Non-serious adverse events
|
Nivolumab |
Placebo |
Total subjects affected by non serious adverse events
|
|
|
subjects affected / exposed
|
204 / 221 (92.31%) |
97 / 111 (87.39%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Cancer pain
|
|
|
Additional description: Cancer pain
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Basal cell carcinoma
|
|
|
Additional description: Basal cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Vascular disorders
|
|
|
Phlebitis
|
|
|
Additional description: Phlebitis
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Peripheral coldness
|
|
|
Additional description: Peripheral coldness
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Brachiocephalic vein thrombosis
|
|
|
Additional description: Brachiocephalic vein thrombosis
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Orthostatic hypotension
|
|
|
Additional description: Orthostatic hypotension
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Embolism
|
|
|
Additional description: Embolism
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Hot flush
|
|
|
Additional description: Hot flush
|
|
|
subjects affected / exposed
|
9 / 221 (4.07%) |
1 / 111 (0.90%) |
occurrences all number
|
9 |
1 |
Raynaud's phenomenon
|
|
|
Additional description: Raynaud's phenomenon
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Hypotension
|
|
|
Additional description: Hypotension
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
0 / 111 (0.00%) |
occurrences all number
|
2 |
0 |
Angiopathy
|
|
|
Additional description: Angiopathy
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Superior vena cava occlusion
|
|
|
Additional description: Superior vena cava occlusion
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Ischaemia
|
|
|
Additional description: Ischaemia
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Hypertension
|
|
|
Additional description: Hypertension
|
|
|
subjects affected / exposed
|
5 / 221 (2.26%) |
4 / 111 (3.60%) |
occurrences all number
|
7 |
5 |
General disorders and administration site conditions
|
|
|
Catheter site rash
|
|
|
Additional description: Catheter site rash
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Oedema peripheral
|
|
|
Additional description: Oedema peripheral
|
|
|
subjects affected / exposed
|
11 / 221 (4.98%) |
2 / 111 (1.80%) |
occurrences all number
|
12 |
2 |
Catheter site hypersensitivity
|
|
|
Additional description: Catheter site hypersensitivity
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Pyrexia
|
|
|
Additional description: Pyrexia
|
|
|
subjects affected / exposed
|
11 / 221 (4.98%) |
4 / 111 (3.60%) |
occurrences all number
|
11 |
5 |
Hyperthermia
|
|
|
Additional description: Hyperthermia
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Swelling
|
|
|
Additional description: Swelling
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
1 / 111 (0.90%) |
occurrences all number
|
3 |
1 |
Adverse reaction
|
|
|
Additional description: Adverse reaction
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Catheter site erythema
|
|
|
Additional description: Catheter site erythema
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Effusion
|
|
|
Additional description: Effusion
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Chest pain
|
|
|
Additional description: Chest pain
|
|
|
subjects affected / exposed
|
17 / 221 (7.69%) |
8 / 111 (7.21%) |
occurrences all number
|
21 |
11 |
Catheter site pruritus
|
|
|
Additional description: Catheter site pruritus
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Adverse drug reaction
|
|
|
Additional description: Adverse drug reaction
|
|
|
subjects affected / exposed
|
4 / 221 (1.81%) |
0 / 111 (0.00%) |
occurrences all number
|
6 |
0 |
Mass
|
|
|
Additional description: Mass
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
0 / 111 (0.00%) |
occurrences all number
|
2 |
0 |
Chills
|
|
|
Additional description: Chills
|
|
|
subjects affected / exposed
|
5 / 221 (2.26%) |
0 / 111 (0.00%) |
occurrences all number
|
5 |
0 |
Mucosal inflammation
|
|
|
Additional description: Mucosal inflammation
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
0 / 111 (0.00%) |
occurrences all number
|
3 |
0 |
Generalised oedema
|
|
|
Additional description: Generalised oedema
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Chest discomfort
|
|
|
Additional description: Chest discomfort
|
|
|
subjects affected / exposed
|
4 / 221 (1.81%) |
2 / 111 (1.80%) |
occurrences all number
|
4 |
2 |
Influenza like illness
|
|
|
Additional description: Influenza like illness
|
|
|
subjects affected / exposed
|
7 / 221 (3.17%) |
4 / 111 (3.60%) |
occurrences all number
|
7 |
4 |
Malaise
|
|
|
Additional description: Malaise
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
0 / 111 (0.00%) |
occurrences all number
|
3 |
0 |
Non-cardiac chest pain
|
|
|
Additional description: Non-cardiac chest pain
|
|
|
subjects affected / exposed
|
18 / 221 (8.14%) |
8 / 111 (7.21%) |
occurrences all number
|
18 |
9 |
Facial pain
|
|
|
Additional description: Facial pain
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Catheter site phlebitis
|
|
|
Additional description: Catheter site phlebitis
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Cyst
|
|
|
Additional description: Cyst
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Asthenia
|
|
|
Additional description: Asthenia
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
1 / 111 (0.90%) |
occurrences all number
|
1 |
1 |
Pain
|
|
|
Additional description: Pain
|
|
|
subjects affected / exposed
|
21 / 221 (9.50%) |
5 / 111 (4.50%) |
occurrences all number
|
22 |
6 |
Feeling cold
|
|
|
Additional description: Feeling cold
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Axillary pain
|
|
|
Additional description: Axillary pain
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
0 / 111 (0.00%) |
occurrences all number
|
2 |
0 |
Vaccination site pain
|
|
|
Additional description: Vaccination site pain
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Gait disturbance
|
|
|
Additional description: Gait disturbance
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Early satiety
|
|
|
Additional description: Early satiety
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Fatigue
|
|
|
Additional description: Fatigue
|
|
|
subjects affected / exposed
|
85 / 221 (38.46%) |
33 / 111 (29.73%) |
occurrences all number
|
100 |
35 |
General physical health deterioration
|
|
|
Additional description: General physical health deterioration
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Infusion site hypoaesthesia
|
|
|
Additional description: Infusion site hypoaesthesia
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Medical device site nodule
|
|
|
Additional description: Medical device site nodule
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Peripheral swelling
|
|
|
Additional description: Peripheral swelling
|
|
|
subjects affected / exposed
|
3 / 221 (1.36%) |
3 / 111 (2.70%) |
occurrences all number
|
3 |
4 |
Immune system disorders
|
|
|
Seasonal allergy
|
|
|
Additional description: Seasonal allergy
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
2 |
0 |
Hypersensitivity
|
|
|
Additional description: Hypersensitivity
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
1 / 111 (0.90%) |
occurrences all number
|
2 |
2 |
Autoimmune disorder
|
|
|
Additional description: Autoimmune disorder
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Reproductive system and breast disorders
|
|
|
Genital rash
|
|
|
Additional description: Genital rash
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Penile rash
|
|
|
Additional description: Penile rash
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Breast mass
|
|
|
Additional description: Breast mass
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Nipple pain
|
|
|
Additional description: Nipple pain
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Respiratory, thoracic and mediastinal disorders
|
|
|
Bronchial obstruction
|
|
|
Additional description: Bronchial obstruction
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Dyspnoea
|
|
|
Additional description: Dyspnoea
|
|
|
subjects affected / exposed
|
66 / 221 (29.86%) |
28 / 111 (25.23%) |
occurrences all number
|
74 |
32 |
Dry throat
|
|
|
Additional description: Dry throat
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Choking
|
|
|
Additional description: Choking
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Pneumonitis
|
|
|
Additional description: Pneumonitis
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
0 / 111 (0.00%) |
occurrences all number
|
2 |
0 |
Productive cough
|
|
|
Additional description: Productive cough
|
|
|
subjects affected / exposed
|
7 / 221 (3.17%) |
2 / 111 (1.80%) |
occurrences all number
|
7 |
2 |
Wheezing
|
|
|
Additional description: Wheezing
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
1 / 111 (0.90%) |
occurrences all number
|
1 |
1 |
Pleuritic pain
|
|
|
Additional description: Pleuritic pain
|
|
|
subjects affected / exposed
|
3 / 221 (1.36%) |
1 / 111 (0.90%) |
occurrences all number
|
3 |
1 |
Nasal congestion
|
|
|
Additional description: Nasal congestion
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
1 / 111 (0.90%) |
occurrences all number
|
1 |
1 |
Sputum discoloured
|
|
|
Additional description: Sputum discoloured
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Increased bronchial secretion
|
|
|
Additional description: Increased bronchial secretion
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Haemoptysis
|
|
|
Additional description: Haemoptysis
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
2 / 111 (1.80%) |
occurrences all number
|
2 |
2 |
Rhinorrhoea
|
|
|
Additional description: Rhinorrhoea
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Oropharyngeal pain
|
|
|
Additional description: Oropharyngeal pain
|
|
|
subjects affected / exposed
|
6 / 221 (2.71%) |
2 / 111 (1.80%) |
occurrences all number
|
6 |
2 |
Stridor
|
|
|
Additional description: Stridor
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Hypoxia
|
|
|
Additional description: Hypoxia
|
|
|
subjects affected / exposed
|
3 / 221 (1.36%) |
0 / 111 (0.00%) |
occurrences all number
|
3 |
0 |
Pleural effusion
|
|
|
Additional description: Pleural effusion
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
1 / 111 (0.90%) |
occurrences all number
|
1 |
2 |
Chronic obstructive pulmonary disease
|
|
|
Additional description: Chronic obstructive pulmonary disease
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
0 / 111 (0.00%) |
occurrences all number
|
2 |
0 |
Cough
|
|
|
Additional description: Cough
|
|
|
subjects affected / exposed
|
41 / 221 (18.55%) |
21 / 111 (18.92%) |
occurrences all number
|
48 |
22 |
Pulmonary embolism
|
|
|
Additional description: Pulmonary embolism
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
3 / 111 (2.70%) |
occurrences all number
|
2 |
3 |
Asthma
|
|
|
Additional description: Asthma
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Increased viscosity of bronchial secretion
|
|
|
Additional description: Increased viscosity of bronchial secretion
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Epistaxis
|
|
|
Additional description: Epistaxis
|
|
|
subjects affected / exposed
|
8 / 221 (3.62%) |
1 / 111 (0.90%) |
occurrences all number
|
8 |
1 |
Dysphonia
|
|
|
Additional description: Dysphonia
|
|
|
subjects affected / exposed
|
5 / 221 (2.26%) |
1 / 111 (0.90%) |
occurrences all number
|
5 |
1 |
Pneumothorax
|
|
|
Additional description: Pneumothorax
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Psychiatric disorders
|
|
|
Depression
|
|
|
Additional description: Depression
|
|
|
subjects affected / exposed
|
6 / 221 (2.71%) |
2 / 111 (1.80%) |
occurrences all number
|
6 |
2 |
Abnormal dreams
|
|
|
Additional description: Abnormal dreams
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Anxiety
|
|
|
Additional description: Anxiety
|
|
|
subjects affected / exposed
|
5 / 221 (2.26%) |
1 / 111 (0.90%) |
occurrences all number
|
5 |
1 |
Agitation
|
|
|
Additional description: Agitation
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Confusional state
|
|
|
Additional description: Confusional state
|
|
|
subjects affected / exposed
|
3 / 221 (1.36%) |
1 / 111 (0.90%) |
occurrences all number
|
3 |
1 |
Insomnia
|
|
|
Additional description: Insomnia
|
|
|
subjects affected / exposed
|
12 / 221 (5.43%) |
3 / 111 (2.70%) |
occurrences all number
|
12 |
3 |
Depressed mood
|
|
|
Additional description: Depressed mood
|
|
|
subjects affected / exposed
|
5 / 221 (2.26%) |
2 / 111 (1.80%) |
occurrences all number
|
5 |
2 |
Irritability
|
|
|
Additional description: Irritability
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
2 |
0 |
Hallucination
|
|
|
Additional description: Hallucination
|
|
|
subjects affected / exposed
|
3 / 221 (1.36%) |
1 / 111 (0.90%) |
occurrences all number
|
3 |
1 |
Investigations
|
|
|
Haematocrit decreased
|
|
|
Additional description: Haematocrit decreased
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
0 / 111 (0.00%) |
occurrences all number
|
2 |
0 |
Blood bilirubin increased
|
|
|
Additional description: Blood bilirubin increased
|
|
|
subjects affected / exposed
|
4 / 221 (1.81%) |
1 / 111 (0.90%) |
occurrences all number
|
6 |
1 |
Thyroxine decreased
|
|
|
Additional description: Thyroxine decreased
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
0 / 111 (0.00%) |
occurrences all number
|
2 |
0 |
Tri-iodothyronine free increased
|
|
|
Additional description: Tri-iodothyronine free increased
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
White blood cell count increased
|
|
|
Additional description: White blood cell count increased
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
2 |
0 |
Blood phosphorus decreased
|
|
|
Additional description: Blood phosphorus decreased
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
0 / 111 (0.00%) |
occurrences all number
|
2 |
0 |
C-reactive protein increased
|
|
|
Additional description: C-reactive protein increased
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
2 / 111 (1.80%) |
occurrences all number
|
2 |
2 |
Blood thyroid stimulating hormone decreased
|
|
|
Additional description: Blood thyroid stimulating hormone decreased
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
0 / 111 (0.00%) |
occurrences all number
|
2 |
0 |
Blood urea increased
|
|
|
Additional description: Blood urea increased
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
0 / 111 (0.00%) |
occurrences all number
|
2 |
0 |
Creatinine renal clearance decreased
|
|
|
Additional description: Creatinine renal clearance decreased
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Amylase increased
|
|
|
Additional description: Amylase increased
|
|
|
subjects affected / exposed
|
6 / 221 (2.71%) |
1 / 111 (0.90%) |
occurrences all number
|
7 |
2 |
Lymphocyte count decreased
|
|
|
Additional description: Lymphocyte count decreased
|
|
|
subjects affected / exposed
|
4 / 221 (1.81%) |
0 / 111 (0.00%) |
occurrences all number
|
6 |
0 |
Tri-iodothyronine increased
|
|
|
Additional description: Tri-iodothyronine increased
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Aspartate aminotransferase increased
|
|
|
Additional description: Aspartate aminotransferase increased
|
|
|
subjects affected / exposed
|
7 / 221 (3.17%) |
0 / 111 (0.00%) |
occurrences all number
|
7 |
0 |
Transaminases increased
|
|
|
Additional description: Transaminases increased
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Tri-iodothyronine decreased
|
|
|
Additional description: Tri-iodothyronine decreased
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Neutrophil count increased
|
|
|
Additional description: Neutrophil count increased
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Tri-iodothyronine free decreased
|
|
|
Additional description: Tri-iodothyronine free decreased
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
0 / 111 (0.00%) |
occurrences all number
|
3 |
0 |
Platelet count increased
|
|
|
Additional description: Platelet count increased
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Blood potassium decreased
|
|
|
Additional description: Blood potassium decreased
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
1 / 111 (0.90%) |
occurrences all number
|
1 |
1 |
Blood calcium decreased
|
|
|
Additional description: Blood calcium decreased
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Blood testosterone decreased
|
|
|
Additional description: Blood testosterone decreased
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
2 / 111 (1.80%) |
occurrences all number
|
0 |
2 |
Blood phosphorus increased
|
|
|
Additional description: Blood phosphorus increased
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Blood thyroid stimulating hormone increased
|
|
|
Additional description: Blood thyroid stimulating hormone increased
|
|
|
subjects affected / exposed
|
4 / 221 (1.81%) |
0 / 111 (0.00%) |
occurrences all number
|
6 |
0 |
Thyroxine free increased
|
|
|
Additional description: Thyroxine free increased
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Weight decreased
|
|
|
Additional description: Weight decreased
|
|
|
subjects affected / exposed
|
12 / 221 (5.43%) |
9 / 111 (8.11%) |
occurrences all number
|
13 |
9 |
Thyroxine free decreased
|
|
|
Additional description: Thyroxine free decreased
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Haemoglobin decreased
|
|
|
Additional description: Haemoglobin decreased
|
|
|
subjects affected / exposed
|
3 / 221 (1.36%) |
0 / 111 (0.00%) |
occurrences all number
|
3 |
0 |
Alanine aminotransferase increased
|
|
|
Additional description: Alanine aminotransferase increased
|
|
|
subjects affected / exposed
|
9 / 221 (4.07%) |
1 / 111 (0.90%) |
occurrences all number
|
9 |
1 |
Blood alkaline phosphatase increased
|
|
|
Additional description: Blood alkaline phosphatase increased
|
|
|
subjects affected / exposed
|
8 / 221 (3.62%) |
0 / 111 (0.00%) |
occurrences all number
|
10 |
0 |
Blood magnesium decreased
|
|
|
Additional description: Blood magnesium decreased
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Gamma-glutamyltransferase increased
|
|
|
Additional description: Gamma-glutamyltransferase increased
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Blood creatinine increased
|
|
|
Additional description: Blood creatinine increased
|
|
|
subjects affected / exposed
|
3 / 221 (1.36%) |
2 / 111 (1.80%) |
occurrences all number
|
3 |
4 |
Blood creatine phosphokinase
|
|
|
Additional description: Blood creatine phosphokinase
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Protein total decreased
|
|
|
Additional description: Protein total decreased
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Lipase increased
|
|
|
Additional description: Lipase increased
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Injury, poisoning and procedural complications
|
|
|
Radiation skin injury
|
|
|
Additional description: Radiation skin injury
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Arthropod bite
|
|
|
Additional description: Arthropod bite
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Procedural pain
|
|
|
Additional description: Procedural pain
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
1 / 111 (0.90%) |
occurrences all number
|
1 |
1 |
Contusion
|
|
|
Additional description: Contusion
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Skin laceration
|
|
|
Additional description: Skin laceration
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Hand fracture
|
|
|
Additional description: Hand fracture
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Muscle strain
|
|
|
Additional description: Muscle strain
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Face injury
|
|
|
Additional description: Face injury
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Thoracic vertebral fracture
|
|
|
Additional description: Thoracic vertebral fracture
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Fall
|
|
|
Additional description: Fall
|
|
|
subjects affected / exposed
|
8 / 221 (3.62%) |
2 / 111 (1.80%) |
occurrences all number
|
8 |
2 |
Road traffic accident
|
|
|
Additional description: Road traffic accident
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Infusion related reaction
|
|
|
Additional description: Infusion related reaction
|
|
|
subjects affected / exposed
|
14 / 221 (6.33%) |
0 / 111 (0.00%) |
occurrences all number
|
17 |
0 |
Cardiac disorders
|
|
|
Sinus tachycardia
|
|
|
Additional description: Sinus tachycardia
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Tachycardia
|
|
|
Additional description: Tachycardia
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
1 / 111 (0.90%) |
occurrences all number
|
1 |
1 |
Bradycardia
|
|
|
Additional description: Bradycardia
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Cardiac dysfunction
|
|
|
Additional description: Cardiac dysfunction
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Pericardial effusion
|
|
|
Additional description: Pericardial effusion
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Atrial fibrillation
|
|
|
Additional description: Atrial fibrillation
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
2 / 111 (1.80%) |
occurrences all number
|
1 |
2 |
Extrasystoles
|
|
|
Additional description: Extrasystoles
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Palpitations
|
|
|
Additional description: Palpitations
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
2 |
0 |
Nervous system disorders
|
|
|
Peripheral motor neuropathy
|
|
|
Additional description: Peripheral motor neuropathy
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Syncope
|
|
|
Additional description: Syncope
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
1 / 111 (0.90%) |
occurrences all number
|
1 |
1 |
Paraesthesia
|
|
|
Additional description: Paraesthesia
|
|
|
subjects affected / exposed
|
3 / 221 (1.36%) |
1 / 111 (0.90%) |
occurrences all number
|
3 |
1 |
Drooling
|
|
|
Additional description: Drooling
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Lethargy
|
|
|
Additional description: Lethargy
|
|
|
subjects affected / exposed
|
12 / 221 (5.43%) |
6 / 111 (5.41%) |
occurrences all number
|
14 |
6 |
Headache
|
|
|
Additional description: Headache
|
|
|
subjects affected / exposed
|
13 / 221 (5.88%) |
4 / 111 (3.60%) |
occurrences all number
|
20 |
5 |
Burning sensation
|
|
|
Additional description: Burning sensation
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Dizziness postural
|
|
|
Additional description: Dizziness postural
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Taste disorder
|
|
|
Additional description: Taste disorder
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
1 / 111 (0.90%) |
occurrences all number
|
2 |
1 |
Neuralgia
|
|
|
Additional description: Neuralgia
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
1 / 111 (0.90%) |
occurrences all number
|
2 |
1 |
Carpal tunnel syndrome
|
|
|
Additional description: Carpal tunnel syndrome
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Peroneal nerve palsy
|
|
|
Additional description: Peroneal nerve palsy
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Seizure
|
|
|
Additional description: Seizure
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Hypoaesthesia
|
|
|
Additional description: Hypoaesthesia
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Dizziness
|
|
|
Additional description: Dizziness
|
|
|
subjects affected / exposed
|
11 / 221 (4.98%) |
2 / 111 (1.80%) |
occurrences all number
|
11 |
2 |
Balance disorder
|
|
|
Additional description: Balance disorder
|
|
|
subjects affected / exposed
|
4 / 221 (1.81%) |
0 / 111 (0.00%) |
occurrences all number
|
4 |
0 |
Neuropathy peripheral
|
|
|
Additional description: Neuropathy peripheral
|
|
|
subjects affected / exposed
|
6 / 221 (2.71%) |
1 / 111 (0.90%) |
occurrences all number
|
6 |
1 |
Anosmia
|
|
|
Additional description: Anosmia
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Migraine
|
|
|
Additional description: Migraine
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Trigeminal neuralgia
|
|
|
Additional description: Trigeminal neuralgia
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Somnolence
|
|
|
Additional description: Somnolence
|
|
|
subjects affected / exposed
|
4 / 221 (1.81%) |
0 / 111 (0.00%) |
occurrences all number
|
4 |
0 |
Tremor
|
|
|
Additional description: Tremor
|
|
|
subjects affected / exposed
|
3 / 221 (1.36%) |
0 / 111 (0.00%) |
occurrences all number
|
3 |
0 |
Hypersomnia
|
|
|
Additional description: Hypersomnia
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Dysgeusia
|
|
|
Additional description: Dysgeusia
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
2 / 111 (1.80%) |
occurrences all number
|
1 |
2 |
Spinal cord compression
|
|
|
Additional description: Spinal cord compression
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
1 / 111 (0.90%) |
occurrences all number
|
2 |
1 |
Peripheral sensory neuropathy
|
|
|
Additional description: Peripheral sensory neuropathy
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Blood and lymphatic system disorders
|
|
|
Thrombocytopenia
|
|
|
Additional description: Thrombocytopenia
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Lymphadenopathy
|
|
|
Additional description: Lymphadenopathy
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
0 / 111 (0.00%) |
occurrences all number
|
2 |
0 |
Neutropenia
|
|
|
Additional description: Neutropenia
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Anaemia
|
|
|
Additional description: Anaemia
|
|
|
subjects affected / exposed
|
22 / 221 (9.95%) |
4 / 111 (3.60%) |
occurrences all number
|
29 |
5 |
Ear and labyrinth disorders
|
|
|
Vertigo
|
|
|
Additional description: Vertigo
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Hypoacusis
|
|
|
Additional description: Hypoacusis
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Ear pain
|
|
|
Additional description: Ear pain
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
2 / 111 (1.80%) |
occurrences all number
|
0 |
2 |
Cerumen impaction
|
|
|
Additional description: Cerumen impaction
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Eye disorders
|
|
|
Glare
|
|
|
Additional description: Glare
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Dry eye
|
|
|
Additional description: Dry eye
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
3 / 111 (2.70%) |
occurrences all number
|
1 |
3 |
Lacrimation increased
|
|
|
Additional description: Lacrimation increased
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Vision blurred
|
|
|
Additional description: Vision blurred
|
|
|
subjects affected / exposed
|
4 / 221 (1.81%) |
2 / 111 (1.80%) |
occurrences all number
|
4 |
2 |
Macular oedema
|
|
|
Additional description: Macular oedema
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
2 |
Blepharitis
|
|
|
Additional description: Blepharitis
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Eye swelling
|
|
|
Additional description: Eye swelling
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Eye pruritus
|
|
|
Additional description: Eye pruritus
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Visual impairment
|
|
|
Additional description: Visual impairment
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Eye pain
|
|
|
Additional description: Eye pain
|
|
|
subjects affected / exposed
|
3 / 221 (1.36%) |
0 / 111 (0.00%) |
occurrences all number
|
3 |
0 |
Photopsia
|
|
|
Additional description: Photopsia
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Cystoid macular oedema
|
|
|
Additional description: Cystoid macular oedema
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Eye irritation
|
|
|
Additional description: Eye irritation
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Foreign body sensation in eyes
|
|
|
Additional description: Foreign body sensation in eyes
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Uveitis
|
|
|
Additional description: Uveitis
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Gastrointestinal disorders
|
|
|
Constipation
|
|
|
Additional description: Constipation
|
|
|
subjects affected / exposed
|
60 / 221 (27.15%) |
27 / 111 (24.32%) |
occurrences all number
|
69 |
29 |
Paraesthesia oral
|
|
|
Additional description: Paraesthesia oral
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
0 / 111 (0.00%) |
occurrences all number
|
2 |
0 |
Hiatus hernia
|
|
|
Additional description: Hiatus hernia
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Abdominal mass
|
|
|
Additional description: Abdominal mass
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Abdominal pain lower
|
|
|
Additional description: Abdominal pain lower
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
1 / 111 (0.90%) |
occurrences all number
|
1 |
1 |
Glossodynia
|
|
|
Additional description: Glossodynia
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Toothache
|
|
|
Additional description: Toothache
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Anal incontinence
|
|
|
Additional description: Anal incontinence
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Nausea
|
|
|
Additional description: Nausea
|
|
|
subjects affected / exposed
|
47 / 221 (21.27%) |
23 / 111 (20.72%) |
occurrences all number
|
66 |
24 |
Frequent bowel movements
|
|
|
Additional description: Frequent bowel movements
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Abdominal pain
|
|
|
Additional description: Abdominal pain
|
|
|
subjects affected / exposed
|
6 / 221 (2.71%) |
6 / 111 (5.41%) |
occurrences all number
|
6 |
7 |
Tongue ulceration
|
|
|
Additional description: Tongue ulceration
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Rectal haemorrhage
|
|
|
Additional description: Rectal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Proctalgia
|
|
|
Additional description: Proctalgia
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
1 / 111 (0.90%) |
occurrences all number
|
1 |
1 |
Diarrhoea
|
|
|
Additional description: Diarrhoea
|
|
|
subjects affected / exposed
|
41 / 221 (18.55%) |
17 / 111 (15.32%) |
occurrences all number
|
66 |
29 |
Haemorrhoids
|
|
|
Additional description: Haemorrhoids
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Mouth ulceration
|
|
|
Additional description: Mouth ulceration
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
1 / 111 (0.90%) |
occurrences all number
|
2 |
1 |
Dry mouth
|
|
|
Additional description: Dry mouth
|
|
|
subjects affected / exposed
|
8 / 221 (3.62%) |
8 / 111 (7.21%) |
occurrences all number
|
8 |
8 |
Oral pain
|
|
|
Additional description: Oral pain
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Stomatitis
|
|
|
Additional description: Stomatitis
|
|
|
subjects affected / exposed
|
8 / 221 (3.62%) |
1 / 111 (0.90%) |
occurrences all number
|
9 |
1 |
Flatulence
|
|
|
Additional description: Flatulence
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Gastrooesophageal reflux disease
|
|
|
Additional description: Gastrooesophageal reflux disease
|
|
|
subjects affected / exposed
|
6 / 221 (2.71%) |
0 / 111 (0.00%) |
occurrences all number
|
6 |
0 |
Abdominal discomfort
|
|
|
Additional description: Abdominal discomfort
|
|
|
subjects affected / exposed
|
5 / 221 (2.26%) |
1 / 111 (0.90%) |
occurrences all number
|
5 |
1 |
Dysphagia
|
|
|
Additional description: Dysphagia
|
|
|
subjects affected / exposed
|
3 / 221 (1.36%) |
3 / 111 (2.70%) |
occurrences all number
|
3 |
3 |
Tongue haemorrhage
|
|
|
Additional description: Tongue haemorrhage
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Dyspepsia
|
|
|
Additional description: Dyspepsia
|
|
|
subjects affected / exposed
|
6 / 221 (2.71%) |
4 / 111 (3.60%) |
occurrences all number
|
6 |
4 |
Haematemesis
|
|
|
Additional description: Haematemesis
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Lip dry
|
|
|
Additional description: Lip dry
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Colitis
|
|
|
Additional description: Colitis
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
1 / 111 (0.90%) |
occurrences all number
|
1 |
2 |
Pancreatitis
|
|
|
Additional description: Pancreatitis
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Abdominal pain upper
|
|
|
Additional description: Abdominal pain upper
|
|
|
subjects affected / exposed
|
4 / 221 (1.81%) |
2 / 111 (1.80%) |
occurrences all number
|
4 |
2 |
Hyperaesthesia teeth
|
|
|
Additional description: Hyperaesthesia teeth
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Gingival pain
|
|
|
Additional description: Gingival pain
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Melaena
|
|
|
Additional description: Melaena
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
1 / 111 (0.90%) |
occurrences all number
|
1 |
1 |
Swollen tongue
|
|
|
Additional description: Swollen tongue
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Ascites
|
|
|
Additional description: Ascites
|
|
|
subjects affected / exposed
|
6 / 221 (2.71%) |
2 / 111 (1.80%) |
occurrences all number
|
8 |
2 |
Abdominal distension
|
|
|
Additional description: Abdominal distension
|
|
|
subjects affected / exposed
|
5 / 221 (2.26%) |
4 / 111 (3.60%) |
occurrences all number
|
6 |
5 |
Vomiting
|
|
|
Additional description: Vomiting
|
|
|
subjects affected / exposed
|
25 / 221 (11.31%) |
9 / 111 (8.11%) |
occurrences all number
|
28 |
10 |
Hepatobiliary disorders
|
|
|
Hepatotoxicity
|
|
|
Additional description: Hepatotoxicity
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
0 / 111 (0.00%) |
occurrences all number
|
2 |
0 |
Skin and subcutaneous tissue disorders
|
|
|
Alopecia
|
|
|
Additional description: Alopecia
|
|
|
subjects affected / exposed
|
4 / 221 (1.81%) |
0 / 111 (0.00%) |
occurrences all number
|
4 |
0 |
Rash
|
|
|
Additional description: Rash
|
|
|
subjects affected / exposed
|
27 / 221 (12.22%) |
4 / 111 (3.60%) |
occurrences all number
|
35 |
5 |
Rash erythematous
|
|
|
Additional description: Rash erythematous
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Dry skin
|
|
|
Additional description: Dry skin
|
|
|
subjects affected / exposed
|
11 / 221 (4.98%) |
4 / 111 (3.60%) |
occurrences all number
|
11 |
4 |
Lichen planus
|
|
|
Additional description: Lichen planus
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Erythema
|
|
|
Additional description: Erythema
|
|
|
subjects affected / exposed
|
3 / 221 (1.36%) |
0 / 111 (0.00%) |
occurrences all number
|
4 |
0 |
Urticaria
|
|
|
Additional description: Urticaria
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
1 / 111 (0.90%) |
occurrences all number
|
1 |
1 |
Night sweats
|
|
|
Additional description: Night sweats
|
|
|
subjects affected / exposed
|
7 / 221 (3.17%) |
4 / 111 (3.60%) |
occurrences all number
|
7 |
4 |
Decubitus ulcer
|
|
|
Additional description: Decubitus ulcer
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Rash pruritic
|
|
|
Additional description: Rash pruritic
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
0 / 111 (0.00%) |
occurrences all number
|
3 |
0 |
Psoriasis
|
|
|
Additional description: Psoriasis
|
|
|
subjects affected / exposed
|
3 / 221 (1.36%) |
0 / 111 (0.00%) |
occurrences all number
|
3 |
0 |
Rash maculo-papular
|
|
|
Additional description: Rash maculo-papular
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
0 / 111 (0.00%) |
occurrences all number
|
2 |
0 |
Skin disorder
|
|
|
Additional description: Skin disorder
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Photosensitivity reaction
|
|
|
Additional description: Photosensitivity reaction
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Hyperhidrosis
|
|
|
Additional description: Hyperhidrosis
|
|
|
subjects affected / exposed
|
3 / 221 (1.36%) |
3 / 111 (2.70%) |
occurrences all number
|
3 |
3 |
Pain of skin
|
|
|
Additional description: Pain of skin
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Pruritus
|
|
|
Additional description: Pruritus
|
|
|
subjects affected / exposed
|
28 / 221 (12.67%) |
11 / 111 (9.91%) |
occurrences all number
|
31 |
14 |
Renal and urinary disorders
|
|
|
Haematuria
|
|
|
Additional description: Haematuria
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
1 / 111 (0.90%) |
occurrences all number
|
2 |
3 |
Urinary incontinence
|
|
|
Additional description: Urinary incontinence
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Urinary retention
|
|
|
Additional description: Urinary retention
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Dysuria
|
|
|
Additional description: Dysuria
|
|
|
subjects affected / exposed
|
3 / 221 (1.36%) |
0 / 111 (0.00%) |
occurrences all number
|
3 |
0 |
Chromaturia
|
|
|
Additional description: Chromaturia
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Nocturia
|
|
|
Additional description: Nocturia
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
0 / 111 (0.00%) |
occurrences all number
|
3 |
0 |
Proteinuria
|
|
|
Additional description: Proteinuria
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Renal vein thrombosis
|
|
|
Additional description: Renal vein thrombosis
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Pollakiuria
|
|
|
Additional description: Pollakiuria
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Renal impairment
|
|
|
Additional description: Renal impairment
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Acute kidney injury
|
|
|
Additional description: Acute kidney injury
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
0 / 111 (0.00%) |
occurrences all number
|
2 |
0 |
Endocrine disorders
|
|
|
Hypothyroidism
|
|
|
Additional description: Hypothyroidism
|
|
|
subjects affected / exposed
|
12 / 221 (5.43%) |
1 / 111 (0.90%) |
occurrences all number
|
12 |
1 |
Hyperthyroidism
|
|
|
Additional description: Hyperthyroidism
|
|
|
subjects affected / exposed
|
3 / 221 (1.36%) |
0 / 111 (0.00%) |
occurrences all number
|
3 |
0 |
Musculoskeletal and connective tissue disorders
|
|
|
Flank pain
|
|
|
Additional description: Flank pain
|
|
|
subjects affected / exposed
|
3 / 221 (1.36%) |
3 / 111 (2.70%) |
occurrences all number
|
3 |
3 |
Pain in jaw
|
|
|
Additional description: Pain in jaw
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Musculoskeletal stiffness
|
|
|
Additional description: Musculoskeletal stiffness
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Musculoskeletal chest pain
|
|
|
Additional description: Musculoskeletal chest pain
|
|
|
subjects affected / exposed
|
12 / 221 (5.43%) |
2 / 111 (1.80%) |
occurrences all number
|
14 |
3 |
Musculoskeletal pain
|
|
|
Additional description: Musculoskeletal pain
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Myalgia
|
|
|
Additional description: Myalgia
|
|
|
subjects affected / exposed
|
9 / 221 (4.07%) |
2 / 111 (1.80%) |
occurrences all number
|
9 |
2 |
Inguinal mass
|
|
|
Additional description: Inguinal mass
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Neck pain
|
|
|
Additional description: Neck pain
|
|
|
subjects affected / exposed
|
4 / 221 (1.81%) |
1 / 111 (0.90%) |
occurrences all number
|
4 |
1 |
Limb discomfort
|
|
|
Additional description: Limb discomfort
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Pain in extremity
|
|
|
Additional description: Pain in extremity
|
|
|
subjects affected / exposed
|
5 / 221 (2.26%) |
1 / 111 (0.90%) |
occurrences all number
|
5 |
1 |
Chest wall mass
|
|
|
Additional description: Chest wall mass
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Joint stiffness
|
|
|
Additional description: Joint stiffness
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
1 / 111 (0.90%) |
occurrences all number
|
1 |
1 |
Muscle spasms
|
|
|
Additional description: Muscle spasms
|
|
|
subjects affected / exposed
|
3 / 221 (1.36%) |
3 / 111 (2.70%) |
occurrences all number
|
3 |
3 |
Arthralgia
|
|
|
Additional description: Arthralgia
|
|
|
subjects affected / exposed
|
31 / 221 (14.03%) |
18 / 111 (16.22%) |
occurrences all number
|
38 |
21 |
Arthritis
|
|
|
Additional description: Arthritis
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
1 / 111 (0.90%) |
occurrences all number
|
2 |
1 |
Muscular weakness
|
|
|
Additional description: Muscular weakness
|
|
|
subjects affected / exposed
|
5 / 221 (2.26%) |
1 / 111 (0.90%) |
occurrences all number
|
5 |
1 |
Tendonitis
|
|
|
Additional description: Tendonitis
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
1 / 111 (0.90%) |
occurrences all number
|
1 |
1 |
Arthropathy
|
|
|
Additional description: Arthropathy
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
2 |
0 |
Joint swelling
|
|
|
Additional description: Joint swelling
|
|
|
subjects affected / exposed
|
3 / 221 (1.36%) |
1 / 111 (0.90%) |
occurrences all number
|
3 |
1 |
Groin pain
|
|
|
Additional description: Groin pain
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
0 / 111 (0.00%) |
occurrences all number
|
2 |
0 |
Back pain
|
|
|
Additional description: Back pain
|
|
|
subjects affected / exposed
|
16 / 221 (7.24%) |
9 / 111 (8.11%) |
occurrences all number
|
16 |
10 |
Infections and infestations
|
|
|
Skin infection
|
|
|
Additional description: Skin infection
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
0 / 111 (0.00%) |
occurrences all number
|
2 |
0 |
COVID-19
|
|
|
Additional description: COVID-19
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Tooth infection
|
|
|
Additional description: Tooth infection
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Oral candidiasis
|
|
|
Additional description: Oral candidiasis
|
|
|
subjects affected / exposed
|
10 / 221 (4.52%) |
7 / 111 (6.31%) |
occurrences all number
|
10 |
8 |
Staphylococcal infection
|
|
|
Additional description: Staphylococcal infection
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Gastroenteritis viral
|
|
|
Additional description: Gastroenteritis viral
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Spontaneous bacterial peritonitis
|
|
|
Additional description: Spontaneous bacterial peritonitis
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Conjunctivitis
|
|
|
Additional description: Conjunctivitis
|
|
|
subjects affected / exposed
|
3 / 221 (1.36%) |
2 / 111 (1.80%) |
occurrences all number
|
5 |
2 |
Sinusitis
|
|
|
Additional description: Sinusitis
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
1 / 111 (0.90%) |
occurrences all number
|
1 |
1 |
Nasopharyngitis
|
|
|
Additional description: Nasopharyngitis
|
|
|
subjects affected / exposed
|
4 / 221 (1.81%) |
2 / 111 (1.80%) |
occurrences all number
|
4 |
2 |
Wound infection
|
|
|
Additional description: Wound infection
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
2 |
0 |
Laryngitis
|
|
|
Additional description: Laryngitis
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Infection
|
|
|
Additional description: Infection
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Gastroenteritis
|
|
|
Additional description: Gastroenteritis
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Influenza
|
|
|
Additional description: Influenza
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
0 / 111 (0.00%) |
occurrences all number
|
2 |
0 |
Viral infection
|
|
|
Additional description: Viral infection
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
2 / 111 (1.80%) |
occurrences all number
|
2 |
2 |
Candida infection
|
|
|
Additional description: Candida infection
|
|
|
subjects affected / exposed
|
6 / 221 (2.71%) |
1 / 111 (0.90%) |
occurrences all number
|
6 |
1 |
Rash pustular
|
|
|
Additional description: Rash pustular
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Ear infection
|
|
|
Additional description: Ear infection
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Lower respiratory tract infection
|
|
|
Additional description: Lower respiratory tract infection
|
|
|
subjects affected / exposed
|
37 / 221 (16.74%) |
12 / 111 (10.81%) |
occurrences all number
|
45 |
14 |
Lymphangitis
|
|
|
Additional description: Lymphangitis
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Cellulitis
|
|
|
Additional description: Cellulitis
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Mucosal infection
|
|
|
Additional description: Mucosal infection
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
0 / 111 (0.00%) |
occurrences all number
|
2 |
0 |
Cystitis
|
|
|
Additional description: Cystitis
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
0 / 111 (0.00%) |
occurrences all number
|
2 |
0 |
Pneumonia
|
|
|
Additional description: Pneumonia
|
|
|
subjects affected / exposed
|
7 / 221 (3.17%) |
5 / 111 (4.50%) |
occurrences all number
|
7 |
5 |
Upper respiratory tract infection
|
|
|
Additional description: Upper respiratory tract infection
|
|
|
subjects affected / exposed
|
8 / 221 (3.62%) |
5 / 111 (4.50%) |
occurrences all number
|
8 |
5 |
Urinary tract infection
|
|
|
Additional description: Urinary tract infection
|
|
|
subjects affected / exposed
|
10 / 221 (4.52%) |
4 / 111 (3.60%) |
occurrences all number
|
14 |
5 |
Vulvovaginal candidiasis
|
|
|
Additional description: Vulvovaginal candidiasis
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Eye infection
|
|
|
Additional description: Eye infection
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Gingivitis
|
|
|
Additional description: Gingivitis
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Oral herpes
|
|
|
Additional description: Oral herpes
|
|
|
subjects affected / exposed
|
4 / 221 (1.81%) |
1 / 111 (0.90%) |
occurrences all number
|
4 |
1 |
Paronychia
|
|
|
Additional description: Paronychia
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Tinea pedis
|
|
|
Additional description: Tinea pedis
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Herpes zoster
|
|
|
Additional description: Herpes zoster
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Medical device site infection
|
|
|
Additional description: Medical device site infection
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Oesophageal candidiasis
|
|
|
Additional description: Oesophageal candidiasis
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Metabolism and nutrition disorders
|
|
|
Hypophosphataemia
|
|
|
Additional description: Hypophosphataemia
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
2 / 111 (1.80%) |
occurrences all number
|
0 |
2 |
Hypophagia
|
|
|
Additional description: Hypophagia
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Decreased appetite
|
|
|
Additional description: Decreased appetite
|
|
|
subjects affected / exposed
|
44 / 221 (19.91%) |
26 / 111 (23.42%) |
occurrences all number
|
45 |
29 |
Hyperglycaemia
|
|
|
Additional description: Hyperglycaemia
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Dehydration
|
|
|
Additional description: Dehydration
|
|
|
subjects affected / exposed
|
3 / 221 (1.36%) |
2 / 111 (1.80%) |
occurrences all number
|
3 |
2 |
Hypoalbuminaemia
|
|
|
Additional description: Hypoalbuminaemia
|
|
|
subjects affected / exposed
|
3 / 221 (1.36%) |
0 / 111 (0.00%) |
occurrences all number
|
3 |
0 |
Hypoglycaemia
|
|
|
Additional description: Hypoglycaemia
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Polydipsia
|
|
|
Additional description: Polydipsia
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
1 |
Vitamin D deficiency
|
|
|
Additional description: Vitamin D deficiency
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Hyponatraemia
|
|
|
Additional description: Hyponatraemia
|
|
|
subjects affected / exposed
|
2 / 221 (0.90%) |
2 / 111 (1.80%) |
occurrences all number
|
3 |
2 |
Hypokalaemia
|
|
|
Additional description: Hypokalaemia
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Gout
|
|
|
Additional description: Gout
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Hyperamylasaemia
|
|
|
Additional description: Hyperamylasaemia
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |
Hypercalcaemia
|
|
|
Additional description: Hypercalcaemia
|
|
|
subjects affected / exposed
|
0 / 221 (0.00%) |
1 / 111 (0.90%) |
occurrences all number
|
0 |
2 |
Hyperkalaemia
|
|
|
Additional description: Hyperkalaemia
|
|
|
subjects affected / exposed
|
3 / 221 (1.36%) |
0 / 111 (0.00%) |
occurrences all number
|
4 |
0 |
Hypomagnesaemia
|
|
|
Additional description: Hypomagnesaemia
|
|
|
subjects affected / exposed
|
1 / 221 (0.45%) |
0 / 111 (0.00%) |
occurrences all number
|
1 |
0 |