Non-serious adverse events
|
Alglucosidase Alfa 4000 L |
Total subjects affected by non serious adverse events
|
|
subjects affected / exposed
|
113 / 113 (100.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
Cholesteatoma
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Vascular disorders
|
|
Aortic Dilatation
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Flushing
|
|
subjects affected / exposed
|
7 / 113 (6.19%) |
occurrences all number
|
13 |
Hypertension
|
|
subjects affected / exposed
|
5 / 113 (4.42%) |
occurrences all number
|
5 |
Haematoma
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
3 |
Pallor
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Hypotension
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Peripheral Coldness
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Surgical and medical procedures
|
|
Central Venous Catheterisation
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
2 |
Ear Tube Removal
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Gastrostomy Tube Removal
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
2 |
General disorders and administration site conditions
|
|
Abasia
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Asthenia
|
|
subjects affected / exposed
|
4 / 113 (3.54%) |
occurrences all number
|
4 |
Catheter Site Erythema
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Catheter Site Haemorrhage
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Catheter Site Extravasation
|
|
subjects affected / exposed
|
4 / 113 (3.54%) |
occurrences all number
|
5 |
Catheter Site Inflammation
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Catheter Site Oedema
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Catheter Site Pain
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
3 |
Catheter Site Rash
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Catheter Site Related Reaction
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Catheter Site Swelling
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Chest Discomfort
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
3 |
Chills
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Chest Pain
|
|
subjects affected / exposed
|
6 / 113 (5.31%) |
occurrences all number
|
8 |
Crepitations
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Device Breakage
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Device Dislocation
|
|
subjects affected / exposed
|
4 / 113 (3.54%) |
occurrences all number
|
6 |
Device Issue
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Device Malfunction
|
|
subjects affected / exposed
|
9 / 113 (7.96%) |
occurrences all number
|
21 |
Device Occlusion
|
|
subjects affected / exposed
|
13 / 113 (11.50%) |
occurrences all number
|
15 |
Discomfort
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Disease Progression
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Energy Increased
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Extravasation
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Fatigue
|
|
subjects affected / exposed
|
4 / 113 (3.54%) |
occurrences all number
|
4 |
Feeling Hot
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Gait Disturbance
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Granuloma
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
5 |
Gravitational Oedema
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Influenza Like Illness
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Infusion Site Extravasation
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Infusion Site Swelling
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Injection Site Extravasation
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Injection Site Swelling
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Oedema
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
3 |
Malaise
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Oedema Peripheral
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Pain
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
3 |
Peripheral Swelling
|
|
subjects affected / exposed
|
4 / 113 (3.54%) |
occurrences all number
|
5 |
Pyrexia
|
|
subjects affected / exposed
|
61 / 113 (53.98%) |
occurrences all number
|
218 |
Secretion Discharge
|
|
subjects affected / exposed
|
6 / 113 (5.31%) |
occurrences all number
|
9 |
Thirst
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Thrombosis In Device
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Immune system disorders
|
|
Food Allergy
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Drug Hypersensitivity
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Hypersensitivity
|
|
subjects affected / exposed
|
5 / 113 (4.42%) |
occurrences all number
|
5 |
Multiple Allergies
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Seasonal Allergy
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Reproductive system and breast disorders
|
|
Genital Discomfort
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Vaginal Prolapse
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Vulvovaginal Disorder
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Vulvovaginal Erythema
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Vulvovaginal Pruritus
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Respiratory, thoracic and mediastinal disorders
|
|
Adenoidal Hypertrophy
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Aspiration
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
3 |
Atelectasis
|
|
subjects affected / exposed
|
5 / 113 (4.42%) |
occurrences all number
|
6 |
Bronchial Hyperreactivity
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
4 |
Bronchial Secretion Retention
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
6 |
Bronchial Wall Thickening
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Bronchomalacia
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Bronchospasm
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Choking
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
5 |
Cough
|
|
subjects affected / exposed
|
36 / 113 (31.86%) |
occurrences all number
|
105 |
Dysphonia
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Dyspnoea
|
|
subjects affected / exposed
|
6 / 113 (5.31%) |
occurrences all number
|
11 |
Epistaxis
|
|
subjects affected / exposed
|
5 / 113 (4.42%) |
occurrences all number
|
5 |
Haemoptysis
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
5 |
Hypercapnia
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Hypoventilation
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Hypoxia
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Increased Bronchial Secretion
|
|
subjects affected / exposed
|
5 / 113 (4.42%) |
occurrences all number
|
5 |
Increased Upper Airway Secretion
|
|
subjects affected / exposed
|
7 / 113 (6.19%) |
occurrences all number
|
11 |
Increased Viscosity Of Bronchial Secretion
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
3 |
Nasal Congestion
|
|
subjects affected / exposed
|
16 / 113 (14.16%) |
occurrences all number
|
23 |
Nasal Discharge Discolouration
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Nasal Dryness
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Oropharyngeal Pain
|
|
subjects affected / exposed
|
13 / 113 (11.50%) |
occurrences all number
|
14 |
Pleural Effusion
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Pneumonia Aspiration
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
4 |
Productive Cough
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
3 |
Pulmonary Artery Dilatation
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Pulmonary Congestion
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Respiratory Disorder
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Pulmonary Hypertension
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Respiratory Distress
|
|
subjects affected / exposed
|
8 / 113 (7.08%) |
occurrences all number
|
10 |
Respiratory Failure
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Respiratory Muscle Weakness
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
3 |
Respiratory Tract Congestion
|
|
subjects affected / exposed
|
7 / 113 (6.19%) |
occurrences all number
|
8 |
Respiratory Tract Haemorrhage
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
4 |
Rhinitis Allergic
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Rhinorrhoea
|
|
subjects affected / exposed
|
24 / 113 (21.24%) |
occurrences all number
|
42 |
Rhonchi
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Sleep Apnoea Syndrome
|
|
subjects affected / exposed
|
4 / 113 (3.54%) |
occurrences all number
|
4 |
Sinus Congestion
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
3 |
Sneezing
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Snoring
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Sputum Discoloured
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Sputum Increased
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
2 |
Tachypnoea
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Throat Irritation
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
3 |
Throat Tightness
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
3 |
Tonsillar Hypertrophy
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Tracheal Ulcer
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Upper Respiratory Tract Congestion
|
|
subjects affected / exposed
|
8 / 113 (7.08%) |
occurrences all number
|
14 |
Upper-Airway Cough Syndrome
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
2 |
Use Of Accessory Respiratory Muscles
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
2 |
Wheezing
|
|
subjects affected / exposed
|
5 / 113 (4.42%) |
occurrences all number
|
6 |
Psychiatric disorders
|
|
Aggression
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
2 |
Agitation
|
|
subjects affected / exposed
|
4 / 113 (3.54%) |
occurrences all number
|
7 |
Anxiety
|
|
subjects affected / exposed
|
5 / 113 (4.42%) |
occurrences all number
|
5 |
Bruxism
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Attention Deficit/Hyperactivity Disorder
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Insomnia
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
5 |
Irritability
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Mental Disorder
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Mood Swings
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Oppositional Defiant Disorder
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Sleep Disorder
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Investigations
|
|
Alanine Aminotransferase Abnormal
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Alanine Aminotransferase Increased
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
4 |
Aspartate Aminotransferase Abnormal
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Aspartate Aminotransferase Increased
|
|
subjects affected / exposed
|
4 / 113 (3.54%) |
occurrences all number
|
5 |
Atrial Pressure Increased
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Blood Alkaline Phosphatase Increased
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Blood Creatine Phosphokinase Abnormal
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Blood Creatine Phosphokinase Mb Increased
|
|
subjects affected / exposed
|
7 / 113 (6.19%) |
occurrences all number
|
7 |
Blood Culture Positive
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Blood Creatine Phosphokinase Increased
|
|
subjects affected / exposed
|
7 / 113 (6.19%) |
occurrences all number
|
7 |
Blood Lactate Dehydrogenase Abnormal
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Blood Lactate Dehydrogenase Increased
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Blood Potassium Decreased
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
3 |
Blood Pressure Decreased
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Blood Pressure Increased
|
|
subjects affected / exposed
|
7 / 113 (6.19%) |
occurrences all number
|
8 |
Blood Pressure Systolic Increased
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Blood Uric Acid Decreased
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Blood Uric Acid Increased
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Blood Zinc Decreased
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Body Temperature Increased
|
|
subjects affected / exposed
|
5 / 113 (4.42%) |
occurrences all number
|
5 |
Brain Natriuretic Peptide Increased
|
|
subjects affected / exposed
|
5 / 113 (4.42%) |
occurrences all number
|
5 |
Breath Sounds Abnormal
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Creatine Urine Increased
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Creatinine Urine Increased
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Electrocardiogram Pr Shortened
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Electrocardiogram St Segment Elevation
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Electrocardiogram Qt Prolonged
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Eosinophil Count Increased
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Electrocardiogram Abnormal
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Gamma-Glutamyltransferase Increased
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Haematocrit Decreased
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Haemoglobin Decreased
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
4 |
Heart Rate Increased
|
|
subjects affected / exposed
|
5 / 113 (4.42%) |
occurrences all number
|
5 |
Liver Function Test Abnormal
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Neutrophil Count Increased
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Neutrophil Count Abnormal
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Occult Blood Positive
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Neutrophil Percentage Increased
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Oxygen Saturation Decreased
|
|
subjects affected / exposed
|
4 / 113 (3.54%) |
occurrences all number
|
6 |
Platelet Count Increased
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Protein Urine
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Protein Urine Present
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Pulmonary Function Test Decreased
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Pulse Pressure Abnormal
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Respiratory Rate Increased
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Specific Gravity Urine
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Serum Ferritin Decreased
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Sputum Culture Positive
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Staphylococcus Test Positive
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Urine Ketone Body Present
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Tuberculin Test Positive
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Urine Output Decreased
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Weight Decreased
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Weight Increased
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
3 |
White Blood Cell Count Abnormal
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
White Blood Cell Count Increased
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Injury, poisoning and procedural complications
|
|
Agitation Postoperative
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Animal Bite
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Ankle Fracture
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Animal Scratch
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Arthropod Bite
|
|
subjects affected / exposed
|
7 / 113 (6.19%) |
occurrences all number
|
8 |
Arthropod Sting
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Concussion
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Contusion
|
|
subjects affected / exposed
|
6 / 113 (5.31%) |
occurrences all number
|
7 |
Exposure To Communicable Disease
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Eye Contusion
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Eye Injury
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Face Injury
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Fall
|
|
subjects affected / exposed
|
11 / 113 (9.73%) |
occurrences all number
|
13 |
Feeding Tube Complication
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Femur Fracture
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Gastrointestinal Anastomotic Leak
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
3 |
Foreign Body
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Gastrointestinal Stoma Complication
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Hand Fracture
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Head Injury
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
3 |
Joint Dislocation
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Humerus Fracture
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Laryngeal Injury
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Laceration
|
|
subjects affected / exposed
|
6 / 113 (5.31%) |
occurrences all number
|
6 |
Ligament Sprain
|
|
subjects affected / exposed
|
5 / 113 (4.42%) |
occurrences all number
|
5 |
Limb Injury
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Lower Limb Fracture
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Overdose
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Periorbital Haemorrhage
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Post Procedural Haemorrhage
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Postoperative Respiratory Distress
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Postoperative Fever
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Procedural Nausea
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Procedural Pain
|
|
subjects affected / exposed
|
8 / 113 (7.08%) |
occurrences all number
|
10 |
Procedural Vomiting
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Scratch
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Skin Wound
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Skin Abrasion
|
|
subjects affected / exposed
|
9 / 113 (7.96%) |
occurrences all number
|
14 |
Soft Tissue Injury
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Splinter
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
2 |
Stoma Site Erythema
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Stoma Site Irritation
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
3 |
Stoma Site Haemorrhage
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Stoma Site Reaction
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Stoma Site Rash
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Thermal Burn
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Sunburn
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Tooth Avulsion
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Tibia Fracture
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Tooth Fracture
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Tooth Injury
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Tracheostomy Malfunction
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Vaccination Complication
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Wound
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Wound Dehiscence
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Congenital, familial and genetic disorders
|
|
Cryptorchism
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Cardiac disorders
|
|
Arrhythmia
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
3 |
Bundle Branch Block Right
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Bradycardia
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
4 |
Cardiac Failure
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Cardiomyopathy
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Diastolic Dysfunction
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Defect Conduction Intraventricular
|
|
subjects affected / exposed
|
4 / 113 (3.54%) |
occurrences all number
|
4 |
Heart Valve Incompetence
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Left Ventricular Dysfunction
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Pericardial Effusion
|
|
subjects affected / exposed
|
5 / 113 (4.42%) |
occurrences all number
|
6 |
Right Atrial Dilatation
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Right Ventricular Hypertrophy
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Sinus Tachycardia
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
3 |
Sinus Bradycardia
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
2 |
Tachycardia
|
|
subjects affected / exposed
|
13 / 113 (11.50%) |
occurrences all number
|
21 |
Supraventricular Tachycardia
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
13 |
Wolff-Parkinson-White Syndrome
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Tricuspid Valve Incompetence
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Nervous system disorders
|
|
Allodynia
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Areflexia
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Burning Sensation
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Clumsiness
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Convulsion
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Dizziness
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
3 |
Facial Paresis
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Formication
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Gross Motor Delay
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Headache
|
|
subjects affected / exposed
|
14 / 113 (12.39%) |
occurrences all number
|
36 |
Hypoaesthesia
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
2 |
Hyporeflexia
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Hypotonia
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Lethargy
|
|
subjects affected / exposed
|
4 / 113 (3.54%) |
occurrences all number
|
8 |
Motor Developmental Delay
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Motor Dysfunction
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Muscle Contractions Involuntary
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Nystagmus
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Paraesthesia
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Paralysis Flaccid
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Poor Quality Sleep
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Presyncope
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Psychomotor Hyperactivity
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
2 |
Somnolence
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Speech Disorder
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Tremor
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Blood and lymphatic system disorders
|
|
Anaemia
|
|
subjects affected / exposed
|
7 / 113 (6.19%) |
occurrences all number
|
8 |
Coagulopathy
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Eosinophilia
|
|
subjects affected / exposed
|
6 / 113 (5.31%) |
occurrences all number
|
7 |
Iron Deficiency Anaemia
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Lymphadenitis
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Lymphadenopathy
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Neutropenia
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Ear and labyrinth disorders
|
|
Cerumen Impaction
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
5 |
Conductive Deafness
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Deafness
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Deafness Neurosensory
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Deafness Unilateral
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Ear Pain
|
|
subjects affected / exposed
|
5 / 113 (4.42%) |
occurrences all number
|
8 |
Eustachian Tube Dysfunction
|
|
subjects affected / exposed
|
5 / 113 (4.42%) |
occurrences all number
|
5 |
Middle Ear Effusion
|
|
subjects affected / exposed
|
5 / 113 (4.42%) |
occurrences all number
|
5 |
Otorrhoea
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
3 |
Mixed Deafness
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Tympanic Membrane Disorder
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Tympanic Membrane Perforation
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Eye disorders
|
|
Blepharitis
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Astigmatism
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Chalazion
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Conjunctival Hyperaemia
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Eye Discharge
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
2 |
Dry Eye
|
|
subjects affected / exposed
|
4 / 113 (3.54%) |
occurrences all number
|
5 |
Eye Pruritus
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Eye Irritation
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Eye Swelling
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Eyelid Ptosis
|
|
subjects affected / exposed
|
4 / 113 (3.54%) |
occurrences all number
|
6 |
Eyelid Oedema
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Hypermetropia
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Lid Sulcus Deepened
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Ocular Hyperaemia
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Myopia
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Photophobia
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Strabismus
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Vision Blurred
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Gastrointestinal disorders
|
|
Abdominal Discomfort
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
3 |
Abdominal Distension
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Abdominal Pain
|
|
subjects affected / exposed
|
10 / 113 (8.85%) |
occurrences all number
|
17 |
Abnormal Faeces
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Abdominal Pain Upper
|
|
subjects affected / exposed
|
11 / 113 (9.73%) |
occurrences all number
|
18 |
Anal Fissure
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Aphthous Stomatitis
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
2 |
Constipation
|
|
subjects affected / exposed
|
20 / 113 (17.70%) |
occurrences all number
|
23 |
Dental Caries
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
3 |
Dental Discomfort
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Dysphagia
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Diarrhoea
|
|
subjects affected / exposed
|
55 / 113 (48.67%) |
occurrences all number
|
121 |
Faecal Incontinence
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Faeces Discoloured
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Flatulence
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
2 |
Gastric Ulcer
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Frequent Bowel Movements
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
3 |
Gastrointestinal Disorder
|
|
subjects affected / exposed
|
4 / 113 (3.54%) |
occurrences all number
|
10 |
Gastritis
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Gastrooesophageal Reflux Disease
|
|
subjects affected / exposed
|
4 / 113 (3.54%) |
occurrences all number
|
4 |
Gingival Bleeding
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Haematochezia
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Haemorrhoids
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Ileus
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Lip Blister
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Infrequent Bowel Movements
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Mouth Ulceration
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Lip Ulceration
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Nausea
|
|
subjects affected / exposed
|
12 / 113 (10.62%) |
occurrences all number
|
20 |
Oral Disorder
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Rectal Fissure
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Regurgitation
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Retained Deciduous Tooth
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Retching
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Salivary Hypersecretion
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Sensitivity Of Teeth
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Teething
|
|
subjects affected / exposed
|
4 / 113 (3.54%) |
occurrences all number
|
4 |
Tongue Spasm
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Tooth Deposit
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Toothache
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Tooth Impacted
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Vomiting
|
|
subjects affected / exposed
|
42 / 113 (37.17%) |
occurrences all number
|
112 |
Hepatobiliary disorders
|
|
Hepatic Fibrosis
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Cholelithiasis
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
2 |
Skin and subcutaneous tissue disorders
|
|
Acne
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
3 |
Alopecia
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
3 |
Blister
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Cold Sweat
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Decubitus Ulcer
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
3 |
Dermatitis
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
3 |
Dermatitis Allergic
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Dermatitis Diaper
|
|
subjects affected / exposed
|
4 / 113 (3.54%) |
occurrences all number
|
6 |
Dermatitis Contact
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
3 |
Dry Skin
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Ecchymosis
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Eczema
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Erythema
|
|
subjects affected / exposed
|
5 / 113 (4.42%) |
occurrences all number
|
9 |
Excessive Granulation Tissue
|
|
subjects affected / exposed
|
4 / 113 (3.54%) |
occurrences all number
|
5 |
Granuloma Skin
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Hyperhidrosis
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
2 |
Hyperkeratosis
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
2 |
Ingrowing Nail
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Ingrown Hair
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Macule
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Mechanical Urticaria
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Papule
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
3 |
Petechiae
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Photosensitivity Reaction
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Pruritus
|
|
subjects affected / exposed
|
5 / 113 (4.42%) |
occurrences all number
|
6 |
Pruritus Generalised
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
2 |
Rash
|
|
subjects affected / exposed
|
31 / 113 (27.43%) |
occurrences all number
|
42 |
Rash Erythematous
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Rash Macular
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
2 |
Rash Pruritic
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Red Man Syndrome
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Skin Disorder
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Seborrhoeic Dermatitis
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Skin Exfoliation
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Skin Hyperpigmentation
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Skin Irritation
|
|
subjects affected / exposed
|
4 / 113 (3.54%) |
occurrences all number
|
4 |
Skin Lesion
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Skin Ulcer
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Swelling Face
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Urticaria
|
|
subjects affected / exposed
|
9 / 113 (7.96%) |
occurrences all number
|
28 |
Renal and urinary disorders
|
|
Dysuria
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
3 |
Haematuria
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Incontinence
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Nephrolithiasis
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
2 |
Pollakiuria
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Proteinuria
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Urinary Hesitation
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Urinary Incontinence
|
|
subjects affected / exposed
|
4 / 113 (3.54%) |
occurrences all number
|
4 |
Urinary Retention
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
2 |
Endocrine disorders
|
|
Precocious Puberty
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Musculoskeletal and connective tissue disorders
|
|
Arthralgia
|
|
subjects affected / exposed
|
5 / 113 (4.42%) |
occurrences all number
|
7 |
Arthropathy
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Back Pain
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
6 |
Axillary Mass
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Foot Deformity
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Deformity Thorax
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Fracture Pain
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Hip Deformity
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Joint Contracture
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
3 |
Joint Stiffness
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Joint Swelling
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
3 |
Kyphosis
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Limb Discomfort
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Muscle Contracture
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Muscle Spasms
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
3 |
Muscle Tightness
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Muscular Weakness
|
|
subjects affected / exposed
|
12 / 113 (10.62%) |
occurrences all number
|
15 |
Musculoskeletal Pain
|
|
subjects affected / exposed
|
4 / 113 (3.54%) |
occurrences all number
|
5 |
Musculoskeletal Chest Pain
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Musculoskeletal Stiffness
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Myalgia
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Myopathy
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Neck Pain
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
5 |
Osteopenia
|
|
subjects affected / exposed
|
4 / 113 (3.54%) |
occurrences all number
|
4 |
Pain In Jaw
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
3 |
Pain In Extremity
|
|
subjects affected / exposed
|
16 / 113 (14.16%) |
occurrences all number
|
23 |
Scoliosis
|
|
subjects affected / exposed
|
6 / 113 (5.31%) |
occurrences all number
|
6 |
Tendinous Contracture
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Tendon Discomfort
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
3 |
Tendon Disorder
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Infections and infestations
|
|
Abscess Limb
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Acarodermatitis
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Adenovirus Infection
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Atypical Pneumonia
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Bacterial Tracheitis
|
|
subjects affected / exposed
|
5 / 113 (4.42%) |
occurrences all number
|
7 |
Beta Haemolytic Streptococcal Infection
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Body Tinea
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
3 |
Bronchiolitis
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Candida Infection
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Bronchitis
|
|
subjects affected / exposed
|
8 / 113 (7.08%) |
occurrences all number
|
8 |
Chronic Sinusitis
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
2 |
Cellulitis
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Clostridium Difficile Colitis
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
3 |
Conjunctivitis
|
|
subjects affected / exposed
|
7 / 113 (6.19%) |
occurrences all number
|
9 |
Croup Infectious
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Ear Infection
|
|
subjects affected / exposed
|
12 / 113 (10.62%) |
occurrences all number
|
20 |
Device Related Infection
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Enterovirus Infection
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Ear Lobe Infection
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Escherichia Urinary Tract Infection
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Erythema Infectiosum
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Folliculitis
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Eye Infection
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Fungal Infection
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Fungal Skin Infection
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Furuncle
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Gastroenteritis
|
|
subjects affected / exposed
|
11 / 113 (9.73%) |
occurrences all number
|
15 |
Gastroenteritis Viral
|
|
subjects affected / exposed
|
4 / 113 (3.54%) |
occurrences all number
|
4 |
Gastroenteritis Norovirus
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Gastrointestinal Infection
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
2 |
Gingival Abscess
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Gingivitis
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Haemophilus Infection
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Hand-Foot-And-Mouth Disease
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Herpes Zoster
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Hordeolum
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
5 |
Impetigo
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Infection
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Influenza
|
|
subjects affected / exposed
|
8 / 113 (7.08%) |
occurrences all number
|
10 |
Labyrinthitis
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Lice Infestation
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Lobar Pneumonia
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Lip Infection
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
2 |
Nail Infection
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Nasopharyngitis
|
|
subjects affected / exposed
|
12 / 113 (10.62%) |
occurrences all number
|
23 |
Oral Candidiasis
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
4 |
Oral Herpes
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Otitis Externa Fungal
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Otitis Externa
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
5 |
Otitis Media
|
|
subjects affected / exposed
|
23 / 113 (20.35%) |
occurrences all number
|
35 |
Otitis Media Acute
|
|
subjects affected / exposed
|
6 / 113 (5.31%) |
occurrences all number
|
7 |
Otitis Media Chronic
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
6 |
Pharyngitis
|
|
subjects affected / exposed
|
7 / 113 (6.19%) |
occurrences all number
|
14 |
Pharyngitis Streptococcal
|
|
subjects affected / exposed
|
13 / 113 (11.50%) |
occurrences all number
|
24 |
Pneumonia
|
|
subjects affected / exposed
|
17 / 113 (15.04%) |
occurrences all number
|
32 |
Pneumonia Viral
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Pseudomonas Infection
|
|
subjects affected / exposed
|
4 / 113 (3.54%) |
occurrences all number
|
5 |
Rash Pustular
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
2 |
Respiratory Tract Infection
|
|
subjects affected / exposed
|
5 / 113 (4.42%) |
occurrences all number
|
5 |
Respiratory Syncytial Virus Infection
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
3 |
Rhinitis
|
|
subjects affected / exposed
|
6 / 113 (5.31%) |
occurrences all number
|
8 |
Rhinovirus Infection
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
4 |
Rotavirus Infection
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Sinusitis
|
|
subjects affected / exposed
|
5 / 113 (4.42%) |
occurrences all number
|
6 |
Skin Infection
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
2 |
Staphylococcal Infection
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
5 |
Stoma Site Infection
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Streptococcal Infection
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
3 |
Streptococcal Urinary Tract Infection
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Subcutaneous Abscess
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
2 |
Tinea Infection
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Tooth Abscess
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
3 |
Tonsillitis
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Tracheitis
|
|
subjects affected / exposed
|
7 / 113 (6.19%) |
occurrences all number
|
12 |
Tooth Infection
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Tracheobronchitis
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Tracheostomy Infection
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
9 |
Upper Respiratory Tract Infection Bacterial
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
2 |
Upper Respiratory Tract Infection
|
|
subjects affected / exposed
|
49 / 113 (43.36%) |
occurrences all number
|
104 |
Urinary Tract Infection
|
|
subjects affected / exposed
|
19 / 113 (16.81%) |
occurrences all number
|
31 |
Viral Infection
|
|
subjects affected / exposed
|
15 / 113 (13.27%) |
occurrences all number
|
23 |
Viral Rash
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Viral Upper Respiratory Tract Infection
|
|
subjects affected / exposed
|
5 / 113 (4.42%) |
occurrences all number
|
7 |
Vulvovaginal Mycotic Infection
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Metabolism and nutrition disorders
|
|
Abnormal Weight Gain
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Decreased Appetite
|
|
subjects affected / exposed
|
4 / 113 (3.54%) |
occurrences all number
|
4 |
Dehydration
|
|
subjects affected / exposed
|
5 / 113 (4.42%) |
occurrences all number
|
7 |
Electrolyte Imbalance
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Failure To Thrive
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Hypochloraemia
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Hypoalbuminaemia
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Hypoglycaemia
|
|
subjects affected / exposed
|
3 / 113 (2.65%) |
occurrences all number
|
3 |
Iron Deficiency
|
|
subjects affected / exposed
|
1 / 113 (0.88%) |
occurrences all number
|
1 |
Hypokalaemia
|
|
subjects affected / exposed
|
2 / 113 (1.77%) |
occurrences all number
|
2 |
Vitamin D Deficiency
|
|
subjects affected / exposed
|
4 / 113 (3.54%) |
occurrences all number
|
4 |