Non-serious adverse events
|
FL patient |
RR patient |
Total subjects affected by non serious adverse events
|
|
|
subjects affected / exposed
|
40 / 40 (100.00%) |
26 / 26 (100.00%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Haemangioma of liver
|
|
|
Additional description: Haemangioma of liver
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Seborrhoeic keratosis
|
|
|
Additional description: Seborrhoeic keratosis
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
2 / 26 (7.69%) |
occurrences all number
|
0 |
2 |
Vascular disorders
|
|
|
Circulatory collapse
|
|
|
Additional description: Circulatory collapse
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Flushing
|
|
|
Additional description: Flushing
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Haematoma
|
|
|
Additional description: Haematoma
|
|
|
subjects affected / exposed
|
3 / 40 (7.50%) |
6 / 26 (23.08%) |
occurrences all number
|
4 |
7 |
Hypertension
|
|
|
Additional description: Hypertension
|
|
|
subjects affected / exposed
|
9 / 40 (22.50%) |
1 / 26 (3.85%) |
occurrences all number
|
9 |
1 |
Hypertensive crisis
|
|
|
Additional description: Hypertensive crisis
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Hypotension
|
|
|
Additional description: Hypotension
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
1 / 26 (3.85%) |
occurrences all number
|
1 |
1 |
Raynaud's phenomenon
|
|
|
Additional description: Raynaud's phenomenon
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Thrombophlebitis
|
|
|
Additional description: Thrombophlebitis
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
0 / 26 (0.00%) |
occurrences all number
|
2 |
0 |
Vascular calcification
|
|
|
Additional description: Vascular calcification
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Vasculitis
|
|
|
Additional description: Vasculitis
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Surgical and medical procedures
|
|
|
Cataract operation
|
|
|
Additional description: Cataract operation
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
2 |
Dental implantation
|
|
|
Additional description: Dental implantation
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Phlebectomy
|
|
|
Additional description: Phlebectomy
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Tooth extraction
|
|
|
Additional description: Tooth extraction
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
2 |
General disorders and administration site conditions
|
|
|
Chest discomfort
|
|
|
Additional description: Chest discomfort
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Chest pain
|
|
|
Additional description: Chest pain
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
0 / 26 (0.00%) |
occurrences all number
|
2 |
0 |
Chills
|
|
|
Additional description: Chills
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
2 / 26 (7.69%) |
occurrences all number
|
2 |
2 |
Extravasation
|
|
|
Additional description: Extravasation
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Fatigue
|
|
|
Additional description: Fatigue
|
|
|
subjects affected / exposed
|
16 / 40 (40.00%) |
10 / 26 (38.46%) |
occurrences all number
|
18 |
12 |
Gait disturbance
|
|
|
Additional description: Gait disturbance
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
0 / 26 (0.00%) |
occurrences all number
|
2 |
0 |
General physical health deterioration
|
|
|
Additional description: General physical health deterioration
|
|
|
subjects affected / exposed
|
3 / 40 (7.50%) |
0 / 26 (0.00%) |
occurrences all number
|
3 |
0 |
Impaired healing
|
|
|
Additional description: Impaired healing
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Injection site phlebitis
|
|
|
Additional description: Injection site phlebitis
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Mucosal inflammation
|
|
|
Additional description: Mucosal inflammation
|
|
|
subjects affected / exposed
|
4 / 40 (10.00%) |
1 / 26 (3.85%) |
occurrences all number
|
7 |
1 |
Oedema
|
|
|
Additional description: Oedema
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
0 / 26 (0.00%) |
occurrences all number
|
2 |
0 |
Oedema peripheral
|
|
|
Additional description: Oedema peripheral
|
|
|
subjects affected / exposed
|
5 / 40 (12.50%) |
7 / 26 (26.92%) |
occurrences all number
|
5 |
9 |
Pain
|
|
|
Additional description: Pain
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Peripheral swelling
|
|
|
Additional description: Peripheral swelling
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
1 / 26 (3.85%) |
occurrences all number
|
1 |
1 |
Pyrexia
|
|
|
Additional description: Pyrexia
|
|
|
subjects affected / exposed
|
3 / 40 (7.50%) |
1 / 26 (3.85%) |
occurrences all number
|
5 |
1 |
Soft tissue inflammation
|
|
|
Additional description: Soft tissue inflammation
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Immune system disorders
|
|
|
Drug hypersensitivity
|
|
|
Additional description: Drug hypersensitivity
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Hypersensitivity
|
|
|
Additional description: Hypersensitivity
|
|
|
subjects affected / exposed
|
3 / 40 (7.50%) |
1 / 26 (3.85%) |
occurrences all number
|
3 |
1 |
Hypogammaglobulinaemia
|
|
|
Additional description: Hypogammaglobulinaemia
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Immunodeficiency
|
|
|
Additional description: Immunodeficiency
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Immunodeficiency common variable
|
|
|
Additional description: Immunodeficiency common variable
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Social circumstances
|
|
|
Menopause
|
|
|
Additional description: Menopause
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Reproductive system and breast disorders
|
|
|
Benign prostatic hyperplasia
|
|
|
Additional description: Benign prostatic hyperplasia
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
1 / 26 (3.85%) |
occurrences all number
|
1 |
1 |
Menorrhagia
|
|
|
Additional description: Menorrhagia
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
0 / 26 (0.00%) |
occurrences all number
|
4 |
0 |
Prostatitis
|
|
|
Additional description: Prostatitis
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Uterine prolapse
|
|
|
Additional description: Uterine prolapse
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
Bronchial wall thickening
|
|
|
Additional description: Bronchial wall thickening
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Cough
|
|
|
Additional description: Cough
|
|
|
subjects affected / exposed
|
4 / 40 (10.00%) |
4 / 26 (15.38%) |
occurrences all number
|
6 |
4 |
Dyspnoea
|
|
|
Additional description: Dyspnoea
|
|
|
subjects affected / exposed
|
3 / 40 (7.50%) |
1 / 26 (3.85%) |
occurrences all number
|
3 |
1 |
Dyspnoea exertional
|
|
|
Additional description: Dyspnoea exertional
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
2 / 26 (7.69%) |
occurrences all number
|
1 |
2 |
Emphysema
|
|
|
Additional description: Emphysema
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Epistaxis
|
|
|
Additional description: Epistaxis
|
|
|
subjects affected / exposed
|
6 / 40 (15.00%) |
4 / 26 (15.38%) |
occurrences all number
|
8 |
4 |
Nasal dryness
|
|
|
Additional description: Nasal dryness
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
1 / 26 (3.85%) |
occurrences all number
|
1 |
1 |
Nasal mucosal disorder
|
|
|
Additional description: Nasal mucosal disorder
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Oropharyngeal pain
|
|
|
Additional description: Oropharyngeal pain
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Pleural effusion
|
|
|
Additional description: Pleural effusion
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Pneumonitis
|
|
|
Additional description: Pneumonitis
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
1 / 26 (3.85%) |
occurrences all number
|
2 |
1 |
Rhinorrhoea
|
|
|
Additional description: Rhinorrhoea
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Psychiatric disorders
|
|
|
Agitation
|
|
|
Additional description: Agitation
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Burnout syndrome
|
|
|
Additional description: Burnout syndrome
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Depression
|
|
|
Additional description: Depression
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
1 / 26 (3.85%) |
occurrences all number
|
2 |
1 |
Insomnia
|
|
|
Additional description: Insomnia
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
2 / 26 (7.69%) |
occurrences all number
|
3 |
2 |
Sleep disorder
|
|
|
Additional description: Sleep disorder
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
1 / 26 (3.85%) |
occurrences all number
|
1 |
1 |
Hepatobiliary disorders
|
|
|
Cholecystitis chronic
|
|
|
Additional description: Cholecystitis chronic
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Hepatic steatosis
|
|
|
Additional description: Hepatic steatosis
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
0 / 26 (0.00%) |
occurrences all number
|
2 |
0 |
Hepatotoxicity
|
|
|
Additional description: Hepatotoxicity
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Steatohepatitis
|
|
|
Additional description: Steatohepatitis
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
0 / 26 (0.00%) |
occurrences all number
|
2 |
0 |
Investigations
|
|
|
blood bilirubin increased
|
|
|
Additional description: blood bilirubin increased
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Blood creatinine increased
|
|
|
Additional description: Blood creatinine increased
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
1 / 26 (3.85%) |
occurrences all number
|
1 |
1 |
Borrelia test negative
|
|
|
Additional description: Borrelia test negative
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Endoscopy upper gastrointestinal tract
|
|
|
Additional description: Endoscopy upper gastrointestinal tract
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Eosinophil count increased
|
|
|
Additional description: Eosinophil count increased
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Gamma-glutamyltransferase increased
|
|
|
Additional description: Gamma-glutamyltransferase increased
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Haematocrit increased
|
|
|
Additional description: Haematocrit increased
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Hepatic enzyme increased
|
|
|
Additional description: Hepatic enzyme increased
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Laboratory test interference
|
|
|
Additional description: Laboratory test interference
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Prostatic specific antigen increased
|
|
|
Additional description: Prostatic specific antigen increased
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Weight decreased
|
|
|
Additional description: Weight decreased
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
2 / 26 (7.69%) |
occurrences all number
|
2 |
2 |
Weight increased
|
|
|
Additional description: Weight increased
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
0 / 26 (0.00%) |
occurrences all number
|
2 |
0 |
Injury, poisoning and procedural complications
|
|
|
Arthropod bite
|
|
|
Additional description: Arthropod bite
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Contusion
|
|
|
Additional description: Contusion
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
0 / 26 (0.00%) |
occurrences all number
|
2 |
0 |
Fracture
|
|
|
Additional description: Fracture
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Head injury
|
|
|
Additional description: Head injury
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Infusion related reaction
|
|
|
Additional description: Infusion related reaction
|
|
|
subjects affected / exposed
|
14 / 40 (35.00%) |
9 / 26 (34.62%) |
occurrences all number
|
30 |
14 |
Joint dislocation
|
|
|
Additional description: Joint dislocation
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Lumbar vertebral fracture
|
|
|
Additional description: Lumbar vertebral fracture
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
1 / 26 (3.85%) |
occurrences all number
|
1 |
1 |
Pneumonitis chemical
|
|
|
Additional description: Pneumonitis chemical
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Post procedural haematoma
|
|
|
Additional description: Post procedural haematoma
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Scratch
|
|
|
Additional description: Scratch
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Thermal burn
|
|
|
Additional description: Thermal burn
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Thoracic vertebral fracture
|
|
|
Additional description: Thoracic vertebral fracture
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
2 / 26 (7.69%) |
occurrences all number
|
0 |
2 |
Tooth fracture
|
|
|
Additional description: Tooth fracture
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Congenital, familial and genetic disorders
|
|
|
Gilbert's syndrome
|
|
|
Additional description: Gilbert's syndrome
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Cardiac disorders
|
|
|
Atrial fibrillation
|
|
|
Additional description: Atrial fibrillation
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
2 / 26 (7.69%) |
occurrences all number
|
1 |
2 |
Cardiovascular disorder
|
|
|
Additional description: Cardiovascular disorder
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Coronary artery disease
|
|
|
Additional description: Coronary artery disease
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Diastolic dysfunction
|
|
|
Additional description: Diastolic dysfunction
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Extrasystoles
|
|
|
Additional description: Extrasystoles
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Mitral valve incompetence
|
|
|
Additional description: Mitral valve incompetence
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Palpitations
|
|
|
Additional description: Palpitations
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
1 / 26 (3.85%) |
occurrences all number
|
3 |
1 |
Tricuspid valve incompetence
|
|
|
Additional description: Tricuspid valve incompetence
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Nervous system disorders
|
|
|
Burning sensation
|
|
|
Additional description: Burning sensation
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Carpal tunnel syndrome
|
|
|
Additional description: Carpal tunnel syndrome
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
1 / 26 (3.85%) |
occurrences all number
|
2 |
1 |
Cerebral amyloid angiopathy
|
|
|
Additional description: Cerebral amyloid angiopathy
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Cerebral atrophy
|
|
|
Additional description: Cerebral atrophy
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Cluster headache
|
|
|
Additional description: Cluster headache
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Dizziness
|
|
|
Additional description: Dizziness
|
|
|
subjects affected / exposed
|
4 / 40 (10.00%) |
2 / 26 (7.69%) |
occurrences all number
|
4 |
2 |
Encephalopathy
|
|
|
Additional description: Encephalopathy
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Headache
|
|
|
Additional description: Headache
|
|
|
subjects affected / exposed
|
7 / 40 (17.50%) |
2 / 26 (7.69%) |
occurrences all number
|
10 |
2 |
Hyperaesthesia
|
|
|
Additional description: Hyperaesthesia
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Hypoaesthesia
|
|
|
Additional description: Hypoaesthesia
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
1 / 26 (3.85%) |
occurrences all number
|
1 |
1 |
Hypotonia
|
|
|
Additional description: Hypotonia
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Memory impairment
|
|
|
Additional description: Memory impairment
|
|
|
subjects affected / exposed
|
3 / 40 (7.50%) |
0 / 26 (0.00%) |
occurrences all number
|
3 |
0 |
Mental impairment
|
|
|
Additional description: Mental impairment
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Muscle spasticity
|
|
|
Additional description: Muscle spasticity
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
0 / 26 (0.00%) |
occurrences all number
|
3 |
0 |
Nerve compression
|
|
|
Additional description: Nerve compression
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Nervous system disorder
|
|
|
Additional description: Nervous system disorder
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Paraesthesia
|
|
|
Additional description: Paraesthesia
|
|
|
subjects affected / exposed
|
4 / 40 (10.00%) |
1 / 26 (3.85%) |
occurrences all number
|
4 |
1 |
Peripheral sensory neuropathy
|
|
|
Additional description: Peripheral sensory neuropathy
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Polyneuropathy
|
|
|
Additional description: Polyneuropathy
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
1 / 26 (3.85%) |
occurrences all number
|
1 |
1 |
Sciatica
|
|
|
Additional description: Sciatica
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Syncope
|
|
|
Additional description: Syncope
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Tremor
|
|
|
Additional description: Tremor
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
3 / 26 (11.54%) |
occurrences all number
|
1 |
3 |
Blood and lymphatic system disorders
|
|
|
Anaemia
|
|
|
Additional description: Anaemia
|
|
|
subjects affected / exposed
|
3 / 40 (7.50%) |
4 / 26 (15.38%) |
occurrences all number
|
5 |
4 |
Leukopenia
|
|
|
Additional description: Leukopenia
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Lymph node pain
|
|
|
Additional description: Lymph node pain
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
2 / 26 (7.69%) |
occurrences all number
|
0 |
2 |
Neutropenia
|
|
|
Additional description: Neutropenia
|
|
|
subjects affected / exposed
|
16 / 40 (40.00%) |
9 / 26 (34.62%) |
occurrences all number
|
21 |
17 |
Perisplenitis
|
|
|
Additional description: Perisplenitis
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Thrombocytopenia
|
|
|
Additional description: Thrombocytopenia
|
|
|
subjects affected / exposed
|
4 / 40 (10.00%) |
4 / 26 (15.38%) |
occurrences all number
|
4 |
4 |
Ear and labyrinth disorders
|
|
|
Ear pain
|
|
|
Additional description: Ear pain
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Inner ear disorder
|
|
|
Additional description: Inner ear disorder
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
2 |
Tinnitus
|
|
|
Additional description: Tinnitus
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Vertigo
|
|
|
Additional description: Vertigo
|
|
|
subjects affected / exposed
|
5 / 40 (12.50%) |
4 / 26 (15.38%) |
occurrences all number
|
6 |
5 |
Eye disorders
|
|
|
Blepharitis
|
|
|
Additional description: Blepharitis
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Cataract
|
|
|
Additional description: Cataract
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
0 / 26 (0.00%) |
occurrences all number
|
2 |
0 |
Conjunctival haemorrhage
|
|
|
Additional description: Conjunctival haemorrhage
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Dry eye
|
|
|
Additional description: Dry eye
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
1 / 26 (3.85%) |
occurrences all number
|
1 |
1 |
Exophthalmos
|
|
|
Additional description: Exophthalmos
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Eye haematoma
|
|
|
Additional description: Eye haematoma
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Eye haemorrhage
|
|
|
Additional description: Eye haemorrhage
|
|
|
subjects affected / exposed
|
3 / 40 (7.50%) |
0 / 26 (0.00%) |
occurrences all number
|
3 |
0 |
Eyelid oedema
|
|
|
Additional description: Eyelid oedema
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Glaucoma
|
|
|
Additional description: Glaucoma
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Lacrimation increased
|
|
|
Additional description: Lacrimation increased
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
2 / 26 (7.69%) |
occurrences all number
|
0 |
2 |
Periorbital oedema
|
|
|
Additional description: Periorbital oedema
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Vision blurred
|
|
|
Additional description: Vision blurred
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Visual impairment
|
|
|
Additional description: Visual impairment
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
1 / 26 (3.85%) |
occurrences all number
|
1 |
2 |
Gastrointestinal disorders
|
|
|
Abdominal discomfort
|
|
|
Additional description: Abdominal discomfort
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
0 / 26 (0.00%) |
occurrences all number
|
2 |
0 |
Abdominal distension
|
|
|
Additional description: Abdominal distension
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Abdominal pain
|
|
|
Additional description: Abdominal pain
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
2 / 26 (7.69%) |
occurrences all number
|
2 |
3 |
Abdominal pain upper
|
|
|
Additional description: Abdominal pain upper
|
|
|
subjects affected / exposed
|
5 / 40 (12.50%) |
4 / 26 (15.38%) |
occurrences all number
|
6 |
5 |
Anal haemorrhage
|
|
|
Additional description: Anal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Aphthous ulcer
|
|
|
Additional description: Aphthous ulcer
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
2 |
0 |
Constipation
|
|
|
Additional description: Constipation
|
|
|
subjects affected / exposed
|
4 / 40 (10.00%) |
2 / 26 (7.69%) |
occurrences all number
|
5 |
2 |
Dental caries
|
|
|
Additional description: Dental caries
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Diarrhoea
|
|
|
Additional description: Diarrhoea
|
|
|
subjects affected / exposed
|
21 / 40 (52.50%) |
9 / 26 (34.62%) |
occurrences all number
|
38 |
15 |
Diverticulum
|
|
|
Additional description: Diverticulum
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Dry mouth
|
|
|
Additional description: Dry mouth
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
2 / 26 (7.69%) |
occurrences all number
|
1 |
2 |
Dyspepsia
|
|
|
Additional description: Dyspepsia
|
|
|
subjects affected / exposed
|
3 / 40 (7.50%) |
2 / 26 (7.69%) |
occurrences all number
|
5 |
2 |
Endocrine disorders
|
|
|
Additional description: Endocrine disorders
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Faecaloma
|
|
|
Additional description: Faecaloma
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Faeces discoloured
|
|
|
Additional description: Faeces discoloured
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Flatulence
|
|
|
Additional description: Flatulence
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
2 / 26 (7.69%) |
occurrences all number
|
2 |
3 |
Gastric ulcer
|
|
|
Additional description: Gastric ulcer
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Gastritis
|
|
|
Additional description: Gastritis
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
1 / 26 (3.85%) |
occurrences all number
|
2 |
1 |
Gastritis erosive
|
|
|
Additional description: Gastritis erosive
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Gastrointestinal disorder
|
|
|
Additional description: Gastrointestinal disorder
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Gastrointestinal pain
|
|
|
Additional description: Gastrointestinal pain
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
0 / 26 (0.00%) |
occurrences all number
|
2 |
0 |
Gastrooesophageal reflux disease
|
|
|
Additional description: Gastrooesophageal reflux disease
|
|
|
subjects affected / exposed
|
3 / 40 (7.50%) |
5 / 26 (19.23%) |
occurrences all number
|
3 |
6 |
Gingival bleeding
|
|
|
Additional description: Gingival bleeding
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Haemorrhoidal haemorrhage
|
|
|
Additional description: Haemorrhoidal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Haemorrhoids
|
|
|
Additional description: Haemorrhoids
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
0 / 26 (0.00%) |
occurrences all number
|
2 |
0 |
Hiatus hernia
|
|
|
Additional description: Hiatus hernia
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
1 / 26 (3.85%) |
occurrences all number
|
1 |
1 |
Inguinal hernia
|
|
|
Additional description: Inguinal hernia
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Large intestine polyp
|
|
|
Additional description: Large intestine polyp
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
2 / 26 (7.69%) |
occurrences all number
|
0 |
2 |
Leukoplakia oral
|
|
|
Additional description: Leukoplakia oral
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Nausea
|
|
|
Additional description: Nausea
|
|
|
subjects affected / exposed
|
12 / 40 (30.00%) |
7 / 26 (26.92%) |
occurrences all number
|
18 |
10 |
Oral dysaesthesia
|
|
|
Additional description: Oral dysaesthesia
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Paraesthesia oral
|
|
|
Additional description: Paraesthesia oral
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Periodontal disease
|
|
|
Additional description: Periodontal disease
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
0 / 26 (0.00%) |
occurrences all number
|
3 |
0 |
Stomatitis
|
|
|
Additional description: Stomatitis
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
0 / 26 (0.00%) |
occurrences all number
|
3 |
0 |
Tooth loss
|
|
|
Additional description: Tooth loss
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
2 |
Toothache
|
|
|
Additional description: Toothache
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
0 / 26 (0.00%) |
occurrences all number
|
2 |
0 |
Skin and subcutaneous tissue disorders
|
|
|
Acne
|
|
|
Additional description: Acne
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
0 / 26 (0.00%) |
occurrences all number
|
2 |
0 |
Actinic keratosis
|
|
|
Additional description: Actinic keratosis
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Alopecia
|
|
|
Additional description: Alopecia
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
1 / 26 (3.85%) |
occurrences all number
|
2 |
1 |
Blood blister
|
|
|
Additional description: Blood blister
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
0 / 26 (0.00%) |
occurrences all number
|
2 |
0 |
Decubitus ulcer
|
|
|
Additional description: Decubitus ulcer
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Dermatitis
|
|
|
Additional description: Dermatitis
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
0 / 26 (0.00%) |
occurrences all number
|
2 |
0 |
Dermatitis allergic
|
|
|
Additional description: Dermatitis allergic
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
0 / 26 (0.00%) |
occurrences all number
|
2 |
0 |
Dry skin
|
|
|
Additional description: Dry skin
|
|
|
subjects affected / exposed
|
3 / 40 (7.50%) |
2 / 26 (7.69%) |
occurrences all number
|
3 |
2 |
Ecchymosis
|
|
|
Additional description: Ecchymosis
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Eczema
|
|
|
Additional description: Eczema
|
|
|
subjects affected / exposed
|
3 / 40 (7.50%) |
1 / 26 (3.85%) |
occurrences all number
|
3 |
1 |
Erythema
|
|
|
Additional description: Erythema
|
|
|
subjects affected / exposed
|
3 / 40 (7.50%) |
1 / 26 (3.85%) |
occurrences all number
|
3 |
2 |
Hyperhidrosis
|
|
|
Additional description: Hyperhidrosis
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
3 / 26 (11.54%) |
occurrences all number
|
2 |
3 |
Hypotrichosis
|
|
|
Additional description: Hypotrichosis
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Nail ridging
|
|
|
Additional description: Nail ridging
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Night sweats
|
|
|
Additional description: Night sweats
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Onychoclasis
|
|
|
Additional description: Onychoclasis
|
|
|
subjects affected / exposed
|
7 / 40 (17.50%) |
1 / 26 (3.85%) |
occurrences all number
|
8 |
1 |
Petechiae
|
|
|
Additional description: Petechiae
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
3 / 26 (11.54%) |
occurrences all number
|
2 |
3 |
Pruritus
|
|
|
Additional description: Pruritus
|
|
|
subjects affected / exposed
|
7 / 40 (17.50%) |
2 / 26 (7.69%) |
occurrences all number
|
7 |
2 |
Pruritus generalised
|
|
|
Additional description: Pruritus generalised
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Psoriasis
|
|
|
Additional description: Psoriasis
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
0 / 26 (0.00%) |
occurrences all number
|
2 |
0 |
Rash
|
|
|
Additional description: Rash
|
|
|
subjects affected / exposed
|
15 / 40 (37.50%) |
8 / 26 (30.77%) |
occurrences all number
|
19 |
8 |
Rash maculo-papular
|
|
|
Additional description: Rash maculo-papular
|
|
|
subjects affected / exposed
|
4 / 40 (10.00%) |
0 / 26 (0.00%) |
occurrences all number
|
6 |
0 |
Rash papular
|
|
|
Additional description: Rash papular
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Skin burning sensation
|
|
|
Additional description: Skin burning sensation
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Skin fissures
|
|
|
Additional description: Skin fissures
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
0 / 26 (0.00%) |
occurrences all number
|
2 |
0 |
Skin lesion
|
|
|
Additional description: Skin lesion
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
0 / 26 (0.00%) |
occurrences all number
|
2 |
0 |
Skin ulcer
|
|
|
Additional description: Skin ulcer
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
5 |
Renal and urinary disorders
|
|
|
Acute kidney injury
|
|
|
Additional description: Acute kidney injury
|
|
|
subjects affected / exposed
|
3 / 40 (7.50%) |
0 / 26 (0.00%) |
occurrences all number
|
4 |
0 |
Chronic kidney disease
|
|
|
Additional description: Chronic kidney disease
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
2 |
0 |
Cystitis noninfective
|
|
|
Additional description: Cystitis noninfective
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
2 |
Dysuria
|
|
|
Additional description: Dysuria
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
1 / 26 (3.85%) |
occurrences all number
|
1 |
1 |
Haematuria
|
|
|
Additional description: Haematuria
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Nocturia
|
|
|
Additional description: Nocturia
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Pollakiuria
|
|
|
Additional description: Pollakiuria
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Strangury
|
|
|
Additional description: Strangury
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Urge incontinence
|
|
|
Additional description: Urge incontinence
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Urinary tract disorder
|
|
|
Additional description: Urinary tract disorder
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Urinary tract obstruction
|
|
|
Additional description: Urinary tract obstruction
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Endocrine disorders
|
|
|
Hyperthyroidism
|
|
|
Additional description: Hyperthyroidism
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Hypothyroidism
|
|
|
Additional description: Hypothyroidism
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
2 / 26 (7.69%) |
occurrences all number
|
1 |
2 |
Thyroid cyst
|
|
|
Additional description: Thyroid cyst
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Thyroid mass
|
|
|
Additional description: Thyroid mass
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Musculoskeletal and connective tissue disorders
|
|
|
Arthralgia
|
|
|
Additional description: Arthralgia
|
|
|
subjects affected / exposed
|
8 / 40 (20.00%) |
5 / 26 (19.23%) |
occurrences all number
|
11 |
7 |
Arthritis
|
|
|
Additional description: Arthritis
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
2 / 26 (7.69%) |
occurrences all number
|
1 |
2 |
Back pain
|
|
|
Additional description: Back pain
|
|
|
subjects affected / exposed
|
7 / 40 (17.50%) |
2 / 26 (7.69%) |
occurrences all number
|
8 |
2 |
Bone pain
|
|
|
Additional description: Bone pain
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Bursitis
|
|
|
Additional description: Bursitis
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Gouty arthritis
|
|
|
Additional description: Gouty arthritis
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Intervertebral disc protrusion
|
|
|
Additional description: Intervertebral disc protrusion
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
1 / 26 (3.85%) |
occurrences all number
|
1 |
1 |
Joint swelling
|
|
|
Additional description: Joint swelling
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
1 / 26 (3.85%) |
occurrences all number
|
1 |
1 |
Muscle spasms
|
|
|
Additional description: Muscle spasms
|
|
|
subjects affected / exposed
|
5 / 40 (12.50%) |
8 / 26 (30.77%) |
occurrences all number
|
10 |
10 |
Muscle tightness
|
|
|
Additional description: Muscle tightness
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Musculoskeletal chest pain
|
|
|
Additional description: Musculoskeletal chest pain
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Musculoskeletal pain
|
|
|
Additional description: Musculoskeletal pain
|
|
|
subjects affected / exposed
|
3 / 40 (7.50%) |
2 / 26 (7.69%) |
occurrences all number
|
4 |
2 |
Myalgia
|
|
|
Additional description: Myalgia
|
|
|
subjects affected / exposed
|
10 / 40 (25.00%) |
2 / 26 (7.69%) |
occurrences all number
|
12 |
2 |
Myosclerosis
|
|
|
Additional description: Myosclerosis
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Neck pain
|
|
|
Additional description: Neck pain
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
0 / 26 (0.00%) |
occurrences all number
|
2 |
0 |
Osteoarthritis
|
|
|
Additional description: Osteoarthritis
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Osteoporosis
|
|
|
Additional description: Osteoporosis
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
0 / 26 (0.00%) |
occurrences all number
|
2 |
0 |
Pain in extremity
|
|
|
Additional description: Pain in extremity
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
2 / 26 (7.69%) |
occurrences all number
|
2 |
3 |
Plantar fasciitis
|
|
|
Additional description: Plantar fasciitis
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Polyarthritis
|
|
|
Additional description: Polyarthritis
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Synovial cyst
|
|
|
Additional description: Synovial cyst
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
1 / 26 (3.85%) |
occurrences all number
|
2 |
1 |
Tendon disorder
|
|
|
Additional description: Tendon disorder
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Tendonitis
|
|
|
Additional description: Tendonitis
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
0 / 26 (0.00%) |
occurrences all number
|
2 |
0 |
Trigger finger
|
|
|
Additional description: Trigger finger
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Infections and infestations
|
|
|
Abscess
|
|
|
Additional description: Abscess
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Abscess limb
|
|
|
Additional description: Abscess limb
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
1 / 26 (3.85%) |
occurrences all number
|
1 |
1 |
Anal abscess
|
|
|
Additional description: Anal abscess
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Angular cheilitis
|
|
|
Additional description: Angular cheilitis
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
0 / 26 (0.00%) |
occurrences all number
|
2 |
0 |
Bacterial infection
|
|
|
Additional description: Bacterial infection
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
1 / 26 (3.85%) |
occurrences all number
|
2 |
1 |
Balanitis candida
|
|
|
Additional description: Balanitis candida
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Borrelia infection
|
|
|
Additional description: Borrelia infection
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Bronchitis
|
|
|
Additional description: Bronchitis
|
|
|
subjects affected / exposed
|
14 / 40 (35.00%) |
5 / 26 (19.23%) |
occurrences all number
|
16 |
8 |
Bursitis infective
|
|
|
Additional description: Bursitis infective
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
1 / 26 (3.85%) |
occurrences all number
|
1 |
1 |
Chronic sinusitis
|
|
|
Additional description: Chronic sinusitis
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Conjunctivitis
|
|
|
Additional description: Conjunctivitis
|
|
|
subjects affected / exposed
|
3 / 40 (7.50%) |
4 / 26 (15.38%) |
occurrences all number
|
3 |
4 |
Cystitis
|
|
|
Additional description: Cystitis
|
|
|
subjects affected / exposed
|
4 / 40 (10.00%) |
3 / 26 (11.54%) |
occurrences all number
|
5 |
10 |
Diarrhoea infectious
|
|
|
Additional description: Diarrhoea infectious
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Enterocolitis infectious
|
|
|
Additional description: Enterocolitis infectious
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Erythema migrans
|
|
|
Additional description: Erythema migrans
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
0 / 26 (0.00%) |
occurrences all number
|
2 |
0 |
Eyelid infection
|
|
|
Additional description: Eyelid infection
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Febrile Infection
|
|
|
Additional description: Febrile Infection
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Gastric infection
|
|
|
Additional description: Gastric infection
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Gastroenteritis
|
|
|
Additional description: Gastroenteritis
|
|
|
subjects affected / exposed
|
3 / 40 (7.50%) |
0 / 26 (0.00%) |
occurrences all number
|
5 |
0 |
Gastroenteritis viral
|
|
|
Additional description: Gastroenteritis viral
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Gastrointestinal infection
|
|
|
Additional description: Gastrointestinal infection
|
|
|
subjects affected / exposed
|
3 / 40 (7.50%) |
1 / 26 (3.85%) |
occurrences all number
|
3 |
1 |
Genital infection fungal
|
|
|
Additional description: Genital infection fungal
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Gingivitis
|
|
|
Additional description: Gingivitis
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Herpes virus infection
|
|
|
Additional description: Herpes virus infection
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Herpes zoster
|
|
|
Additional description: Herpes zoster
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Infected bite
|
|
|
Additional description: Infected bite
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Infection
|
|
|
Additional description: Infection
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
2 / 26 (7.69%) |
occurrences all number
|
2 |
3 |
Infection susceptibility increased
|
|
|
Additional description: Infection susceptibility increased
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
0 / 26 (0.00%) |
occurrences all number
|
2 |
0 |
Influenza
|
|
|
Additional description: Influenza
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
2 / 26 (7.69%) |
occurrences all number
|
1 |
2 |
Lip infection
|
|
|
Additional description: Lip infection
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Localised infection
|
|
|
Additional description: Localised infection
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Nasopharyngitis
|
|
|
Additional description: Nasopharyngitis
|
|
|
subjects affected / exposed
|
21 / 40 (52.50%) |
8 / 26 (30.77%) |
occurrences all number
|
32 |
13 |
Neutropenic infection
|
|
|
Additional description: Neutropenic infection
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
2 |
Onychomycosis
|
|
|
Additional description: Onychomycosis
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Oral candidiasis
|
|
|
Additional description: Oral candidiasis
|
|
|
subjects affected / exposed
|
3 / 40 (7.50%) |
1 / 26 (3.85%) |
occurrences all number
|
3 |
1 |
Oral herpes
|
|
|
Additional description: Oral herpes
|
|
|
subjects affected / exposed
|
5 / 40 (12.50%) |
2 / 26 (7.69%) |
occurrences all number
|
7 |
2 |
Osteomyelitis
|
|
|
Additional description: Osteomyelitis
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Otitis media
|
|
|
Additional description: Otitis media
|
|
|
subjects affected / exposed
|
3 / 40 (7.50%) |
0 / 26 (0.00%) |
occurrences all number
|
3 |
0 |
Paronychia
|
|
|
Additional description: Paronychia
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
0 / 26 (0.00%) |
occurrences all number
|
5 |
0 |
Parotitis
|
|
|
Additional description: Parotitis
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
1 / 26 (3.85%) |
occurrences all number
|
1 |
1 |
Periodontitis
|
|
|
Additional description: Periodontitis
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
0 / 26 (0.00%) |
occurrences all number
|
2 |
0 |
Pertussis
|
|
|
Additional description: Pertussis
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Pharyngitis
|
|
|
Additional description: Pharyngitis
|
|
|
subjects affected / exposed
|
5 / 40 (12.50%) |
2 / 26 (7.69%) |
occurrences all number
|
7 |
2 |
Pneumonia
|
|
|
Additional description: Pneumonia
|
|
|
subjects affected / exposed
|
4 / 40 (10.00%) |
3 / 26 (11.54%) |
occurrences all number
|
4 |
3 |
Pseudomonas infection
|
|
|
Additional description: Pseudomonas infection
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Respiratory tract infection
|
|
|
Additional description: Respiratory tract infection
|
|
|
subjects affected / exposed
|
3 / 40 (7.50%) |
4 / 26 (15.38%) |
occurrences all number
|
3 |
5 |
Rhinitis
|
|
|
Additional description: Rhinitis
|
|
|
subjects affected / exposed
|
4 / 40 (10.00%) |
2 / 26 (7.69%) |
occurrences all number
|
6 |
2 |
Root canal infection
|
|
|
Additional description: Root canal infection
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Sinusitis
|
|
|
Additional description: Sinusitis
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
3 / 26 (11.54%) |
occurrences all number
|
3 |
6 |
Skin infection
|
|
|
Additional description: Skin infection
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Soft tissue infection
|
|
|
Additional description: Soft tissue infection
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Systemic infection
|
|
|
Additional description: Systemic infection
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Tonsillitis
|
|
|
Additional description: Tonsillitis
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Upper respiratory tract infection
|
|
|
Additional description: Upper respiratory tract infection
|
|
|
subjects affected / exposed
|
9 / 40 (22.50%) |
2 / 26 (7.69%) |
occurrences all number
|
11 |
3 |
Urinary tract infection
|
|
|
Additional description: Urinary tract infection
|
|
|
subjects affected / exposed
|
7 / 40 (17.50%) |
1 / 26 (3.85%) |
occurrences all number
|
11 |
4 |
Viral oesophagitis
|
|
|
Additional description: Viral oesophagitis
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Viral pharyngitis
|
|
|
Additional description: Viral pharyngitis
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Wound infection
|
|
|
Additional description: Wound infection
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Metabolism and nutrition disorders
|
|
|
Abnormal loss of weight
|
|
|
Additional description: Abnormal loss of weight
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Decreased appetite
|
|
|
Additional description: Decreased appetite
|
|
|
subjects affected / exposed
|
2 / 40 (5.00%) |
0 / 26 (0.00%) |
occurrences all number
|
2 |
0 |
Gout
|
|
|
Additional description: Gout
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
1 / 26 (3.85%) |
occurrences all number
|
1 |
1 |
Hypercalcaemia
|
|
|
Additional description: Hypercalcaemia
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |
Hypercholesterolaemia
|
|
|
Additional description: Hypercholesterolaemia
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Hyperglycaemia
|
|
|
Additional description: Hyperglycaemia
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Hyperkalaemia
|
|
|
Additional description: Hyperkalaemia
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
1 / 26 (3.85%) |
occurrences all number
|
1 |
1 |
Hyperuricaemia
|
|
|
Additional description: Hyperuricaemia
|
|
|
subjects affected / exposed
|
4 / 40 (10.00%) |
1 / 26 (3.85%) |
occurrences all number
|
5 |
1 |
Hypokalaemia
|
|
|
Additional description: Hypokalaemia
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
2 / 26 (7.69%) |
occurrences all number
|
1 |
3 |
Iron overload
|
|
|
Additional description: Iron overload
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Vitamin D deficiency
|
|
|
Additional description: Vitamin D deficiency
|
|
|
subjects affected / exposed
|
1 / 40 (2.50%) |
0 / 26 (0.00%) |
occurrences all number
|
1 |
0 |
Weight fluctuation
|
|
|
Additional description: Weight fluctuation
|
|
|
subjects affected / exposed
|
0 / 40 (0.00%) |
1 / 26 (3.85%) |
occurrences all number
|
0 |
1 |