myocardial necrosis marker increased
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Platelet count decreased
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urine output decreased
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
|
|
Barotrauma
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
3 / 3597 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Endotracheal intubation complication
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
2 / 844 (0.24%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fall
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hip fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subdural haematoma
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Subdural haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
|
|
Cardiac arrest
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
2 / 197 (1.02%) |
15 / 844 (1.78%) |
34 / 3597 (0.95%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 15 |
0 / 35 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 11 |
0 / 25 |
Atrial fibrillation
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
10 / 844 (1.18%) |
12 / 3597 (0.33%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 10 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
Cardio-respiratory arrest
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
2 / 844 (0.24%) |
11 / 3597 (0.31%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 11 |
Acute myocardial infarction
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
1 / 197 (0.51%) |
4 / 844 (0.47%) |
2 / 3597 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
Arrhythmia
|
|
|
|
|
subjects affected / exposed
|
1 / 200 (0.50%) |
0 / 197 (0.00%) |
3 / 844 (0.36%) |
3 / 3597 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
Pulseless electrical activity
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
2 / 844 (0.24%) |
5 / 3597 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
Bradycardia
|
|
|
|
|
subjects affected / exposed
|
1 / 200 (0.50%) |
0 / 197 (0.00%) |
2 / 844 (0.24%) |
3 / 3597 (0.08%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 2 |
Cardiogenic shock
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
5 / 3597 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 3 |
Myocardial infarction
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
4 / 3597 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
Cardiac failure
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
2 / 844 (0.24%) |
2 / 3597 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 1 |
Supraventricular tachycardia
|
|
|
|
|
subjects affected / exposed
|
1 / 200 (0.50%) |
0 / 197 (0.00%) |
2 / 844 (0.24%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Ventricular tachycardia
|
|
|
|
|
subjects affected / exposed
|
1 / 200 (0.50%) |
0 / 197 (0.00%) |
2 / 844 (0.24%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
0 / 0 |
Atrioventricular block complete
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
3 / 3597 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiomyopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
2 / 844 (0.24%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Cardiac failure acute
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
1 / 197 (0.51%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Myocardial ischaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Right ventricular dysfunction
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
2 / 844 (0.24%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Angina pectoris
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrial flutter
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Atrioventricular block second degree
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac failure congestive
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Cyanosis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pericarditis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Right ventricular failure
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Stress cardiomyopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular arrhythmia
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Ventricular fibrillation
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Nervous system disorders
|
|
|
|
|
Cerebrovascular accident
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
4 / 844 (0.47%) |
7 / 3597 (0.19%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
Cerebral haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
3 / 844 (0.36%) |
4 / 3597 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 2 |
Haemorrhage intracranial
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
4 / 844 (0.47%) |
2 / 3597 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 0 |
Cerebral infarction
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
2 / 844 (0.24%) |
3 / 3597 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Brain injury
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
3 / 844 (0.36%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 1 |
Ischaemic stroke
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
4 / 3597 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
Seizure
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
3 / 3597 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Encephalopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
2 / 3597 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Autonomic nervous system imbalance
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Brain oedema
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebellar infarction
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral microhaemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
1 / 197 (0.51%) |
0 / 844 (0.00%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coma
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Dizziness
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Embolic stroke
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Facial paralysis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Guillain-Barre syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Headache
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypoxic-ischaemic encephalopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Iiird nerve disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lethargy
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Nervous system disorder
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Posterior reversible encephalopathy ~ syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Seizure like phenomena
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Syncope
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thrombotic stroke
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Toxic encephalopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
|
|
Anaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
1 / 197 (0.51%) |
4 / 844 (0.47%) |
9 / 3597 (0.25%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 4 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Disseminated intravascular coagulation
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
3 / 3597 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Blood loss anaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
2 / 3597 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bicytopenia
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Bone marrow failure
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Coagulopathy
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Leukocytosis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Neutropenia
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
1 / 197 (0.51%) |
0 / 844 (0.00%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Splenic infarction
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Thrombocytopenia
|
|
|
|
|
subjects affected / exposed
|
1 / 200 (0.50%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
|
|
Gastrointestinal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
1 / 197 (0.51%) |
1 / 844 (0.12%) |
3 / 3597 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 1 |
Intestinal ischaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
3 / 844 (0.36%) |
2 / 3597 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 1 |
Retroperitoneal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
2 / 844 (0.24%) |
2 / 3597 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Dysphagia
|
|
|
|
|
subjects affected / exposed
|
1 / 200 (0.50%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
2 / 3597 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haematemesis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
3 / 3597 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Lower gastrointestinal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
2 / 844 (0.24%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Retroperitoneal haematoma
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
2 / 844 (0.24%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Colitis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
2 / 3597 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal wall haematoma
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diverticular perforation
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Duodenal ulcer
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Gastric perforation
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ileus
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ileus paralytic
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal pseudo-obstruction
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Intra-abdominal haematoma
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis acute
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis necrotising
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumatosis intestinalis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Rectal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Stomatitis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Vomiting
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
|
|
Hepatic failure
|
|
|
|
|
subjects affected / exposed
|
1 / 200 (0.50%) |
0 / 197 (0.00%) |
2 / 844 (0.24%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Acute hepatic failure
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
2 / 3597 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperbilirubinaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypertransaminasaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
1 / 197 (0.51%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic hepatitis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Biliary colic
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
|
|
Subcutaneous emphysema
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
2 / 844 (0.24%) |
4 / 3597 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Decubitus ulcer
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Drug eruption
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
|
|
Acute kidney injury
|
|
|
|
|
subjects affected / exposed
|
2 / 200 (1.00%) |
3 / 197 (1.52%) |
50 / 844 (5.92%) |
69 / 3597 (1.92%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
2 / 50 |
2 / 69 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 6 |
0 / 5 |
Renal failure
|
|
|
|
|
subjects affected / exposed
|
1 / 200 (0.50%) |
1 / 197 (0.51%) |
13 / 844 (1.54%) |
17 / 3597 (0.47%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 13 |
1 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 5 |
0 / 1 |
Renal impairment
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
4 / 844 (0.47%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
Anuria
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Azotaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Renal tubular necrosis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary retention
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
|
|
Rhabdomyolysis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
4 / 844 (0.47%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Compartment syndrome
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
2 / 844 (0.24%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Arthritis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Chest wall haematoma
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Haematoma muscle
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Muscle haemorrhage
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal chest pain
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
|
|
Septic shock
|
|
|
|
|
subjects affected / exposed
|
2 / 200 (1.00%) |
5 / 197 (2.54%) |
27 / 844 (3.20%) |
52 / 3597 (1.45%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
0 / 27 |
0 / 52 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 10 |
0 / 24 |
Sepsis
|
|
|
|
|
subjects affected / exposed
|
2 / 200 (1.00%) |
1 / 197 (0.51%) |
11 / 844 (1.30%) |
34 / 3597 (0.95%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 11 |
0 / 34 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 5 |
0 / 14 |
Corona virus infection
|
|
|
|
|
subjects affected / exposed
|
8 / 200 (4.00%) |
10 / 197 (5.08%) |
5 / 844 (0.59%) |
22 / 3597 (0.61%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 10 |
0 / 5 |
0 / 22 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 5 |
0 / 11 |
Pneumonia viral
|
|
|
|
|
subjects affected / exposed
|
3 / 200 (1.50%) |
2 / 197 (1.02%) |
18 / 844 (2.13%) |
22 / 3597 (0.61%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 18 |
0 / 22 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 12 |
0 / 13 |
Pneumonia
|
|
|
|
|
subjects affected / exposed
|
2 / 200 (1.00%) |
0 / 197 (0.00%) |
6 / 844 (0.71%) |
24 / 3597 (0.67%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 6 |
0 / 25 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 4 |
0 / 14 |
Pneumonia bacterial
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
7 / 844 (0.83%) |
4 / 3597 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 2 |
Bacteraemia
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
7 / 844 (0.83%) |
3 / 3597 (0.08%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia pseudomonal
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
3 / 844 (0.36%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Abdominal sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Bronchopulmonary aspergillosis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Pulmonary sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal bacteraemia
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Superinfection
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Abdominal abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Citrobacter bacteraemia
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Device related infection
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Endocarditis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Enterococcal bacteraemia
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Escherichia bacteraemia
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Fungaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Fungal infection
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Gangrene
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia haemophilus
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia staphylococcal
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Pseudomonal bacteraemia
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Subcutaneous abscess
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Superinfection bacterial
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
1 / 197 (0.51%) |
0 / 844 (0.00%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Thrombophlebitis septic
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract infection bacterial
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Viral myocarditis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Viral sepsis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
0 / 3597 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
|
|
Hyperkalaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
2 / 844 (0.24%) |
2 / 3597 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 0 |
Metabolic acidosis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
2 / 844 (0.24%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Acidosis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
Diabetes mellitus
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
2 / 3597 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Fluid overload
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypernatraemia
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypocalcaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
2 / 3597 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
1 / 844 (0.12%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
2 / 3597 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Decreased appetite
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic ketoacidosis
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Hypovolaemia
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |
Malnutrition
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
Type 2 diabetes mellitus
|
|
|
|
|
subjects affected / exposed
|
0 / 200 (0.00%) |
0 / 197 (0.00%) |
0 / 844 (0.00%) |
1 / 3597 (0.03%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
0 / 0 |