Serious adverse events
|
Remdesivir 10 Days |
Remdesivir 5 Days |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
865 / 1786 (48.43%) |
58 / 293 (19.80%) |
number of deaths (all causes)
|
761 |
48 |
number of deaths resulting from adverse events
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Pancreatic carcinoma
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Plasma cell myeloma
|
|
|
subjects affected / exposed
|
0 / 1786 (0.00%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Vascular disorders
|
|
|
Hypotension
|
|
|
subjects affected / exposed
|
34 / 1786 (1.90%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 34 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 11 |
0 / 0 |
Shock
|
|
|
subjects affected / exposed
|
17 / 1786 (0.95%) |
3 / 293 (1.02%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 10 |
0 / 1 |
Haemodynamic instability
|
|
|
subjects affected / exposed
|
9 / 1786 (0.50%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Shock haemorrhagic
|
|
|
subjects affected / exposed
|
8 / 1786 (0.45%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
1 / 8 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 6 |
0 / 0 |
Hypertension
|
|
|
subjects affected / exposed
|
3 / 1786 (0.17%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
2 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypovolaemic shock
|
|
|
subjects affected / exposed
|
2 / 1786 (0.11%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Peripheral ischaemia
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bloody discharge
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Circulatory collapse
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cyanosis
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive urgency
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypotensive crisis
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Peripheral artery thrombosis
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombosis
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
Extubation
|
|
|
subjects affected / exposed
|
4 / 1786 (0.22%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
Hospice care
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
General disorders and administration site conditions
|
|
|
Multiple organ dysfunction syndrome
|
|
|
subjects affected / exposed
|
79 / 1786 (4.42%) |
10 / 293 (3.41%) |
occurrences causally related to treatment / all
|
1 / 79 |
0 / 10 |
deaths causally related to treatment / all
|
1 / 72 |
0 / 10 |
Cardiac death
|
|
|
subjects affected / exposed
|
6 / 1786 (0.34%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 0 |
Death
|
|
|
subjects affected / exposed
|
4 / 1786 (0.22%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 0 |
Pyrexia
|
|
|
subjects affected / exposed
|
2 / 1786 (0.11%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain death
|
|
|
subjects affected / exposed
|
2 / 1786 (0.11%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Multi-organ disorder
|
|
|
subjects affected / exposed
|
2 / 1786 (0.11%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Complication associated with device
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Condition aggravated
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug interaction
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperthermia
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
Cytokine storm
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
Respiratory failure
|
|
|
subjects affected / exposed
|
141 / 1786 (7.89%) |
19 / 293 (6.48%) |
occurrences causally related to treatment / all
|
1 / 141 |
0 / 19 |
deaths causally related to treatment / all
|
1 / 112 |
0 / 15 |
Acute respiratory failure
|
|
|
subjects affected / exposed
|
77 / 1786 (4.31%) |
3 / 293 (1.02%) |
occurrences causally related to treatment / all
|
0 / 77 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 71 |
0 / 1 |
Pneumothorax
|
|
|
subjects affected / exposed
|
54 / 1786 (3.02%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 54 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 17 |
0 / 0 |
Acute respiratory distress syndrome
|
|
|
subjects affected / exposed
|
40 / 1786 (2.24%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 40 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 35 |
0 / 1 |
Hypoxia
|
|
|
subjects affected / exposed
|
30 / 1786 (1.68%) |
2 / 293 (0.68%) |
occurrences causally related to treatment / all
|
0 / 30 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 20 |
0 / 0 |
Pulmonary embolism
|
|
|
subjects affected / exposed
|
17 / 1786 (0.95%) |
2 / 293 (0.68%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 13 |
0 / 1 |
Respiratory distress
|
|
|
subjects affected / exposed
|
18 / 1786 (1.01%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 10 |
0 / 0 |
Respiratory disorder
|
|
|
subjects affected / exposed
|
11 / 1786 (0.62%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 7 |
0 / 0 |
Pneumomediastinum
|
|
|
subjects affected / exposed
|
6 / 1786 (0.34%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Respiratory acidosis
|
|
|
subjects affected / exposed
|
5 / 1786 (0.28%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
Pleural effusion
|
|
|
subjects affected / exposed
|
4 / 1786 (0.22%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory arrest
|
|
|
subjects affected / exposed
|
3 / 1786 (0.17%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
Dyspnoea
|
|
|
subjects affected / exposed
|
2 / 1786 (0.11%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Haemothorax
|
|
|
subjects affected / exposed
|
3 / 1786 (0.17%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Lung consolidation
|
|
|
subjects affected / exposed
|
3 / 1786 (0.17%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pneumothorax spontaneous
|
|
|
subjects affected / exposed
|
3 / 1786 (0.17%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pulmonary haemorrhage
|
|
|
subjects affected / exposed
|
3 / 1786 (0.17%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
Chronic obstructive pulmonary disease
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Dependence on respirator
|
|
|
subjects affected / exposed
|
2 / 1786 (0.11%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
subjects affected / exposed
|
2 / 1786 (0.11%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hypercapnia
|
|
|
subjects affected / exposed
|
2 / 1786 (0.11%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Pneumonitis
|
|
|
subjects affected / exposed
|
2 / 1786 (0.11%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Bronchial secretion retention
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cystic lung disease
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspnoea exertional
|
|
|
subjects affected / exposed
|
0 / 1786 (0.00%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Interstitial lung disease
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lung opacity
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mediastinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pneumonia aspiration
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pulmonary fibrosis
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pulmonary oedema
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Respiratory gas exchange disorder
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stridor
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tachypnoea
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Psychiatric disorders
|
|
|
Delirium
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Intensive care unit delirium
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Product issues
|
|
|
Device connection issue
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device dislocation
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device leakage
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombosis in device
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigations
|
|
|
Alanine aminotransferase increased
|
|
|
subjects affected / exposed
|
19 / 1786 (1.06%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
8 / 19 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 6 |
0 / 0 |
Blood creatinine increased
|
|
|
subjects affected / exposed
|
16 / 1786 (0.90%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
2 / 16 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 0 |
Aspartate aminotransferase increased
|
|
|
subjects affected / exposed
|
13 / 1786 (0.73%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
6 / 13 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Liver function test increased
|
|
|
subjects affected / exposed
|
13 / 1786 (0.73%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
4 / 13 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Transaminases increased
|
|
|
subjects affected / exposed
|
8 / 1786 (0.45%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
8 / 8 |
0 / 1 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Creatinine renal clearance abnormal
|
|
|
subjects affected / exposed
|
8 / 1786 (0.45%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Creatinine renal clearance decreased
|
|
|
subjects affected / exposed
|
7 / 1786 (0.39%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Glomerular filtration rate abnormal
|
|
|
subjects affected / exposed
|
6 / 1786 (0.34%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
2 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 1 |
Blood bilirubin increased
|
|
|
subjects affected / exposed
|
4 / 1786 (0.22%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
3 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glomerular filtration rate decreased
|
|
|
subjects affected / exposed
|
3 / 1786 (0.17%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Haemoglobin decreased
|
|
|
subjects affected / exposed
|
4 / 1786 (0.22%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oxygen saturation decreased
|
|
|
subjects affected / exposed
|
3 / 1786 (0.17%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hepatic enzyme increased
|
|
|
subjects affected / exposed
|
3 / 1786 (0.17%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcus test positive
|
|
|
subjects affected / exposed
|
3 / 1786 (0.17%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aspergillus test positive
|
|
|
subjects affected / exposed
|
2 / 1786 (0.11%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood creatine phosphokinase increased
|
|
|
subjects affected / exposed
|
2 / 1786 (0.11%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood creatinine abnormal
|
|
|
subjects affected / exposed
|
2 / 1786 (0.11%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Klebsiella test positive
|
|
|
subjects affected / exposed
|
2 / 1786 (0.11%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alanine aminotransferase abnormal
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aspartate aminotransferase abnormal
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood alkaline phosphatase increased
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood bilirubin abnormal
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood potassium abnormal
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Blood pressure abnormal
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Blood sodium decreased
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood urea increased
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
C-reactive protein increased
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carbon dioxide abnormal
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Chest X-ray abnormal
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Computerised tomogram abdomen abnormal
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Creatinine renal clearance increased
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Electrocardiogram QRS complex prolonged
|
|
|
subjects affected / exposed
|
0 / 1786 (0.00%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrocardiogram T wave inversion
|
|
|
subjects affected / exposed
|
0 / 1786 (0.00%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Fibrin D dimer increased
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fungal test positive
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gamma-glutamyltransferase increased
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gram stain positive
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inflammatory marker increased
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Low density lipoprotein increased
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mean arterial pressure decreased
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oxygen saturation abnormal
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Serum ferritin increased
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Troponin increased
|
|
|
subjects affected / exposed
|
0 / 1786 (0.00%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Urine output decreased
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
Brain herniation
|
|
|
subjects affected / exposed
|
3 / 1786 (0.17%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
Barotrauma
|
|
|
subjects affected / exposed
|
2 / 1786 (0.11%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Endotracheal intubation complication
|
|
|
subjects affected / exposed
|
2 / 1786 (0.11%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal procedural complication
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Infusion related reaction
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mechanical ventilation complication
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Post procedural oedema
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Product dose omission issue
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheal injury
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Tracheostomy malfunction
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cardiac disorders
|
|
|
Cardiac arrest
|
|
|
subjects affected / exposed
|
163 / 1786 (9.13%) |
8 / 293 (2.73%) |
occurrences causally related to treatment / all
|
3 / 165 |
0 / 8 |
deaths causally related to treatment / all
|
3 / 137 |
0 / 7 |
Cardio-respiratory arrest
|
|
|
subjects affected / exposed
|
72 / 1786 (4.03%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
1 / 73 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 67 |
0 / 0 |
Pulseless electrical activity
|
|
|
subjects affected / exposed
|
16 / 1786 (0.90%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 9 |
0 / 0 |
Bradycardia
|
|
|
subjects affected / exposed
|
12 / 1786 (0.67%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
1 / 12 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 8 |
0 / 0 |
Atrial fibrillation
|
|
|
subjects affected / exposed
|
6 / 1786 (0.34%) |
2 / 293 (0.68%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Cardiac failure
|
|
|
subjects affected / exposed
|
6 / 1786 (0.34%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 0 |
Cardiogenic shock
|
|
|
subjects affected / exposed
|
6 / 1786 (0.34%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 0 |
Supraventricular tachycardia
|
|
|
subjects affected / exposed
|
6 / 1786 (0.34%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Arrhythmia
|
|
|
subjects affected / exposed
|
6 / 1786 (0.34%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 0 |
Tachycardia
|
|
|
subjects affected / exposed
|
4 / 1786 (0.22%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
2 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Ventricular tachycardia
|
|
|
subjects affected / exposed
|
5 / 1786 (0.28%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Myocarditis
|
|
|
subjects affected / exposed
|
2 / 1786 (0.11%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Acute myocardial infarction
|
|
|
subjects affected / exposed
|
2 / 1786 (0.11%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure acute
|
|
|
subjects affected / exposed
|
2 / 1786 (0.11%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Myocardial infarction
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Sinus arrest
|
|
|
subjects affected / exposed
|
2 / 1786 (0.11%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus tachycardia
|
|
|
subjects affected / exposed
|
2 / 1786 (0.11%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Ventricular arrhythmia
|
|
|
subjects affected / exposed
|
2 / 1786 (0.11%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Atrial flutter
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorder
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cardiac failure congestive
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiomyopathy
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiopulmonary failure
|
|
|
subjects affected / exposed
|
0 / 1786 (0.00%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cardiovascular insufficiency
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cor pulmonale
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Extrasystoles
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericardial effusion
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericarditis
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Right ventricular failure
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Sinus bradycardia
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular fibrillation
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Nervous system disorders
|
|
|
Cerebrovascular accident
|
|
|
subjects affected / exposed
|
7 / 1786 (0.39%) |
3 / 293 (1.02%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
Encephalopathy
|
|
|
subjects affected / exposed
|
7 / 1786 (0.39%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Haemorrhage intracranial
|
|
|
subjects affected / exposed
|
7 / 1786 (0.39%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 0 |
Cerebral haemorrhage
|
|
|
subjects affected / exposed
|
6 / 1786 (0.34%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
Haemorrhagic stroke
|
|
|
subjects affected / exposed
|
5 / 1786 (0.28%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
Metabolic encephalopathy
|
|
|
subjects affected / exposed
|
4 / 1786 (0.22%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral infarction
|
|
|
subjects affected / exposed
|
3 / 1786 (0.17%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Ischaemic stroke
|
|
|
subjects affected / exposed
|
3 / 1786 (0.17%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Seizure
|
|
|
subjects affected / exposed
|
3 / 1786 (0.17%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Toxic encephalopathy
|
|
|
subjects affected / exposed
|
2 / 1786 (0.11%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intensive care unit acquired weakness
|
|
|
subjects affected / exposed
|
2 / 1786 (0.11%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basal ganglia haematoma
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain injury
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Brain oedema
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cerebellar infarction
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral ischaemia
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coma
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Generalised tonic-clonic seizure
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypotonia
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hypoxic-ischaemic encephalopathy
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lethargy
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental impairment
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Moyamoya disease
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subarachnoid haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tremor
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Unresponsive to stimuli
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
Anaemia
|
|
|
subjects affected / exposed
|
8 / 1786 (0.45%) |
2 / 293 (0.68%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Disseminated intravascular coagulation
|
|
|
subjects affected / exposed
|
5 / 1786 (0.28%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Blood loss anaemia
|
|
|
subjects affected / exposed
|
3 / 1786 (0.17%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukocytosis
|
|
|
subjects affected / exposed
|
3 / 1786 (0.17%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
subjects affected / exposed
|
3 / 1786 (0.17%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coagulopathy
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heparin-induced thrombocytopenia
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
Dysphagia
|
|
|
subjects affected / exposed
|
14 / 1786 (0.78%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
12 / 1786 (0.67%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
1 / 12 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Retroperitoneal haemorrhage
|
|
|
subjects affected / exposed
|
4 / 1786 (0.22%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
2 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
2 / 3 |
0 / 0 |
Mouth haemorrhage
|
|
|
subjects affected / exposed
|
3 / 1786 (0.17%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Haematochezia
|
|
|
subjects affected / exposed
|
2 / 1786 (0.11%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Intra-abdominal haemorrhage
|
|
|
subjects affected / exposed
|
2 / 1786 (0.11%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 2 |
0 / 0 |
Lower gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
2 / 1786 (0.11%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedematous pancreatitis
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal haemorrhage
|
|
|
subjects affected / exposed
|
2 / 1786 (0.11%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Colitis
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Colitis ischaemic
|
|
|
subjects affected / exposed
|
0 / 1786 (0.00%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Diverticular perforation
|
|
|
subjects affected / exposed
|
0 / 1786 (0.00%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer perforation
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorder
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Gastrointestinal necrosis
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Intestinal ischaemia
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal perforation
|
|
|
subjects affected / exposed
|
0 / 1786 (0.00%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Large intestine perforation
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obstruction gastric
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pancreatitis
|
|
|
subjects affected / exposed
|
0 / 1786 (0.00%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retroperitoneal haematoma
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
Cholecystitis
|
|
|
subjects affected / exposed
|
3 / 1786 (0.17%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hepatic failure
|
|
|
subjects affected / exposed
|
3 / 1786 (0.17%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Liver injury
|
|
|
subjects affected / exposed
|
2 / 1786 (0.11%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Acute hepatic failure
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
Drug-induced liver injury
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis toxic
|
|
|
subjects affected / exposed
|
0 / 1786 (0.00%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperbilirubinaemia
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver disorder
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-alcoholic steatohepatitis
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
Subcutaneous emphysema
|
|
|
subjects affected / exposed
|
3 / 1786 (0.17%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angioedema
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Decubitus ulcer
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rash macular
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rash maculo-papular
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
Acute kidney injury
|
|
|
subjects affected / exposed
|
137 / 1786 (7.67%) |
3 / 293 (1.02%) |
occurrences causally related to treatment / all
|
11 / 138 |
0 / 3 |
deaths causally related to treatment / all
|
2 / 25 |
0 / 1 |
Renal failure
|
|
|
subjects affected / exposed
|
28 / 1786 (1.57%) |
5 / 293 (1.71%) |
occurrences causally related to treatment / all
|
2 / 28 |
1 / 5 |
deaths causally related to treatment / all
|
1 / 11 |
0 / 1 |
Renal impairment
|
|
|
subjects affected / exposed
|
8 / 1786 (0.45%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
1 / 8 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematuria
|
|
|
subjects affected / exposed
|
5 / 1786 (0.28%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal tubular necrosis
|
|
|
subjects affected / exposed
|
3 / 1786 (0.17%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Azotaemia
|
|
|
subjects affected / exposed
|
2 / 1786 (0.11%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal injury
|
|
|
subjects affected / exposed
|
2 / 1786 (0.11%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anuria
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Oliguria
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Proteinuria
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract obstruction
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
Rhabdomyolysis
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
Septic shock
|
|
|
subjects affected / exposed
|
79 / 1786 (4.42%) |
4 / 293 (1.37%) |
occurrences causally related to treatment / all
|
1 / 81 |
0 / 4 |
deaths causally related to treatment / all
|
1 / 53 |
0 / 3 |
Pneumonia
|
|
|
subjects affected / exposed
|
30 / 1786 (1.68%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 30 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 22 |
0 / 1 |
Covid-19
|
|
|
subjects affected / exposed
|
29 / 1786 (1.62%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 29 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 29 |
0 / 0 |
Sepsis
|
|
|
subjects affected / exposed
|
21 / 1786 (1.18%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 21 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 10 |
0 / 1 |
Covid-19 pneumonia
|
|
|
subjects affected / exposed
|
18 / 1786 (1.01%) |
3 / 293 (1.02%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 16 |
0 / 3 |
Systemic candida
|
|
|
subjects affected / exposed
|
5 / 1786 (0.28%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
Staphylococcal bacteraemia
|
|
|
subjects affected / exposed
|
4 / 1786 (0.22%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Pneumonia bacterial
|
|
|
subjects affected / exposed
|
4 / 1786 (0.22%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Pneumonia staphylococcal
|
|
|
subjects affected / exposed
|
3 / 1786 (0.17%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Bacteraemia
|
|
|
subjects affected / exposed
|
3 / 1786 (0.17%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Bacterial infection
|
|
|
subjects affected / exposed
|
3 / 1786 (0.17%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia acinetobacter
|
|
|
subjects affected / exposed
|
3 / 1786 (0.17%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Staphylococcal sepsis
|
|
|
subjects affected / exposed
|
3 / 1786 (0.17%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acinetobacter infection
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Bacterial sepsis
|
|
|
subjects affected / exposed
|
2 / 1786 (0.11%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Klebsiella bacteraemia
|
|
|
subjects affected / exposed
|
2 / 1786 (0.11%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pneumonia viral
|
|
|
subjects affected / exposed
|
2 / 1786 (0.11%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Acinetobacter sepsis
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Bacterial abdominal infection
|
|
|
subjects affected / exposed
|
0 / 1786 (0.00%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Bacterial tracheitis
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Candida infection
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Empyema
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterococcal sepsis
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia bacteraemia
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Escherichia infection
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia sepsis
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Klebsiella sepsis
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nosocomial infection
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pneumocystis jirovecii pneumonia
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pneumonia escherichia
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pseudomembranous colitis
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pseudomonal bacteraemia
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Severe acute respiratory syndrome
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Staphylococcal infection
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Streptococcal bacteraemia
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheobronchitis
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral infection
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
Metabolic acidosis
|
|
|
subjects affected / exposed
|
6 / 1786 (0.34%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 2 |
0 / 0 |
Hyperkalaemia
|
|
|
subjects affected / exposed
|
5 / 1786 (0.28%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Acidosis
|
|
|
subjects affected / exposed
|
4 / 1786 (0.22%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Hypernatraemia
|
|
|
subjects affected / exposed
|
3 / 1786 (0.17%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fluid overload
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
subjects affected / exposed
|
2 / 1786 (0.11%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic alkalosis
|
|
|
subjects affected / exposed
|
2 / 1786 (0.11%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Decreased appetite
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrolyte imbalance
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypocalcaemia
|
|
|
subjects affected / exposed
|
0 / 1786 (0.00%) |
1 / 293 (0.34%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypomagnesaemia
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lactic acidosis
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malnutrition
|
|
|
subjects affected / exposed
|
1 / 1786 (0.06%) |
0 / 293 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |