Non-serious adverse events
|
ELAD Treatment |
Control |
Total subjects affected by non serious adverse events
|
|
|
subjects affected / exposed
|
95 / 95 (100.00%) |
107 / 108 (99.07%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Colon adenoma
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Colonic polyp
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Vascular disorders
|
|
|
Abdominal compartment syndrome
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
0 / 108 (0.00%) |
occurrences all number
|
2 |
0 |
Aneurysm
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Angiopathy
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Aortic aneurysm
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Aortic arteriosclerosis
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Arteriosclerosis
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Arteriospasm coronary
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Cardiovascular deconditioning
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Contusion
|
|
|
subjects affected / exposed
|
8 / 95 (8.42%) |
6 / 108 (5.56%) |
occurrences all number
|
8 |
6 |
Coronary artery disease
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Cyanosis
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Deep vein thrombosis
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
2 |
1 |
Dizziness postural
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
1 / 108 (0.93%) |
occurrences all number
|
2 |
1 |
Gastric haemorrhage
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Gastric varices
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
4 / 95 (4.21%) |
4 / 108 (3.70%) |
occurrences all number
|
4 |
4 |
Gingival bleeding
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Haematochezia
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
4 / 108 (3.70%) |
occurrences all number
|
3 |
4 |
Haematoma
|
|
|
subjects affected / exposed
|
6 / 95 (6.32%) |
3 / 108 (2.78%) |
occurrences all number
|
6 |
3 |
Haemodynamic instability
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Haemoptysis
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
2 / 108 (1.85%) |
occurrences all number
|
3 |
2 |
Haemorrhage
|
|
|
subjects affected / exposed
|
4 / 95 (4.21%) |
0 / 108 (0.00%) |
occurrences all number
|
5 |
0 |
Haemorrhage intracranial
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Haemorrhage urinary tract
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Haemorrhoids
|
|
|
subjects affected / exposed
|
5 / 95 (5.26%) |
8 / 108 (7.41%) |
occurrences all number
|
5 |
8 |
Haemothorax
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Hypertension
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
2 / 108 (1.85%) |
occurrences all number
|
1 |
2 |
Hypotension
|
|
|
subjects affected / exposed
|
29 / 95 (30.53%) |
18 / 108 (16.67%) |
occurrences all number
|
37 |
20 |
Hypovolaemic shock
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
0 / 108 (0.00%) |
occurrences all number
|
2 |
0 |
Melaena
|
|
|
subjects affected / exposed
|
5 / 95 (5.26%) |
3 / 108 (2.78%) |
occurrences all number
|
6 |
4 |
Mucosal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Orthostatic hypotension
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Pallor
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Penile haemorrhage
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Peripheral artery aneurysm
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Petechiae
|
|
|
subjects affected / exposed
|
4 / 95 (4.21%) |
2 / 108 (1.85%) |
occurrences all number
|
5 |
2 |
Pharyngeal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Portal hypertensive gastropathy
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
9 / 108 (8.33%) |
occurrences all number
|
3 |
9 |
Portal vein thrombosis
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Presyncope
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Procedural haemorrhage
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Pulmonary alveolar haemorrhage
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Pulmonary congestion
|
|
|
subjects affected / exposed
|
5 / 95 (5.26%) |
0 / 108 (0.00%) |
occurrences all number
|
5 |
0 |
Pulmonary hypertension
|
|
|
subjects affected / exposed
|
4 / 95 (4.21%) |
0 / 108 (0.00%) |
occurrences all number
|
4 |
0 |
Purpura
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
3 / 108 (2.78%) |
occurrences all number
|
0 |
3 |
Retroperitoneal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Scrotal haematoma
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Septic shock
|
|
|
subjects affected / exposed
|
5 / 95 (5.26%) |
1 / 108 (0.93%) |
occurrences all number
|
5 |
1 |
Shock
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Shock haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Spider naevus
|
|
|
subjects affected / exposed
|
5 / 95 (5.26%) |
5 / 108 (4.63%) |
occurrences all number
|
5 |
5 |
Splenic infarction
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Splenic varices
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Splenic vein thrombosis
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
2 |
Syncope
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Systemic inflammatory response syndrome
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
3 / 108 (2.78%) |
occurrences all number
|
2 |
3 |
Telangiectasia
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
2 / 108 (1.85%) |
occurrences all number
|
0 |
2 |
Upper gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Urogenital haemorrhage
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Vaginal haemorrhage
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
1 / 108 (0.93%) |
occurrences all number
|
3 |
1 |
Varices oesophageal
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
6 / 108 (5.56%) |
occurrences all number
|
3 |
6 |
Vascular anomaly
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
0 / 108 (0.00%) |
occurrences all number
|
2 |
0 |
Vasodilitation
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Surgical and medical procedures
|
|
|
Biliary drainage
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Bladder catheterisation
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Central venous catheterisation
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Extubation
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Intravenous catheter management
|
|
|
subjects affected / exposed
|
4 / 95 (4.21%) |
0 / 108 (0.00%) |
occurrences all number
|
4 |
0 |
Removal of foreign body from external ear
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Suture insertion
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Wound drainage
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
General disorders and administration site conditions
|
|
|
Administration site pain
|
|
|
subjects affected / exposed
|
4 / 95 (4.21%) |
0 / 108 (0.00%) |
occurrences all number
|
4 |
0 |
Asthenia
|
|
|
subjects affected / exposed
|
6 / 95 (6.32%) |
12 / 108 (11.11%) |
occurrences all number
|
7 |
14 |
Catheter site haemorrhage
|
|
|
subjects affected / exposed
|
9 / 95 (9.47%) |
4 / 108 (3.70%) |
occurrences all number
|
10 |
4 |
Chest pain
|
|
|
subjects affected / exposed
|
8 / 95 (8.42%) |
5 / 108 (4.63%) |
occurrences all number
|
9 |
5 |
Cyst
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
2 / 108 (1.85%) |
occurrences all number
|
0 |
2 |
Device component issue
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Device damage
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Device occlusion
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Effusion
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
2 |
Fatigue
|
|
|
subjects affected / exposed
|
7 / 95 (7.37%) |
6 / 108 (5.56%) |
occurrences all number
|
7 |
7 |
Feeling abnormal
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Gait disturbance
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
3 / 108 (2.78%) |
occurrences all number
|
1 |
3 |
Hyperthermia
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Hypothermia
|
|
|
subjects affected / exposed
|
4 / 95 (4.21%) |
1 / 108 (0.93%) |
occurrences all number
|
4 |
1 |
Inflammation
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Infusion site haemorrhage
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
0 / 108 (0.00%) |
occurrences all number
|
2 |
0 |
Local swelling
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Malaise
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
2 / 108 (1.85%) |
occurrences all number
|
0 |
2 |
Medical device complication
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
1 / 108 (0.93%) |
occurrences all number
|
3 |
1 |
Mucosal dryness
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
2 / 108 (1.85%) |
occurrences all number
|
1 |
2 |
Multi-organ failure
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
0 / 108 (0.00%) |
occurrences all number
|
2 |
0 |
Pain
|
|
|
subjects affected / exposed
|
7 / 95 (7.37%) |
9 / 108 (8.33%) |
occurrences all number
|
8 |
10 |
Puncture site haemorrhage
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Puncture site pain
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Pyrexia
|
|
|
subjects affected / exposed
|
25 / 95 (26.32%) |
10 / 108 (9.26%) |
occurrences all number
|
28 |
10 |
Secretion discharge
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Temperature intolerance
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Ulcer
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Oedema peripheral
|
|
|
subjects affected / exposed
|
32 / 95 (33.68%) |
33 / 108 (30.56%) |
occurrences all number
|
38 |
41 |
Immune system disorders
|
|
|
Hypersensitivity
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Reproductive system and breast disorders
|
|
|
Breast mass
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Cervical dysplasia
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Genital swelling
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Gynaecomastia
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Menorrhagia
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Prostatic calcification
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Scrotal irritation
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Scrotal oedema
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
4 / 108 (3.70%) |
occurrences all number
|
2 |
4 |
Scrotal pain
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Vaginal infection
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Vaginal lesion
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
Acquired diaphragmatic eventration
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Acute respiratory distress syndrome
|
|
|
subjects affected / exposed
|
4 / 95 (4.21%) |
2 / 108 (1.85%) |
occurrences all number
|
5 |
2 |
Acute respiratory failure
|
|
|
subjects affected / exposed
|
6 / 95 (6.32%) |
2 / 108 (1.85%) |
occurrences all number
|
6 |
2 |
Asthma
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Atelectasis
|
|
|
subjects affected / exposed
|
14 / 95 (14.74%) |
6 / 108 (5.56%) |
occurrences all number
|
15 |
6 |
Bronchial disorder
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Bronchospasm
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Chronic obstructive pulmonary disease
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Cough
|
|
|
subjects affected / exposed
|
6 / 95 (6.32%) |
8 / 108 (7.41%) |
occurrences all number
|
6 |
8 |
Dry throat
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Dyspnoea
|
|
|
subjects affected / exposed
|
21 / 95 (22.11%) |
21 / 108 (19.44%) |
occurrences all number
|
25 |
26 |
Epistaxis
|
|
|
subjects affected / exposed
|
10 / 95 (10.53%) |
6 / 108 (5.56%) |
occurrences all number
|
11 |
6 |
Hepatic hydrothorax
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Hiccups
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
3 / 108 (2.78%) |
occurrences all number
|
1 |
3 |
Hyperventilation
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Hypopnoea
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
1 / 108 (0.93%) |
occurrences all number
|
3 |
1 |
Hypoventilation
|
|
|
subjects affected / exposed
|
4 / 95 (4.21%) |
0 / 108 (0.00%) |
occurrences all number
|
4 |
0 |
Hypoxia
|
|
|
subjects affected / exposed
|
6 / 95 (6.32%) |
4 / 108 (3.70%) |
occurrences all number
|
6 |
4 |
Increased bronchial secretion
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
1 / 108 (0.93%) |
occurrences all number
|
2 |
1 |
Influenza
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Laryngitis bacterial
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Lower respiratory tract infection
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
0 / 108 (0.00%) |
occurrences all number
|
2 |
0 |
Lung consolidation
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Lung disorder
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Lung infiltration
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
2 / 108 (1.85%) |
occurrences all number
|
0 |
2 |
Lung neoplasm
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Musculoskeletal chest pain
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Nasal congestion
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Nasal dryness
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Non-cardiac chest pain
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Obstructive airways disorder
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Oropharyngeal pain
|
|
|
subjects affected / exposed
|
5 / 95 (5.26%) |
4 / 108 (3.70%) |
occurrences all number
|
5 |
4 |
Pharyngeal erythema
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Pleural effusion
|
|
|
subjects affected / exposed
|
12 / 95 (12.63%) |
14 / 108 (12.96%) |
occurrences all number
|
12 |
14 |
Pleuritic pain
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Pneumonia aspiration
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
2 / 108 (1.85%) |
occurrences all number
|
0 |
2 |
Pneumothorax
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
1 / 108 (0.93%) |
occurrences all number
|
4 |
1 |
Productive cough
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
2 / 108 (1.85%) |
occurrences all number
|
2 |
2 |
Pulmonary mass
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Pulmonary oedema
|
|
|
subjects affected / exposed
|
7 / 95 (7.37%) |
5 / 108 (4.63%) |
occurrences all number
|
8 |
5 |
Rales
|
|
|
subjects affected / exposed
|
8 / 95 (8.42%) |
6 / 108 (5.56%) |
occurrences all number
|
8 |
6 |
Respiration abnormal
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Respiratory acidosis
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Respiratory alkalosis
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
1 / 108 (0.93%) |
occurrences all number
|
2 |
1 |
Respiratory distress
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
0 / 108 (0.00%) |
occurrences all number
|
3 |
0 |
respiratory failure
|
|
|
subjects affected / exposed
|
6 / 95 (6.32%) |
4 / 108 (3.70%) |
occurrences all number
|
6 |
4 |
Respiratory tract congestion
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Rhinitis allergic
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Rhonchi
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Sleep apnoea syndrome
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
2 / 108 (1.85%) |
occurrences all number
|
0 |
2 |
Tachypnoea
|
|
|
subjects affected / exposed
|
7 / 95 (7.37%) |
6 / 108 (5.56%) |
occurrences all number
|
7 |
7 |
Vocal cord disorder
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Wheezing
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
4 / 108 (3.70%) |
occurrences all number
|
3 |
4 |
Psychiatric disorders
|
|
|
Adjustment disorder
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Aggression
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Agitation
|
|
|
subjects affected / exposed
|
16 / 95 (16.84%) |
8 / 108 (7.41%) |
occurrences all number
|
17 |
8 |
Alcohol abuse
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Amnesia
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
2 |
0 |
Anxiety
|
|
|
subjects affected / exposed
|
21 / 95 (22.11%) |
9 / 108 (8.33%) |
occurrences all number
|
22 |
10 |
Apraxia
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Catatonia
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Circadian rhythm sleep disorder
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Confusional state
|
|
|
subjects affected / exposed
|
14 / 95 (14.74%) |
3 / 108 (2.78%) |
occurrences all number
|
14 |
3 |
Delirium
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Delirium tremens
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
0 / 108 (0.00%) |
occurrences all number
|
2 |
0 |
Delusion
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Depression
|
|
|
subjects affected / exposed
|
7 / 95 (7.37%) |
7 / 108 (6.48%) |
occurrences all number
|
7 |
7 |
Emotional distress
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Failure to thrive
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
0 / 108 (0.00%) |
occurrences all number
|
2 |
0 |
Hallucination
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
2 / 108 (1.85%) |
occurrences all number
|
3 |
2 |
Hallucination, auditory
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
0 / 108 (0.00%) |
occurrences all number
|
2 |
0 |
Hallucination, visual
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Hypophagia
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Irritability
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Irritable bowel syndrome
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Korsakoff's syndrome
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Memory impairment
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Mental status changes
|
|
|
subjects affected / exposed
|
4 / 95 (4.21%) |
2 / 108 (1.85%) |
occurrences all number
|
4 |
2 |
Panic attack
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Poor quality sleep
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Restlessness
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Selective mutism
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Speech disorder
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Stupor
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
0 / 108 (0.00%) |
occurrences all number
|
2 |
0 |
Suicidal ideation
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Drug abuse
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
2 |
Investigations
|
|
|
Acinetobacter test positive
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Activated partial thromboplastin time prolonged
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
0 / 108 (0.00%) |
occurrences all number
|
3 |
0 |
Alanine aminotransferase increased
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
1 / 108 (0.93%) |
occurrences all number
|
2 |
1 |
Alpha 1 foetoprotein increased
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
2 / 108 (1.85%) |
occurrences all number
|
2 |
3 |
Ammonia abnormal
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Ammonia increased
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
1 / 108 (0.93%) |
occurrences all number
|
3 |
1 |
Antibiotic resistant staphylococcus test positive
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Aspartate aminotransferase increased
|
|
|
subjects affected / exposed
|
7 / 95 (7.37%) |
0 / 108 (0.00%) |
occurrences all number
|
7 |
0 |
Aspiration bronchial
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Bacterial test positive
|
|
|
subjects affected / exposed
|
5 / 95 (5.26%) |
1 / 108 (0.93%) |
occurrences all number
|
5 |
1 |
Blood aldosterone decreased
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Blood amylase increased
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Blood bilirubin increased
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Blood cortisol decreased
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Blood creatinine increased
|
|
|
subjects affected / exposed
|
5 / 95 (5.26%) |
4 / 108 (3.70%) |
occurrences all number
|
5 |
4 |
Blood fibrinogen decreased
|
|
|
subjects affected / exposed
|
4 / 95 (4.21%) |
0 / 108 (0.00%) |
occurrences all number
|
4 |
0 |
Blood glucose fluctuation
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Blood lactate dehydrogenase increased
|
|
|
subjects affected / exposed
|
6 / 95 (6.32%) |
1 / 108 (0.93%) |
occurrences all number
|
6 |
1 |
Blood lactic acid abnormal
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Blood lactic acid increased
|
|
|
subjects affected / exposed
|
4 / 95 (4.21%) |
1 / 108 (0.93%) |
occurrences all number
|
4 |
1 |
Blood magnesium decreased
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Blood phosphorus abnormal
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Blood phosphorus decreased
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Blood potassium abnormal
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Blood pressure decreased
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Blood pressure systolic decreased
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Blood thyroid stimulating hormone increased
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Blood urea increased
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Body surface area increased
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Body temperature decreased
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Body temperature increased
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Breath sounds abnormal
|
|
|
subjects affected / exposed
|
6 / 95 (6.32%) |
4 / 108 (3.70%) |
occurrences all number
|
6 |
4 |
Cardiac murmur
|
|
|
subjects affected / exposed
|
10 / 95 (10.53%) |
8 / 108 (7.41%) |
occurrences all number
|
10 |
10 |
Clostridium test positive
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
1 / 108 (0.93%) |
occurrences all number
|
2 |
1 |
Computerised tomogram head
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Culture urine positive
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
2 / 108 (1.85%) |
occurrences all number
|
1 |
2 |
Drug screen positive
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Electrocardiogram QRS complex abnormal
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Electrocardiogram QT prolonged
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
2 / 108 (1.85%) |
occurrences all number
|
1 |
2 |
Enterococcus test positive
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Full blood count abnormal
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Fungal test positive
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Gamma-glutamyltransferase increased
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Haematocrit decreased
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Haemoglobin decreased
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
2 / 108 (1.85%) |
occurrences all number
|
5 |
2 |
Intraocular pressure increased
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Laboratory test abnormal
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Liver function test abnormal
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Low density lipoprotein increased
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Oxygen saturation decreased
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
2 / 108 (1.85%) |
occurrences all number
|
2 |
2 |
Procalcitonin increased
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
0 / 108 (0.00%) |
occurrences all number
|
2 |
0 |
Pulmonary function test decreased
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
2 / 108 (1.85%) |
occurrences all number
|
2 |
2 |
Respiratory rate increased
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Serum ferritin increased
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Sputum culture positive
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
0 / 108 (0.00%) |
occurrences all number
|
3 |
0 |
Total lung capacity decreased
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
0 / 108 (0.00%) |
occurrences all number
|
2 |
0 |
Urine colour abnormal
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Urine output decreased
|
|
|
subjects affected / exposed
|
4 / 95 (4.21%) |
0 / 108 (0.00%) |
occurrences all number
|
4 |
0 |
Volume blood decreased
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Weight decreased
|
|
|
subjects affected / exposed
|
5 / 95 (5.26%) |
1 / 108 (0.93%) |
occurrences all number
|
5 |
1 |
Injury, poisoning and procedural complications
|
|
|
Catheter site discharge
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Catheter site haematoma
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Catheter site related reaction
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Colon injury
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Excoriation
|
|
|
subjects affected / exposed
|
10 / 95 (10.53%) |
5 / 108 (4.63%) |
occurrences all number
|
10 |
6 |
Fall
|
|
|
subjects affected / exposed
|
8 / 95 (8.42%) |
5 / 108 (4.63%) |
occurrences all number
|
8 |
7 |
Febrile nonhaemolytic transfusion reaction
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Feeding tube complication
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Incision site complication
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Incision site pain
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Injection site haematoma
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Injection site haemorrhage
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
1 / 108 (0.93%) |
occurrences all number
|
2 |
1 |
Rib fracture
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
2 / 108 (1.85%) |
occurrences all number
|
0 |
2 |
Spinal column injury
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Transfusion reaction
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
0 / 108 (0.00%) |
occurrences all number
|
3 |
0 |
Vessel puncture site haematoma
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
0 / 108 (0.00%) |
occurrences all number
|
2 |
0 |
Wound
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
2 / 108 (1.85%) |
occurrences all number
|
2 |
2 |
Wound complication
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Wound secretion
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
1 / 108 (0.93%) |
occurrences all number
|
3 |
1 |
Alcohol poisoning
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Procedural pain
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Congenital, familial and genetic disorders
|
|
|
Arteriovenous malformation
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
2 / 108 (1.85%) |
occurrences all number
|
1 |
2 |
Cardiac disorders
|
|
|
Arrhythmia
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Atrial fibrillation
|
|
|
subjects affected / exposed
|
5 / 95 (5.26%) |
2 / 108 (1.85%) |
occurrences all number
|
6 |
2 |
Atrial flutter
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Bradycardia
|
|
|
subjects affected / exposed
|
4 / 95 (4.21%) |
4 / 108 (3.70%) |
occurrences all number
|
4 |
7 |
Cardiac arrest
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
2 |
0 |
Cardiac failure
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
3 / 108 (2.78%) |
occurrences all number
|
1 |
3 |
Cardiac failure congestive
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Cardiomegaly
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
1 / 108 (0.93%) |
occurrences all number
|
2 |
1 |
Chest discomfort
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Hyperdynamic left ventricle
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Left ventricular dysfunction
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Left ventricular hypertrophy
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Mitral valve incompetence
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
0 / 108 (0.00%) |
occurrences all number
|
3 |
0 |
Palpitations
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Pulmonary valve incompetence
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Right atrial dilatation
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Sinus tachycardia
|
|
|
subjects affected / exposed
|
7 / 95 (7.37%) |
1 / 108 (0.93%) |
occurrences all number
|
7 |
1 |
Supraventricular tachycardia
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Tachycardia
|
|
|
subjects affected / exposed
|
17 / 95 (17.89%) |
10 / 108 (9.26%) |
occurrences all number
|
19 |
10 |
Tricuspid valve incompetence
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
0 / 108 (0.00%) |
occurrences all number
|
2 |
0 |
Ventricular tachycardia
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
2 / 108 (1.85%) |
occurrences all number
|
1 |
2 |
Nervous system disorders
|
|
|
Asterixis
|
|
|
subjects affected / exposed
|
9 / 95 (9.47%) |
16 / 108 (14.81%) |
occurrences all number
|
9 |
16 |
Ataxia
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Balance disorder
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Cerebral atrophy
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Coma
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
2 |
1 |
Coma hepatic
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
1 / 108 (0.93%) |
occurrences all number
|
5 |
1 |
Complex regional pain syndrome
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Convulsion
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
2 / 108 (1.85%) |
occurrences all number
|
2 |
3 |
Coordination abnormal
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Depressed level of consciousness
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Facial spasm
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Headache
|
|
|
subjects affected / exposed
|
11 / 95 (11.58%) |
7 / 108 (6.48%) |
occurrences all number
|
14 |
7 |
Hepatic encephalopathy
|
|
|
subjects affected / exposed
|
36 / 95 (37.89%) |
29 / 108 (26.85%) |
occurrences all number
|
45 |
30 |
Hereditary cerebral degeneration
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
0 / 108 (0.00%) |
occurrences all number
|
2 |
0 |
Hyperreflexia
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
2 / 108 (1.85%) |
occurrences all number
|
3 |
2 |
Hypoaesthesia
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
1 / 108 (0.93%) |
occurrences all number
|
4 |
1 |
Hyporeflexia
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Hyporesponsive to stimuli
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Insomnia
|
|
|
subjects affected / exposed
|
14 / 95 (14.74%) |
15 / 108 (13.89%) |
occurrences all number
|
14 |
15 |
Lethargy
|
|
|
subjects affected / exposed
|
4 / 95 (4.21%) |
5 / 108 (4.63%) |
occurrences all number
|
4 |
5 |
Metabolic encephalopathy
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Mobility decreased
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
0 / 108 (0.00%) |
occurrences all number
|
2 |
0 |
Myoclonic epilepsy
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Myoclonus
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Neuralgia
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Neuropathy peripheral
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
2 |
Nystagmus
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Paraesthesia
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
3 / 108 (2.78%) |
occurrences all number
|
2 |
3 |
Pupils unequal
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Restless legs syndrome
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Somnolence
|
|
|
subjects affected / exposed
|
4 / 95 (4.21%) |
5 / 108 (4.63%) |
occurrences all number
|
4 |
5 |
Tension headache
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Tremor
|
|
|
subjects affected / exposed
|
14 / 95 (14.74%) |
10 / 108 (9.26%) |
occurrences all number
|
14 |
11 |
Dizziness
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
12 / 108 (11.11%) |
occurrences all number
|
3 |
15 |
Blood and lymphatic system disorders
|
|
|
Anaemia
|
|
|
subjects affected / exposed
|
42 / 95 (44.21%) |
17 / 108 (15.74%) |
occurrences all number
|
47 |
19 |
Anaemia macrocytic
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Anisocytosis
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Coagulopathy
|
|
|
subjects affected / exposed
|
29 / 95 (30.53%) |
13 / 108 (12.04%) |
occurrences all number
|
34 |
15 |
Disseminated intravascular coagulation
|
|
|
subjects affected / exposed
|
7 / 95 (7.37%) |
0 / 108 (0.00%) |
occurrences all number
|
7 |
0 |
Haemolysis
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
0 / 108 (0.00%) |
occurrences all number
|
3 |
0 |
Haemolytic anaemia
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Heparin-induced thrombocytopenia
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
0 / 108 (0.00%) |
occurrences all number
|
2 |
0 |
Hypochromasia
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Hypofibrinogenaemia
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
0 / 108 (0.00%) |
occurrences all number
|
2 |
0 |
Hypoprothrombinaemia
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Leukaemoid reaction
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Leukocytosis
|
|
|
subjects affected / exposed
|
13 / 95 (13.68%) |
13 / 108 (12.04%) |
occurrences all number
|
16 |
13 |
Lymphadenopathy
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
1 / 108 (0.93%) |
occurrences all number
|
3 |
1 |
Pancytopenia
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Splenomegaly
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
1 / 108 (0.93%) |
occurrences all number
|
3 |
1 |
Thrombocytopenia
|
|
|
subjects affected / exposed
|
33 / 95 (34.74%) |
12 / 108 (11.11%) |
occurrences all number
|
36 |
12 |
White blood cell disorder
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Ear and labyrinth disorders
|
|
|
Cerumen impaction
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Eye disorders
|
|
|
Dry eye
|
|
|
subjects affected / exposed
|
4 / 95 (4.21%) |
1 / 108 (0.93%) |
occurrences all number
|
4 |
1 |
Eye discharge
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Eye swelling
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Keratitis
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Keratopathy
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Limbal swelling
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Scleral discolouration
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
2 / 108 (1.85%) |
occurrences all number
|
0 |
2 |
Scleral disorder
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Scleral oedema
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
0 / 108 (0.00%) |
occurrences all number
|
3 |
0 |
Ulcerative keratitis
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Vision blurred
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
2 / 108 (1.85%) |
occurrences all number
|
1 |
2 |
Gastrointestinal disorders
|
|
|
Abdominal discomfort
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
1 / 108 (0.93%) |
occurrences all number
|
3 |
1 |
Abdominal distension
|
|
|
subjects affected / exposed
|
16 / 95 (16.84%) |
8 / 108 (7.41%) |
occurrences all number
|
17 |
10 |
Abdominal pain
|
|
|
subjects affected / exposed
|
27 / 95 (28.42%) |
22 / 108 (20.37%) |
occurrences all number
|
37 |
29 |
Abdominal tenderness
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
3 / 108 (2.78%) |
occurrences all number
|
3 |
3 |
Anastomotic ulcer
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Anorectal discomfort
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Bacterascites
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Breath odour
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Colitis
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
2 / 108 (1.85%) |
occurrences all number
|
2 |
2 |
Constipation
|
|
|
subjects affected / exposed
|
19 / 95 (20.00%) |
10 / 108 (9.26%) |
occurrences all number
|
20 |
10 |
Diarrhoea
|
|
|
subjects affected / exposed
|
19 / 95 (20.00%) |
17 / 108 (15.74%) |
occurrences all number
|
20 |
19 |
Diverticulum gastric
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Diverticulum intestinal
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
0 / 108 (0.00%) |
occurrences all number
|
2 |
0 |
Dry mouth
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
0 / 108 (0.00%) |
occurrences all number
|
2 |
0 |
Duodenal ulcer
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
2 / 108 (1.85%) |
occurrences all number
|
0 |
2 |
Duodenogastric reflux
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Dyspepsia
|
|
|
subjects affected / exposed
|
6 / 95 (6.32%) |
4 / 108 (3.70%) |
occurrences all number
|
6 |
4 |
Dysphagia
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
2 / 108 (1.85%) |
occurrences all number
|
2 |
2 |
Faecal incontinence
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
3 / 108 (2.78%) |
occurrences all number
|
3 |
3 |
Faeces discoloured
|
|
|
subjects affected / exposed
|
4 / 95 (4.21%) |
4 / 108 (3.70%) |
occurrences all number
|
4 |
4 |
Faeces pale
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Flatulence
|
|
|
subjects affected / exposed
|
5 / 95 (5.26%) |
2 / 108 (1.85%) |
occurrences all number
|
5 |
2 |
Frequent bowel movements
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Functional gastrointestinal disorder
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Gastric mucosal lesion
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Gastritis
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
3 / 108 (2.78%) |
occurrences all number
|
0 |
3 |
Gastritis erosive
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Gastrointestinal oedema
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Gastrointestinal sounds abnormal
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
2 / 108 (1.85%) |
occurrences all number
|
3 |
2 |
Glossitis
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Haematemesis
|
|
|
subjects affected / exposed
|
6 / 95 (6.32%) |
4 / 108 (3.70%) |
occurrences all number
|
6 |
5 |
Hiatus hernia
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
2 / 108 (1.85%) |
occurrences all number
|
2 |
2 |
Ileus
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
2 / 108 (1.85%) |
occurrences all number
|
2 |
2 |
Impaired gastric emptying
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Inguinal hernia
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
2 / 108 (1.85%) |
occurrences all number
|
1 |
2 |
Mouth haemorrhage
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
2 / 108 (1.85%) |
occurrences all number
|
1 |
2 |
Mouth ulceration
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Nausea
|
|
|
subjects affected / exposed
|
15 / 95 (15.79%) |
23 / 108 (21.30%) |
occurrences all number
|
18 |
27 |
Odynophagia
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Oesophageal ulcer
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
2 / 108 (1.85%) |
occurrences all number
|
1 |
2 |
Oesophagitis
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
3 / 108 (2.78%) |
occurrences all number
|
0 |
3 |
Oral discharge
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Oral disorder
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Oral pain
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Pancreatitis
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
2 / 108 (1.85%) |
occurrences all number
|
0 |
2 |
Peptic ulcer
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Peritoneal disorder
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Pneumatosis intestinalis
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Pneumoperitoneum
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Proctalgia
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
4 / 108 (3.70%) |
occurrences all number
|
0 |
4 |
Rectal haemorrhage
|
|
|
subjects affected / exposed
|
8 / 95 (8.42%) |
4 / 108 (3.70%) |
occurrences all number
|
9 |
4 |
Rectal ulcer
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Retroperitoneal haematoma
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
0 / 108 (0.00%) |
occurrences all number
|
2 |
0 |
Small intestinal obstruction
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Tongue coated
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Tongue disorder
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Tooth disorder
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Toothache
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Umbilical hernia
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
3 / 108 (2.78%) |
occurrences all number
|
3 |
3 |
Vomiting
|
|
|
subjects affected / exposed
|
14 / 95 (14.74%) |
17 / 108 (15.74%) |
occurrences all number
|
17 |
21 |
Oesophageal varices haemorrhage
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Hepatobiliary disorders
|
|
|
Ascites
|
|
|
subjects affected / exposed
|
34 / 95 (35.79%) |
30 / 108 (27.78%) |
occurrences all number
|
37 |
40 |
Bile duct obstruction
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Biliary colic
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Caput medusae
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
3 / 108 (2.78%) |
occurrences all number
|
2 |
3 |
Cholecystitis
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Cholelithiasis
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Cholestasis
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
2 / 108 (1.85%) |
occurrences all number
|
0 |
2 |
Cirrhosis alcoholic
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Foetor hepaticus
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Gallbladder disorder
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
1 / 108 (0.93%) |
occurrences all number
|
2 |
1 |
Hepatic cirrhosis
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Hepatic failure
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
3 / 108 (2.78%) |
occurrences all number
|
3 |
3 |
Hepatic fibrosis
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Hepatitis alcoholic
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Hepatomegaly
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
2 / 108 (1.85%) |
occurrences all number
|
2 |
2 |
Hepatorenal syndrome
|
|
|
subjects affected / exposed
|
11 / 95 (11.58%) |
11 / 108 (10.19%) |
occurrences all number
|
12 |
13 |
Hyperammonaemia
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
0 / 108 (0.00%) |
occurrences all number
|
3 |
0 |
Jaundice
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
4 / 108 (3.70%) |
occurrences all number
|
2 |
4 |
Ocular icterus
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
3 / 108 (2.78%) |
occurrences all number
|
1 |
3 |
Portal hypertension
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
4 / 108 (3.70%) |
occurrences all number
|
2 |
4 |
Skin and subcutaneous tissue disorders
|
|
|
Acne
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Anogenital warts
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Blister
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
3 / 108 (2.78%) |
occurrences all number
|
0 |
3 |
Cellulitis
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
1 / 108 (0.93%) |
occurrences all number
|
2 |
1 |
Decubitus ulcer
|
|
|
subjects affected / exposed
|
5 / 95 (5.26%) |
0 / 108 (0.00%) |
occurrences all number
|
5 |
0 |
Dermatitis
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
2 |
0 |
Dry skin
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
5 / 108 (4.63%) |
occurrences all number
|
0 |
5 |
Ecchymosis
|
|
|
subjects affected / exposed
|
9 / 95 (9.47%) |
6 / 108 (5.56%) |
occurrences all number
|
9 |
9 |
Erythema
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
3 / 108 (2.78%) |
occurrences all number
|
3 |
4 |
Eschar
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Face oedema
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Facial wasting
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
4 / 108 (3.70%) |
occurrences all number
|
1 |
4 |
Folliculitis
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Herpes simplex
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Hyperhidrosis
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Hyperkeratosis
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Laceration
|
|
|
subjects affected / exposed
|
4 / 95 (4.21%) |
1 / 108 (0.93%) |
occurrences all number
|
4 |
1 |
Nail discolouration
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Night sweats
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
2 / 108 (1.85%) |
occurrences all number
|
1 |
2 |
Onychomycosis
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
2 / 108 (1.85%) |
occurrences all number
|
0 |
2 |
Palmar erythema
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
1 / 108 (0.93%) |
occurrences all number
|
3 |
1 |
Perianal erythema
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Pruritus
|
|
|
subjects affected / exposed
|
19 / 95 (20.00%) |
19 / 108 (17.59%) |
occurrences all number
|
20 |
20 |
Psoriasis
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Rash
|
|
|
subjects affected / exposed
|
7 / 95 (7.37%) |
11 / 108 (10.19%) |
occurrences all number
|
7 |
12 |
Rash pustular
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Scab
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Scratch
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
1 / 108 (0.93%) |
occurrences all number
|
3 |
1 |
Skin disorder
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
0 / 108 (0.00%) |
occurrences all number
|
3 |
0 |
Skin erosion
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Skin exfoliation
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Skin irritation
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Skin lesion
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Skin ulcer
|
|
|
subjects affected / exposed
|
5 / 95 (5.26%) |
3 / 108 (2.78%) |
occurrences all number
|
5 |
3 |
Stasis dermatitis
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Swelling face
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
0 / 108 (0.00%) |
occurrences all number
|
3 |
0 |
Renal and urinary disorders
|
|
|
Acute prerenal failure
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Anuria
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
0 / 108 (0.00%) |
occurrences all number
|
2 |
0 |
Azotaemia
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
3 / 108 (2.78%) |
occurrences all number
|
1 |
3 |
Costovertebral angle tenderness
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Cystitis
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Dysuria
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
1 / 108 (0.93%) |
occurrences all number
|
2 |
1 |
Haematuria
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
1 / 108 (0.93%) |
occurrences all number
|
2 |
1 |
Hydronephrosis
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Incontinence
|
|
|
subjects affected / exposed
|
4 / 95 (4.21%) |
0 / 108 (0.00%) |
occurrences all number
|
4 |
0 |
Micturition urgency
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
2 / 108 (1.85%) |
occurrences all number
|
0 |
2 |
Nephrolithiasis
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Nocturia
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Oliguria
|
|
|
subjects affected / exposed
|
6 / 95 (6.32%) |
0 / 108 (0.00%) |
occurrences all number
|
6 |
0 |
Polyuria
|
|
|
subjects affected / exposed
|
4 / 95 (4.21%) |
2 / 108 (1.85%) |
occurrences all number
|
4 |
2 |
Pyelonephritis
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Renal disorder
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Renal failure
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
1 / 108 (0.93%) |
occurrences all number
|
3 |
1 |
Renal failure acute
|
|
|
subjects affected / exposed
|
22 / 95 (23.16%) |
21 / 108 (19.44%) |
occurrences all number
|
23 |
25 |
Renal impairment
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Urethral pain
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Urinary incontinence
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
1 / 108 (0.93%) |
occurrences all number
|
2 |
1 |
Urinary retention
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
0 / 108 (0.00%) |
occurrences all number
|
2 |
0 |
Urinary tract pain
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Endocrine disorders
|
|
|
Diabetes mellitus
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Musculoskeletal and connective tissue disorders
|
|
|
Arthralgia
|
|
|
subjects affected / exposed
|
7 / 95 (7.37%) |
3 / 108 (2.78%) |
occurrences all number
|
7 |
3 |
Back pain
|
|
|
subjects affected / exposed
|
9 / 95 (9.47%) |
13 / 108 (12.04%) |
occurrences all number
|
12 |
16 |
Chills
|
|
|
subjects affected / exposed
|
4 / 95 (4.21%) |
3 / 108 (2.78%) |
occurrences all number
|
4 |
3 |
Groin pain
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
0 / 108 (0.00%) |
occurrences all number
|
2 |
0 |
Joint range of motion decreased
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Joint swelling
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Muscle atrophy
|
|
|
subjects affected / exposed
|
8 / 95 (8.42%) |
6 / 108 (5.56%) |
occurrences all number
|
8 |
6 |
Muscle spasms
|
|
|
subjects affected / exposed
|
5 / 95 (5.26%) |
3 / 108 (2.78%) |
occurrences all number
|
5 |
3 |
Musculoskeletal discomfort
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Musculoskeletal pain
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Musculoskeletal stiffness
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Myalgia
|
|
|
subjects affected / exposed
|
5 / 95 (5.26%) |
0 / 108 (0.00%) |
occurrences all number
|
5 |
0 |
Myopathy
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Neck pain
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
2 / 108 (1.85%) |
occurrences all number
|
3 |
2 |
Osteoarthritis
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Osteopenia
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Pain in extremity
|
|
|
subjects affected / exposed
|
7 / 95 (7.37%) |
4 / 108 (3.70%) |
occurrences all number
|
7 |
5 |
Rotator cuff syndrome
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Sarcopenia
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Spinal disorder
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Spinal osteoarthritis
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Muscular weakness
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
3 / 108 (2.78%) |
occurrences all number
|
1 |
3 |
Flank pain
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Infections and infestations
|
|
|
Aspergillosis
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Bacteraemia
|
|
|
subjects affected / exposed
|
16 / 95 (16.84%) |
7 / 108 (6.48%) |
occurrences all number
|
18 |
8 |
Candidiasis
|
|
|
subjects affected / exposed
|
9 / 95 (9.47%) |
3 / 108 (2.78%) |
occurrences all number
|
10 |
3 |
Candiduria
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Clostridial infection
|
|
|
subjects affected / exposed
|
4 / 95 (4.21%) |
6 / 108 (5.56%) |
occurrences all number
|
4 |
6 |
Clostridium difficile colitis
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Device related infection
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Diverticulitis
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Endocarditis
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Enterococcal infection
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
2 / 108 (1.85%) |
occurrences all number
|
2 |
2 |
Escherichia infection
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Fungaemia
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Fungal infection
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
2 / 108 (1.85%) |
occurrences all number
|
3 |
2 |
Fungal skin infection
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
1 / 108 (0.93%) |
occurrences all number
|
2 |
1 |
Gastroenteritis
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Helicobacter infection
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Infection
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Lyme disease
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Oesophageal candidiasis
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Oral candidiasis
|
|
|
subjects affected / exposed
|
8 / 95 (8.42%) |
6 / 108 (5.56%) |
occurrences all number
|
8 |
6 |
Oral herpes
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Paronychia
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Peritonitis bacterial
|
|
|
subjects affected / exposed
|
6 / 95 (6.32%) |
4 / 108 (3.70%) |
occurrences all number
|
6 |
4 |
Pharyngitis streptococcal
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Pneumonia
|
|
|
subjects affected / exposed
|
13 / 95 (13.68%) |
10 / 108 (9.26%) |
occurrences all number
|
13 |
10 |
Propionibacterium infection
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Respiratory tract infection
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Sepsis
|
|
|
subjects affected / exposed
|
7 / 95 (7.37%) |
7 / 108 (6.48%) |
occurrences all number
|
7 |
8 |
Septic encephalopathy
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Staphylococcal infection
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Tinea infection
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Tooth abscess
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Upper respiratory tract infection
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Urinary tract infection
|
|
|
subjects affected / exposed
|
14 / 95 (14.74%) |
16 / 108 (14.81%) |
occurrences all number
|
19 |
19 |
Viral infection
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Metabolism and nutrition disorders
|
|
|
Acidosis
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
2 / 108 (1.85%) |
occurrences all number
|
4 |
2 |
Adrenal insufficiency
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Cachexia
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
3 / 108 (2.78%) |
occurrences all number
|
1 |
3 |
Decreased appetite
|
|
|
subjects affected / exposed
|
7 / 95 (7.37%) |
7 / 108 (6.48%) |
occurrences all number
|
7 |
7 |
Dehydration
|
|
|
subjects affected / exposed
|
6 / 95 (6.32%) |
5 / 108 (4.63%) |
occurrences all number
|
6 |
6 |
Electrolyte imbalance
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Fluid overload
|
|
|
subjects affected / exposed
|
8 / 95 (8.42%) |
4 / 108 (3.70%) |
occurrences all number
|
8 |
4 |
Fluid retention
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
3 / 108 (2.78%) |
occurrences all number
|
1 |
4 |
Generalised oedema
|
|
|
subjects affected / exposed
|
9 / 95 (9.47%) |
4 / 108 (3.70%) |
occurrences all number
|
9 |
4 |
Goitre
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Hepatic steatosis
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
1 / 108 (0.93%) |
occurrences all number
|
2 |
1 |
Hyperbilirubinaemia
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Hypercalcaemia
|
|
|
subjects affected / exposed
|
2 / 95 (2.11%) |
1 / 108 (0.93%) |
occurrences all number
|
2 |
1 |
Hyperchloraemia
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
0 / 108 (0.00%) |
occurrences all number
|
3 |
0 |
Hyperglycaemia
|
|
|
subjects affected / exposed
|
19 / 95 (20.00%) |
10 / 108 (9.26%) |
occurrences all number
|
21 |
12 |
Hyperkalaemia
|
|
|
subjects affected / exposed
|
8 / 95 (8.42%) |
4 / 108 (3.70%) |
occurrences all number
|
8 |
6 |
Hypermagnesaemia
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Hypernatraemia
|
|
|
subjects affected / exposed
|
8 / 95 (8.42%) |
5 / 108 (4.63%) |
occurrences all number
|
8 |
5 |
Hyperphosphataemia
|
|
|
subjects affected / exposed
|
6 / 95 (6.32%) |
3 / 108 (2.78%) |
occurrences all number
|
7 |
3 |
Hypervolaemia
|
|
|
subjects affected / exposed
|
3 / 95 (3.16%) |
1 / 108 (0.93%) |
occurrences all number
|
3 |
1 |
Hypoalbuminaemia
|
|
|
subjects affected / exposed
|
4 / 95 (4.21%) |
7 / 108 (6.48%) |
occurrences all number
|
4 |
7 |
Hypocalcaemia
|
|
|
subjects affected / exposed
|
18 / 95 (18.95%) |
3 / 108 (2.78%) |
occurrences all number
|
24 |
5 |
Hypochloraemia
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Hypoglycaemia
|
|
|
subjects affected / exposed
|
6 / 95 (6.32%) |
4 / 108 (3.70%) |
occurrences all number
|
6 |
4 |
Hypokalaemia
|
|
|
subjects affected / exposed
|
21 / 95 (22.11%) |
29 / 108 (26.85%) |
occurrences all number
|
23 |
34 |
Hypomagnesaemia
|
|
|
subjects affected / exposed
|
21 / 95 (22.11%) |
14 / 108 (12.96%) |
occurrences all number
|
25 |
14 |
Hyponatraemia
|
|
|
subjects affected / exposed
|
8 / 95 (8.42%) |
15 / 108 (13.89%) |
occurrences all number
|
8 |
17 |
Hypophosphataemia
|
|
|
subjects affected / exposed
|
23 / 95 (24.21%) |
14 / 108 (12.96%) |
occurrences all number
|
23 |
14 |
Hypoproteinaemia
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Hypothyroidism
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Hypovolaemia
|
|
|
subjects affected / exposed
|
5 / 95 (5.26%) |
5 / 108 (4.63%) |
occurrences all number
|
5 |
5 |
Lactic acidosis
|
|
|
subjects affected / exposed
|
5 / 95 (5.26%) |
2 / 108 (1.85%) |
occurrences all number
|
7 |
2 |
Lactose intolerance
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Localised oedema
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
1 / 108 (0.93%) |
occurrences all number
|
1 |
1 |
Malnutrition
|
|
|
subjects affected / exposed
|
5 / 95 (5.26%) |
5 / 108 (4.63%) |
occurrences all number
|
5 |
5 |
Metabolic acidosis
|
|
|
subjects affected / exposed
|
16 / 95 (16.84%) |
13 / 108 (12.04%) |
occurrences all number
|
16 |
14 |
Metabolic alkalosis
|
|
|
subjects affected / exposed
|
1 / 95 (1.05%) |
0 / 108 (0.00%) |
occurrences all number
|
1 |
0 |
Oedema
|
|
|
subjects affected / exposed
|
9 / 95 (9.47%) |
12 / 108 (11.11%) |
occurrences all number
|
9 |
15 |
Osteoporosis
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Vitamin D deficiency
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
1 / 108 (0.93%) |
occurrences all number
|
0 |
1 |
Zinc deficiency
|
|
|
subjects affected / exposed
|
0 / 95 (0.00%) |
4 / 108 (3.70%) |
occurrences all number
|
0 |
4 |