Non-serious adverse events
|
Abiraterone Acetate + Prednisone (AAP) |
Placebo to AA |
Placebo |
Total subjects affected by non serious adverse events
|
|
|
|
subjects affected / exposed
|
540 / 542 (99.63%) |
88 / 93 (94.62%) |
524 / 540 (97.04%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
Acoustic Neuroma
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Acrochordon
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
4 / 540 (0.74%) |
occurrences all number
|
2 |
0 |
4 |
Atypical Fibroxanthoma
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Basal Cell Carcinoma
|
|
|
|
subjects affected / exposed
|
9 / 542 (1.66%) |
2 / 93 (2.15%) |
10 / 540 (1.85%) |
occurrences all number
|
10 |
2 |
13 |
Benign Neoplasm of Skin
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Bladder Neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Bowen's Disease
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Cancer Pain
|
|
|
|
subjects affected / exposed
|
14 / 542 (2.58%) |
0 / 93 (0.00%) |
16 / 540 (2.96%) |
occurrences all number
|
18 |
0 |
26 |
Chronic Lymphocytic Leukaemia
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Colon Adenoma
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
1 / 93 (1.08%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
1 |
1 |
Cystic Lymphangioma
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Haemangioma
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Keratoacanthoma
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
4 |
Lip Neoplasm Malignant Stage Unspecified
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Lipoma
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
1 / 93 (1.08%) |
3 / 540 (0.56%) |
occurrences all number
|
4 |
1 |
3 |
Malignant Melanoma
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
4 |
0 |
0 |
Melanocytic Naevus
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
1 |
1 |
Metastases to Bone
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
2 |
Metastatic Pain
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Neoplasm Malignant
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
2 |
Neurilemmoma
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Rectal Cancer
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Renal Cell Carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Seborrhoeic Keratosis
|
|
|
|
subjects affected / exposed
|
6 / 542 (1.11%) |
0 / 93 (0.00%) |
4 / 540 (0.74%) |
occurrences all number
|
7 |
0 |
4 |
Skin Papilloma
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
4 / 540 (0.74%) |
occurrences all number
|
3 |
0 |
4 |
Spinal Cord Neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Squamous Cell Carcinoma
|
|
|
|
subjects affected / exposed
|
11 / 542 (2.03%) |
1 / 93 (1.08%) |
3 / 540 (0.56%) |
occurrences all number
|
16 |
3 |
4 |
Squamous Cell Carcinoma of Skin
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Tongue Neoplasm Malignant Stage Unspecified
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Transitional Cell Carcinoma
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Tumour Pain
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
1 / 93 (1.08%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
1 |
1 |
Vocal Cord Neoplasm
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Vascular disorders
|
|
|
|
Angiodysplasia
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Aortic Aneurysm
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Aortic Arteriosclerosis
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Arterial Thrombosis Limb
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Capillary Fragility
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
2 |
0 |
1 |
Circulatory Collapse
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
2 |
Deep Vein Thrombosis
|
|
|
|
subjects affected / exposed
|
8 / 542 (1.48%) |
1 / 93 (1.08%) |
6 / 540 (1.11%) |
occurrences all number
|
8 |
1 |
6 |
Flushing
|
|
|
|
subjects affected / exposed
|
9 / 542 (1.66%) |
0 / 93 (0.00%) |
5 / 540 (0.93%) |
occurrences all number
|
9 |
0 |
5 |
Gastrointestinal Arteriovenous Malformation
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Haematoma
|
|
|
|
subjects affected / exposed
|
22 / 542 (4.06%) |
1 / 93 (1.08%) |
6 / 540 (1.11%) |
occurrences all number
|
32 |
1 |
6 |
Haemorrhage
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Hot Flush
|
|
|
|
subjects affected / exposed
|
124 / 542 (22.88%) |
6 / 93 (6.45%) |
100 / 540 (18.52%) |
occurrences all number
|
153 |
6 |
122 |
Hypertension
|
|
|
|
subjects affected / exposed
|
129 / 542 (23.80%) |
6 / 93 (6.45%) |
73 / 540 (13.52%) |
occurrences all number
|
182 |
8 |
94 |
Hypotension
|
|
|
|
subjects affected / exposed
|
24 / 542 (4.43%) |
3 / 93 (3.23%) |
16 / 540 (2.96%) |
occurrences all number
|
24 |
4 |
19 |
Intermittent Claudication
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
1 |
0 |
2 |
Lymphoedema
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
4 |
0 |
1 |
Microangiopathy
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Orthostatic Hypotension
|
|
|
|
subjects affected / exposed
|
5 / 542 (0.92%) |
2 / 93 (2.15%) |
4 / 540 (0.74%) |
occurrences all number
|
5 |
2 |
4 |
Pallor
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
1 / 93 (1.08%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
1 |
1 |
Peripheral Ischaemia
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Peripheral Vascular Disorder
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Phlebitis
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
2 |
0 |
1 |
Thrombophlebitis
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
2 |
0 |
1 |
Thrombophlebitis Superficial
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Thrombosis
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
3 |
0 |
0 |
Varicose Vein
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
4 / 540 (0.74%) |
occurrences all number
|
1 |
0 |
4 |
Vein Disorder
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Venous Thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Venous Thrombosis Limb
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Surgical and medical procedures
|
|
|
|
Cataract Operation
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
2 |
Knee Arthroplasty
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Skin Neoplasm Excision
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Transurethral Prostatectomy
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Ureteral Stent Insertion
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Wisdom Teeth Removal
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
General disorders and administration site conditions
|
|
|
|
Abasia
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Adverse Drug Reaction
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
0 |
0 |
2 |
Asthenia
|
|
|
|
subjects affected / exposed
|
46 / 542 (8.49%) |
1 / 93 (1.08%) |
46 / 540 (8.52%) |
occurrences all number
|
65 |
1 |
66 |
Axillary Pain
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
1 |
0 |
2 |
Catheter Related Complication
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
0 |
0 |
7 |
Catheter Site Erythema
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Catheter Site Haematoma
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Catheter Site Haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Catheter Site Inflammation
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Catheter Site Pain
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
2 |
0 |
8 |
Chest Discomfort
|
|
|
|
subjects affected / exposed
|
10 / 542 (1.85%) |
0 / 93 (0.00%) |
7 / 540 (1.30%) |
occurrences all number
|
10 |
0 |
8 |
Chest Pain
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
1 / 93 (1.08%) |
7 / 540 (1.30%) |
occurrences all number
|
2 |
1 |
8 |
Chills
|
|
|
|
subjects affected / exposed
|
15 / 542 (2.77%) |
2 / 93 (2.15%) |
14 / 540 (2.59%) |
occurrences all number
|
17 |
2 |
17 |
Cyst
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
4 |
0 |
2 |
Discomfort
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Disease Progression
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
2 / 93 (2.15%) |
1 / 540 (0.19%) |
occurrences all number
|
3 |
2 |
1 |
Energy Increased
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Extravasation
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Face Oedema
|
|
|
|
subjects affected / exposed
|
5 / 542 (0.92%) |
0 / 93 (0.00%) |
4 / 540 (0.74%) |
occurrences all number
|
6 |
0 |
4 |
Facial Pain
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
3 |
0 |
0 |
Fatigue
|
|
|
|
subjects affected / exposed
|
243 / 542 (44.83%) |
27 / 93 (29.03%) |
200 / 540 (37.04%) |
occurrences all number
|
448 |
35 |
314 |
Feeling Abnormal
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Feeling Cold
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
1 / 93 (1.08%) |
1 / 540 (0.19%) |
occurrences all number
|
2 |
1 |
1 |
Feeling Hot
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
2 |
Feeling Jittery
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
2 |
Gait Disturbance
|
|
|
|
subjects affected / exposed
|
10 / 542 (1.85%) |
0 / 93 (0.00%) |
10 / 540 (1.85%) |
occurrences all number
|
12 |
0 |
12 |
General Physical Health Deterioration
|
|
|
|
subjects affected / exposed
|
5 / 542 (0.92%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
8 |
0 |
3 |
Generalised Oedema
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
2 |
0 |
2 |
Hangover
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Hernia
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Hernia Pain
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
3 |
1 |
0 |
Hunger
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Hyperthermia
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
3 |
0 |
1 |
Hypothermia
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Impaired Healing
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
2 |
0 |
2 |
Implant Site Inflammation
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Implant Site Reaction
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Inflammation
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
1 / 93 (1.08%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
1 |
1 |
Influenza Like Illness
|
|
|
|
subjects affected / exposed
|
20 / 542 (3.69%) |
4 / 93 (4.30%) |
10 / 540 (1.85%) |
occurrences all number
|
27 |
4 |
14 |
Infusion Site Bruising
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Injection Site Bruising
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Injection Site Haematoma
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Injection Site Haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Injection Site Pain
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Injection Site Reaction
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Irritability
|
|
|
|
subjects affected / exposed
|
7 / 542 (1.29%) |
0 / 93 (0.00%) |
5 / 540 (0.93%) |
occurrences all number
|
7 |
0 |
5 |
Local Swelling
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
2 |
Localised Oedema
|
|
|
|
subjects affected / exposed
|
5 / 542 (0.92%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
5 |
0 |
1 |
Malaise
|
|
|
|
subjects affected / exposed
|
10 / 542 (1.85%) |
0 / 93 (0.00%) |
7 / 540 (1.30%) |
occurrences all number
|
12 |
0 |
7 |
Mass
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
1 / 93 (1.08%) |
2 / 540 (0.37%) |
occurrences all number
|
2 |
1 |
2 |
Mucosal Inflammation
|
|
|
|
subjects affected / exposed
|
6 / 542 (1.11%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
9 |
0 |
2 |
Multi-Organ Failure
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Nodule
|
|
|
|
subjects affected / exposed
|
5 / 542 (0.92%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
6 |
0 |
1 |
Non-Cardiac Chest Pain
|
|
|
|
subjects affected / exposed
|
13 / 542 (2.40%) |
1 / 93 (1.08%) |
11 / 540 (2.04%) |
occurrences all number
|
13 |
1 |
14 |
Oedema Peripheral
|
|
|
|
subjects affected / exposed
|
148 / 542 (27.31%) |
22 / 93 (23.66%) |
119 / 540 (22.04%) |
occurrences all number
|
269 |
24 |
198 |
Pain
|
|
|
|
subjects affected / exposed
|
27 / 542 (4.98%) |
0 / 93 (0.00%) |
16 / 540 (2.96%) |
occurrences all number
|
28 |
0 |
18 |
Papillitis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Pelvic Mass
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Performance Status Decreased
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Peripheral Coldness
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Pitting Oedema
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
0 / 93 (0.00%) |
5 / 540 (0.93%) |
occurrences all number
|
4 |
0 |
6 |
Puncture Site Reaction
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Pyrexia
|
|
|
|
subjects affected / exposed
|
54 / 542 (9.96%) |
5 / 93 (5.38%) |
33 / 540 (6.11%) |
occurrences all number
|
69 |
7 |
45 |
Sensation of Pressure
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
4 |
0 |
0 |
Suprapubic Pain
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
3 |
0 |
1 |
Temperature Intolerance
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
1 |
0 |
2 |
Thirst
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Venipuncture Site Swelling
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Vessel Puncture Site Haematoma
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
2 |
0 |
1 |
Wound Necrosis
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
2 |
Xerosis
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Immune system disorders
|
|
|
|
Contrast Media Allergy
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
2 |
Drug Hypersensitivity
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Hypersensitivity
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
4 / 540 (0.74%) |
occurrences all number
|
3 |
0 |
4 |
Seasonal Allergy
|
|
|
|
subjects affected / exposed
|
7 / 542 (1.29%) |
2 / 93 (2.15%) |
5 / 540 (0.93%) |
occurrences all number
|
8 |
2 |
5 |
Reproductive system and breast disorders
|
|
|
|
Balanitis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Breast Mass
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Breast Pain
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
3 |
0 |
2 |
Breast Tenderness
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
0 |
0 |
4 |
Epididymal Cyst
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Erectile Dysfunction
|
|
|
|
subjects affected / exposed
|
9 / 542 (1.66%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
9 |
0 |
2 |
Genital Pain
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Nipple Pain
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Oedema Genital
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Penile Discharge
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Penile Oedema
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Penile Pain
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
6 |
0 |
2 |
Penile Size Reduced
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Perineal Pain
|
|
|
|
subjects affected / exposed
|
6 / 542 (1.11%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
7 |
0 |
3 |
Prostate Induration
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Prostatic Obstruction
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
0 |
0 |
2 |
Prostatic Pain
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Prostatism
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Prostatitis
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
2 |
0 |
1 |
Scrotal Haematocoele
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Scrotal Oedema
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
3 |
0 |
1 |
Scrotal Pain
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
1 / 93 (1.08%) |
1 / 540 (0.19%) |
occurrences all number
|
3 |
1 |
1 |
Testicular Atrophy
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Testicular Disorder
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Testicular Pain
|
|
|
|
subjects affected / exposed
|
7 / 542 (1.29%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
8 |
0 |
2 |
Testicular Swelling
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
4 |
Testis Discomfort
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
Asphyxia
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Asthma
|
|
|
|
subjects affected / exposed
|
5 / 542 (0.92%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
5 |
0 |
1 |
Atelectasis
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
3 |
0 |
3 |
Bronchopneumopathy
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Bronchospasm
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
2 |
0 |
1 |
Chest Discomfort
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
3 |
0 |
0 |
Chest Pain
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Chronic Obstructive Pulmonary Disease
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
2 / 93 (2.15%) |
4 / 540 (0.74%) |
occurrences all number
|
4 |
2 |
4 |
Cough
|
|
|
|
subjects affected / exposed
|
106 / 542 (19.56%) |
11 / 93 (11.83%) |
74 / 540 (13.70%) |
occurrences all number
|
146 |
14 |
92 |
Dry Throat
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Dysphonia
|
|
|
|
subjects affected / exposed
|
17 / 542 (3.14%) |
0 / 93 (0.00%) |
6 / 540 (1.11%) |
occurrences all number
|
18 |
0 |
6 |
Dyspnoea
|
|
|
|
subjects affected / exposed
|
71 / 542 (13.10%) |
7 / 93 (7.53%) |
52 / 540 (9.63%) |
occurrences all number
|
116 |
8 |
74 |
Dyspnoea Exertional
|
|
|
|
subjects affected / exposed
|
16 / 542 (2.95%) |
0 / 93 (0.00%) |
13 / 540 (2.41%) |
occurrences all number
|
21 |
0 |
13 |
Emphysema
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
1 |
0 |
3 |
Epistaxis
|
|
|
|
subjects affected / exposed
|
12 / 542 (2.21%) |
1 / 93 (1.08%) |
9 / 540 (1.67%) |
occurrences all number
|
13 |
1 |
10 |
Haemoptysis
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
1 |
0 |
Hiccups
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Hypoxia
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
3 |
0 |
2 |
Increased Bronchial Secretion
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Increased Upper Airway Secretion
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
0 |
0 |
3 |
Interstitial Lung Disease
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Lung Infiltration
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Nasal Congestion
|
|
|
|
subjects affected / exposed
|
20 / 542 (3.69%) |
0 / 93 (0.00%) |
14 / 540 (2.59%) |
occurrences all number
|
26 |
0 |
18 |
Nasal Mucosal Disorder
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Nasal Septum Deviation
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Orthopnoea
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Paranasal Sinus Hypersecretion
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Pharyngeal Erythema
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Pharyngolaryngeal Discomfort
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Pharyngolaryngeal Pain
|
|
|
|
subjects affected / exposed
|
21 / 542 (3.87%) |
4 / 93 (4.30%) |
13 / 540 (2.41%) |
occurrences all number
|
29 |
4 |
14 |
Pleural Effusion
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
5 |
0 |
3 |
Pleuritic Pain
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Pneumonia Aspiration
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Pneumonitis
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Pneumothorax
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Postnasal Drip
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
3 |
0 |
3 |
Productive Cough
|
|
|
|
subjects affected / exposed
|
17 / 542 (3.14%) |
0 / 93 (0.00%) |
11 / 540 (2.04%) |
occurrences all number
|
23 |
0 |
13 |
Prolonged Expiration
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Pulmonary Embolism
|
|
|
|
subjects affected / exposed
|
5 / 542 (0.92%) |
0 / 93 (0.00%) |
8 / 540 (1.48%) |
occurrences all number
|
5 |
0 |
9 |
Pulmonary Haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Pulmonary Hypertension
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Rales
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
0 / 93 (0.00%) |
4 / 540 (0.74%) |
occurrences all number
|
4 |
0 |
4 |
Respiratory Distress
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Respiratory Failure
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
3 |
0 |
0 |
Respiratory Tract Congestion
|
|
|
|
subjects affected / exposed
|
10 / 542 (1.85%) |
0 / 93 (0.00%) |
4 / 540 (0.74%) |
occurrences all number
|
14 |
0 |
4 |
Respiratory Tract Haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Rhinitis
|
|
|
|
subjects affected / exposed
|
9 / 542 (1.66%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
12 |
0 |
4 |
Rhinitis Allergic
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
2 |
0 |
2 |
Rhinorrhoea
|
|
|
|
subjects affected / exposed
|
13 / 542 (2.40%) |
0 / 93 (0.00%) |
9 / 540 (1.67%) |
occurrences all number
|
14 |
0 |
9 |
Rhonchi
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
3 |
0 |
0 |
Sinus Congestion
|
|
|
|
subjects affected / exposed
|
9 / 542 (1.66%) |
1 / 93 (1.08%) |
4 / 540 (0.74%) |
occurrences all number
|
21 |
1 |
4 |
Sinus Polyp
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Sleep Apnoea Syndrome
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
2 |
0 |
2 |
Sputum Discoloured
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Tachypnoea
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Throat Irritation
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Tracheal Pain
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Upper Respiratory Tract Congestion
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
1 |
0 |
2 |
Wheezing
|
|
|
|
subjects affected / exposed
|
8 / 542 (1.48%) |
2 / 93 (2.15%) |
7 / 540 (1.30%) |
occurrences all number
|
9 |
2 |
7 |
Psychiatric disorders
|
|
|
|
Abnormal Dreams
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Affect Lability
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Affective Disorder
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
0 |
0 |
2 |
Aggression
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
2 |
0 |
1 |
Agitation
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
0 / 93 (0.00%) |
5 / 540 (0.93%) |
occurrences all number
|
4 |
0 |
6 |
Alcoholism
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Anxiety
|
|
|
|
subjects affected / exposed
|
30 / 542 (5.54%) |
4 / 93 (4.30%) |
23 / 540 (4.26%) |
occurrences all number
|
38 |
4 |
25 |
Bipolar Disorder
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Bulimia Nervosa
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Claustrophobia
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Confusional State
|
|
|
|
subjects affected / exposed
|
7 / 542 (1.29%) |
2 / 93 (2.15%) |
10 / 540 (1.85%) |
occurrences all number
|
7 |
2 |
13 |
Delirium
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
2 |
0 |
1 |
Depressed Mood
|
|
|
|
subjects affected / exposed
|
12 / 542 (2.21%) |
1 / 93 (1.08%) |
7 / 540 (1.30%) |
occurrences all number
|
16 |
1 |
8 |
Depression
|
|
|
|
subjects affected / exposed
|
32 / 542 (5.90%) |
3 / 93 (3.23%) |
19 / 540 (3.52%) |
occurrences all number
|
41 |
3 |
20 |
Disorientation
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Elevated Mood
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Emotional Disorder
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Hallucination, Visual
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Impatience
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Insomnia
|
|
|
|
subjects affected / exposed
|
82 / 542 (15.13%) |
5 / 93 (5.38%) |
62 / 540 (11.48%) |
occurrences all number
|
112 |
5 |
67 |
Libido Decreased
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
2 |
0 |
1 |
Loss of Libido
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Mania
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Mental Disorder
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Mental Disorder Due to A General Medical Condition
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Middle Insomnia
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Mood Altered
|
|
|
|
subjects affected / exposed
|
8 / 542 (1.48%) |
0 / 93 (0.00%) |
8 / 540 (1.48%) |
occurrences all number
|
9 |
0 |
8 |
Mood Swings
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
4 / 540 (0.74%) |
occurrences all number
|
1 |
0 |
4 |
Nervousness
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Panic Attack
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Pressure of Speech
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Restlessness
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Seasonal Affective Disorder
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Sleep Disorder
|
|
|
|
subjects affected / exposed
|
5 / 542 (0.92%) |
1 / 93 (1.08%) |
7 / 540 (1.30%) |
occurrences all number
|
6 |
1 |
7 |
Somnambulism
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Stress
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Suicidal Ideation
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Suspiciousness
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Tearfulness
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Investigations
|
|
|
|
Activated Partial Thromboplastin Time Prolonged
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Activated Partial Thromboplastin Time Shortened
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Alanine Aminotransferase Increased
|
|
|
|
subjects affected / exposed
|
70 / 542 (12.92%) |
3 / 93 (3.23%) |
26 / 540 (4.81%) |
occurrences all number
|
167 |
6 |
40 |
Aspartate Aminotransferase Increased
|
|
|
|
subjects affected / exposed
|
63 / 542 (11.62%) |
4 / 93 (4.30%) |
25 / 540 (4.63%) |
occurrences all number
|
114 |
4 |
35 |
Blood Alkaline Phosphatase Increased
|
|
|
|
subjects affected / exposed
|
22 / 542 (4.06%) |
4 / 93 (4.30%) |
25 / 540 (4.63%) |
occurrences all number
|
43 |
4 |
36 |
Blood Amylase Increased
|
|
|
|
subjects affected / exposed
|
8 / 542 (1.48%) |
2 / 93 (2.15%) |
4 / 540 (0.74%) |
occurrences all number
|
19 |
7 |
10 |
Blood Bicarbonate Decreased
|
|
|
|
subjects affected / exposed
|
5 / 542 (0.92%) |
1 / 93 (1.08%) |
2 / 540 (0.37%) |
occurrences all number
|
5 |
1 |
2 |
Blood Calcium Decreased
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
1 / 93 (1.08%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
1 |
1 |
Blood Calcium Increased
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
0 |
0 |
2 |
Blood Chloride Decreased
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Blood Cortisol Decreased
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Blood Creatinine Increased
|
|
|
|
subjects affected / exposed
|
21 / 542 (3.87%) |
2 / 93 (2.15%) |
15 / 540 (2.78%) |
occurrences all number
|
30 |
2 |
22 |
Blood Folate Decreased
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Blood Glucose Fluctuation
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Blood Lactate Dehydrogenase Increased
|
|
|
|
subjects affected / exposed
|
6 / 542 (1.11%) |
0 / 93 (0.00%) |
6 / 540 (1.11%) |
occurrences all number
|
7 |
0 |
7 |
Blood Magnesium Decreased
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Blood Magnesium Increased
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Blood Parathyroid Hormone Increased
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Blood Phosphorus Decreased
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Blood Thyroid Stimulating Hormone Decreased
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Blood Urea Increased
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
2 |
0 |
2 |
Blood Uric Acid Decreased
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Blood Uric Acid Increased
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
5 / 540 (0.93%) |
occurrences all number
|
2 |
0 |
9 |
Body Temperature Increased
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
4 |
0 |
1 |
Brain Natriuretic Peptide Increased
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
4 |
0 |
0 |
Breath Sounds Abnormal
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
2 |
0 |
3 |
Carbon Dioxide Increased
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Cardiac Murmur
|
|
|
|
subjects affected / exposed
|
8 / 542 (1.48%) |
1 / 93 (1.08%) |
5 / 540 (0.93%) |
occurrences all number
|
13 |
1 |
5 |
Electrocardiogram Abnormal
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Ejection Fraction Decreased
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Electrocardiogram Pr Prolongation
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Electrocardiogram QT Prolonged
|
|
|
|
subjects affected / exposed
|
8 / 542 (1.48%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
11 |
0 |
4 |
Electrocardiogram St Segment Depression
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Electrocardiogram QT Shortened
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Electrocardiogram T Wave Inversion
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Gamma-Glutamyltransferase Increased
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
4 / 540 (0.74%) |
occurrences all number
|
5 |
0 |
6 |
Glomerular Filtration Rate Decreased
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Haematocrit Decreased
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
5 |
0 |
3 |
Heart Rate Increased
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Heart Rate Irregular
|
|
|
|
subjects affected / exposed
|
5 / 542 (0.92%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
5 |
0 |
0 |
Hepatic Enzyme Increased
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
4 |
0 |
1 |
Inspiratory Capacity Decreased
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
3 |
0 |
0 |
International Normalised Ratio Decreased
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
International Normalised Ratio Increased
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Intraocular Pressure Increased
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
1 / 93 (1.08%) |
2 / 540 (0.37%) |
occurrences all number
|
1 |
1 |
2 |
Lasegue's Test Positive
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Lipase Increased
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
4 |
0 |
6 |
Liver Function Test Abnormal
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
5 |
0 |
0 |
Liver Palpable Subcostal
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Lymph Node Palpable
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
2 |
0 |
2 |
Lymphocyte Count Decreased
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
7 |
0 |
3 |
Lymphocyte Count Increased
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Lymphocyte Percentage Decreased
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
5 |
0 |
2 |
Neutrophil Count Decreased
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
1 / 93 (1.08%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
1 |
1 |
Neutrophil Count Increased
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Neutrophil Percentage Decreased
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Oxygen Saturation Decreased
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Platelet Count Decreased
|
|
|
|
subjects affected / exposed
|
5 / 542 (0.92%) |
1 / 93 (1.08%) |
1 / 540 (0.19%) |
occurrences all number
|
10 |
1 |
1 |
Platelet Count Increased
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
1 |
1 |
Prostatic Specific Antigen Increased
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
0 |
0 |
3 |
Protein Total Increased
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Prothrombin Time Prolonged
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Prothrombin Time Shortened
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
QRS Axis Abnormal
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Red Blood Cell Count Decreased
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
5 |
0 |
1 |
Troponin I Increased
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Urinary Sediment Abnormal
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Urinary Sediment Present
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Urine Colour Abnormal
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
2 |
0 |
1 |
Urine Output Increased
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
2 |
0 |
2 |
Vitamin B12 Decreased
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Vitamin D Decreased
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Waist Circumference Increased
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
4 / 540 (0.74%) |
occurrences all number
|
2 |
0 |
4 |
Weight Decreased
|
|
|
|
subjects affected / exposed
|
42 / 542 (7.75%) |
6 / 93 (6.45%) |
27 / 540 (5.00%) |
occurrences all number
|
66 |
6 |
38 |
Weight Increased
|
|
|
|
subjects affected / exposed
|
29 / 542 (5.35%) |
2 / 93 (2.15%) |
40 / 540 (7.41%) |
occurrences all number
|
43 |
2 |
48 |
White Blood Cell Count Decreased
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
6 |
0 |
3 |
White Blood Cell Count Increased
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
2 / 540 (0.37%) |
occurrences all number
|
0 |
2 |
3 |
Injury, poisoning and procedural complications
|
|
|
|
Accident at Home
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Accidental Overdose
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
0 |
0 |
2 |
Alcohol Poisoning
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Animal Bite
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Arthropod Bite
|
|
|
|
subjects affected / exposed
|
8 / 542 (1.48%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
8 |
0 |
3 |
Arthropod Sting
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
1 |
0 |
2 |
Back Injury
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
1 / 93 (1.08%) |
3 / 540 (0.56%) |
occurrences all number
|
3 |
1 |
3 |
Bone Fragmentation
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Cartilage Injury
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Cervical Vertebral Fracture
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Chest Injury
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Clavicle Fracture
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
3 |
1 |
0 |
Concussion
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Contrast Media Reaction
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
1 / 93 (1.08%) |
4 / 540 (0.74%) |
occurrences all number
|
4 |
1 |
7 |
Contusion
|
|
|
|
subjects affected / exposed
|
81 / 542 (14.94%) |
6 / 93 (6.45%) |
49 / 540 (9.07%) |
occurrences all number
|
116 |
10 |
72 |
Corneal Abrasion
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Cystitis Radiation
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Device Breakage
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Excoriation
|
|
|
|
subjects affected / exposed
|
15 / 542 (2.77%) |
2 / 93 (2.15%) |
11 / 540 (2.04%) |
occurrences all number
|
20 |
3 |
12 |
Eye Injury
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Eye Penetration
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Face Injury
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Facial Bones Fracture
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Fall
|
|
|
|
subjects affected / exposed
|
47 / 542 (8.67%) |
12 / 93 (12.90%) |
20 / 540 (3.70%) |
occurrences all number
|
60 |
13 |
29 |
Fibula Fracture
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
0 |
0 |
2 |
Foot Fracture
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
1 / 93 (1.08%) |
3 / 540 (0.56%) |
occurrences all number
|
2 |
1 |
3 |
Foreign Body in Eye
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Fracture
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Gastroenteritis Radiation
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
3 |
0 |
2 |
Hand Fracture
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
1 |
0 |
Head Injury
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
1 / 93 (1.08%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
1 |
1 |
Hip Fracture
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Humerus Fracture
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
2 |
0 |
1 |
Iliotibial Band Syndrome
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Incisional Hernia
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Injury
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Joint Dislocation
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
4 |
0 |
1 |
Joint Injury
|
|
|
|
subjects affected / exposed
|
7 / 542 (1.29%) |
4 / 93 (4.30%) |
3 / 540 (0.56%) |
occurrences all number
|
7 |
4 |
4 |
Joint Sprain
|
|
|
|
subjects affected / exposed
|
12 / 542 (2.21%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
13 |
0 |
3 |
Laceration
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
3 |
0 |
1 |
Ligament Injury
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Ligament Rupture
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Limb Injury
|
|
|
|
subjects affected / exposed
|
8 / 542 (1.48%) |
1 / 93 (1.08%) |
2 / 540 (0.37%) |
occurrences all number
|
8 |
1 |
2 |
Lumbar Vertebral Fracture
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
1 |
0 |
Meniscus Lesion
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Mouth Injury
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Muscle Injury
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Muscle Rupture
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Muscle Strain
|
|
|
|
subjects affected / exposed
|
7 / 542 (1.29%) |
2 / 93 (2.15%) |
3 / 540 (0.56%) |
occurrences all number
|
7 |
2 |
3 |
Neck Injury
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Open Wound
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
0 |
0 |
3 |
Patella Fracture
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Pelvic Fracture
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
1 |
0 |
2 |
Periorbital Haematoma
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
1 |
0 |
2 |
Post Procedural Complication
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
0 |
0 |
3 |
Post Procedural Discharge
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Post Procedural Discomfort
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Post Procedural Haematuria
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Post-Traumatic Pain
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
0 |
0 |
2 |
Procedural Pain
|
|
|
|
subjects affected / exposed
|
9 / 542 (1.66%) |
0 / 93 (0.00%) |
7 / 540 (1.30%) |
occurrences all number
|
11 |
0 |
7 |
Radiation Injury
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Radiation Skin Injury
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Radius Fracture
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Rib Fracture
|
|
|
|
subjects affected / exposed
|
20 / 542 (3.69%) |
2 / 93 (2.15%) |
20 / 540 (3.70%) |
occurrences all number
|
26 |
3 |
24 |
Scapula Fracture
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Scratch
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Seroma
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Skeletal Injury
|
|
|
|
subjects affected / exposed
|
11 / 542 (2.03%) |
2 / 93 (2.15%) |
9 / 540 (1.67%) |
occurrences all number
|
12 |
2 |
9 |
Skin Injury
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Skin Laceration
|
|
|
|
subjects affected / exposed
|
13 / 542 (2.40%) |
6 / 93 (6.45%) |
15 / 540 (2.78%) |
occurrences all number
|
24 |
10 |
21 |
Soft Tissue Injury
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Spinal Compression Fracture
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
1 / 93 (1.08%) |
3 / 540 (0.56%) |
occurrences all number
|
5 |
1 |
3 |
Spinal Fracture
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Stent Occlusion
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Stress Fracture
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Subdural Haematoma
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Tendon Injury
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Tendon Rupture
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
3 |
0 |
0 |
Thoracic Vertebral Fracture
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
1 |
0 |
4 |
Tibia Fracture
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Tooth Fracture
|
|
|
|
subjects affected / exposed
|
6 / 542 (1.11%) |
0 / 93 (0.00%) |
4 / 540 (0.74%) |
occurrences all number
|
8 |
0 |
5 |
Traumatic Haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Upper Limb Fracture
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
1 |
1 |
Wound
|
|
|
|
subjects affected / exposed
|
11 / 542 (2.03%) |
1 / 93 (1.08%) |
7 / 540 (1.30%) |
occurrences all number
|
15 |
1 |
7 |
Wound Complication
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
2 |
Wrist Fracture
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
3 |
0 |
0 |
Congenital, familial and genetic disorders
|
|
|
|
Cryptorchism
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Phimosis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Cardiac disorders
|
|
|
|
Angina Pectoris
|
|
|
|
subjects affected / exposed
|
12 / 542 (2.21%) |
0 / 93 (0.00%) |
9 / 540 (1.67%) |
occurrences all number
|
12 |
0 |
11 |
Angina Unstable
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
1 |
0 |
2 |
Aortic Valve Disease
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Aortic Valve Incompetence
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Arrhythmia
|
|
|
|
subjects affected / exposed
|
7 / 542 (1.29%) |
0 / 93 (0.00%) |
4 / 540 (0.74%) |
occurrences all number
|
8 |
0 |
4 |
Arrhythmia Supraventricular
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Arteriosclerosis Coronary Artery
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Atrial Fibrillation
|
|
|
|
subjects affected / exposed
|
24 / 542 (4.43%) |
3 / 93 (3.23%) |
22 / 540 (4.07%) |
occurrences all number
|
30 |
6 |
27 |
Atrial Flutter
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
2 |
0 |
2 |
Atrial Tachycardia
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Atrioventricular Block First Degree
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Bradycardia
|
|
|
|
subjects affected / exposed
|
5 / 542 (0.92%) |
0 / 93 (0.00%) |
4 / 540 (0.74%) |
occurrences all number
|
5 |
0 |
4 |
Bundle Branch Block Left
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Bundle Branch Block Right
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
3 |
0 |
1 |
Cardiac Disorder
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Cardiac Failure
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
4 |
0 |
0 |
Cardiac Failure Acute
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Cardiac Failure Congestive
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
7 |
0 |
1 |
Cardiac Flutter
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
1 |
0 |
2 |
Cardiac Hypertrophy
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Cardiomegaly
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Cardiovascular Disorder
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Chest Discomfort
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Chest Pain
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Conduction Disorder
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Extrasystoles
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
4 / 540 (0.74%) |
occurrences all number
|
3 |
0 |
4 |
Coronary Artery Disease
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
2 |
0 |
1 |
Hypertrophic Cardiomyopathy
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Ischaemic Cardiomyopathy
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Left Ventricular Dysfunction
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Left Ventricular Hypertrophy
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Mitral Valve Disease
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Mitral Valve Incompetence
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Myocardial Infarction
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Myocardial Ischaemia
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
6 / 540 (1.11%) |
occurrences all number
|
2 |
0 |
7 |
Palpitations
|
|
|
|
subjects affected / exposed
|
14 / 542 (2.58%) |
0 / 93 (0.00%) |
9 / 540 (1.67%) |
occurrences all number
|
15 |
0 |
12 |
Right Ventricular Failure
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Sick Sinus Syndrome
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Sinus Arrhythmia
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Sinus Bradycardia
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
5 |
0 |
3 |
Sinus Tachycardia
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
4 |
0 |
2 |
Supraventricular Tachycardia
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
1 / 93 (1.08%) |
1 / 540 (0.19%) |
occurrences all number
|
4 |
1 |
1 |
Tachyarrhythmia
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Tachycardia
|
|
|
|
subjects affected / exposed
|
14 / 542 (2.58%) |
2 / 93 (2.15%) |
9 / 540 (1.67%) |
occurrences all number
|
15 |
2 |
11 |
Tricuspid Valve Incompetence
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Ventricular Extrasystoles
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
4 |
0 |
3 |
Wandering Pacemaker
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Nervous system disorders
|
|
|
|
Akathisia
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
2 |
Amnesia
|
|
|
|
subjects affected / exposed
|
6 / 542 (1.11%) |
1 / 93 (1.08%) |
3 / 540 (0.56%) |
occurrences all number
|
7 |
1 |
3 |
Aphasia
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
1 |
0 |
4 |
Aphonia
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Ataxia
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
0 |
0 |
2 |
Balance Disorder
|
|
|
|
subjects affected / exposed
|
5 / 542 (0.92%) |
1 / 93 (1.08%) |
11 / 540 (2.04%) |
occurrences all number
|
5 |
1 |
13 |
Bradykinesia
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Brain Injury
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Burning Sensation
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
7 |
0 |
2 |
Carotid Arteriosclerosis
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Carpal Tunnel Syndrome
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Cerebral Atrophy
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Cerebral Ischaemia
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
1 |
0 |
2 |
Cerebral Microangiopathy
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Cerebrovascular Accident
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
0 |
0 |
3 |
Cluster Headache
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Cognitive Disorder
|
|
|
|
subjects affected / exposed
|
5 / 542 (0.92%) |
1 / 93 (1.08%) |
3 / 540 (0.56%) |
occurrences all number
|
7 |
1 |
4 |
Convulsion
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
1 / 93 (1.08%) |
1 / 540 (0.19%) |
occurrences all number
|
2 |
3 |
1 |
Coordination Abnormal
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Dementia Alzheimer's Type
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Diabetic Autonomic Neuropathy
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Diabetic Neuropathy
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Disturbance in Attention
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Dizziness
|
|
|
|
subjects affected / exposed
|
81 / 542 (14.94%) |
7 / 93 (7.53%) |
73 / 540 (13.52%) |
occurrences all number
|
116 |
9 |
95 |
Dizziness Postural
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
5 / 540 (0.93%) |
occurrences all number
|
3 |
0 |
6 |
Drooling
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Dysaesthesia
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Dysarthria
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
1 |
0 |
2 |
Dysgeusia
|
|
|
|
subjects affected / exposed
|
19 / 542 (3.51%) |
1 / 93 (1.08%) |
15 / 540 (2.78%) |
occurrences all number
|
19 |
1 |
15 |
Dyskinesia
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Dysphasia
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Encephalopathy
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Epidural Lipomatosis
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Epiduritis
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Epilepsy
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Extrapyramidal Disorder
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Facial Neuralgia
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Facial Paresis
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Global Amnesia
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Head Discomfort
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Headache
|
|
|
|
subjects affected / exposed
|
86 / 542 (15.87%) |
9 / 93 (9.68%) |
66 / 540 (12.22%) |
occurrences all number
|
129 |
9 |
87 |
Hydrocephalus
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Hyperaesthesia
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
1 |
0 |
3 |
Hypoaesthesia
|
|
|
|
subjects affected / exposed
|
18 / 542 (3.32%) |
0 / 93 (0.00%) |
12 / 540 (2.22%) |
occurrences all number
|
22 |
0 |
15 |
Hypoaesthesia Facial
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
3 |
0 |
1 |
Hypogeusia
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Hypoglossal Nerve Disorder
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Hyposmia
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Iiird Nerve Paralysis
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Loss of Consciousness
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
3 |
0 |
0 |
Memory Impairment
|
|
|
|
subjects affected / exposed
|
6 / 542 (1.11%) |
1 / 93 (1.08%) |
9 / 540 (1.67%) |
occurrences all number
|
7 |
1 |
9 |
Migraine
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
3 |
0 |
2 |
Migraine with Aura
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Monoplegia
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Motor Dysfunction
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Myoclonus
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Nerve Compression
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Neuralgia
|
|
|
|
subjects affected / exposed
|
7 / 542 (1.29%) |
2 / 93 (2.15%) |
3 / 540 (0.56%) |
occurrences all number
|
8 |
3 |
3 |
Neuropathy Peripheral
|
|
|
|
subjects affected / exposed
|
12 / 542 (2.21%) |
7 / 93 (7.53%) |
6 / 540 (1.11%) |
occurrences all number
|
23 |
7 |
6 |
Nystagmus
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Paraesthesia
|
|
|
|
subjects affected / exposed
|
25 / 542 (4.61%) |
1 / 93 (1.08%) |
17 / 540 (3.15%) |
occurrences all number
|
33 |
2 |
18 |
Parkinson's Disease
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Parosmia
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Peripheral Motor Neuropathy
|
|
|
|
subjects affected / exposed
|
6 / 542 (1.11%) |
2 / 93 (2.15%) |
1 / 540 (0.19%) |
occurrences all number
|
8 |
2 |
1 |
Peripheral Sensory Neuropathy
|
|
|
|
subjects affected / exposed
|
13 / 542 (2.40%) |
0 / 93 (0.00%) |
13 / 540 (2.41%) |
occurrences all number
|
24 |
0 |
17 |
Peroneal Nerve Palsy
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Polyneuropathy
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
0 |
0 |
2 |
Poor Quality Sleep
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Post Herpetic Neuralgia
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
2 |
0 |
1 |
Presyncope
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
3 |
0 |
0 |
Radiculopathy
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
0 |
0 |
2 |
Reflexes Abnormal
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Restless Legs Syndrome
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
1 / 93 (1.08%) |
1 / 540 (0.19%) |
occurrences all number
|
4 |
2 |
1 |
Sciatica
|
|
|
|
subjects affected / exposed
|
11 / 542 (2.03%) |
1 / 93 (1.08%) |
10 / 540 (1.85%) |
occurrences all number
|
13 |
2 |
14 |
Sensory Disturbance
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Sinus Headache
|
|
|
|
subjects affected / exposed
|
6 / 542 (1.11%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
8 |
0 |
1 |
Somnolence
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
1 / 93 (1.08%) |
4 / 540 (0.74%) |
occurrences all number
|
4 |
1 |
5 |
Speech Disorder Developmental
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Spinal Cord Compression
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
3 |
0 |
3 |
Syncope
|
|
|
|
subjects affected / exposed
|
9 / 542 (1.66%) |
3 / 93 (3.23%) |
7 / 540 (1.30%) |
occurrences all number
|
9 |
3 |
7 |
Syncope Vasovagal
|
|
|
|
subjects affected / exposed
|
5 / 542 (0.92%) |
2 / 93 (2.15%) |
2 / 540 (0.37%) |
occurrences all number
|
5 |
2 |
2 |
Transient Ischaemic Attack
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Tremor
|
|
|
|
subjects affected / exposed
|
10 / 542 (1.85%) |
3 / 93 (3.23%) |
6 / 540 (1.11%) |
occurrences all number
|
11 |
3 |
6 |
Blood and lymphatic system disorders
|
|
|
|
Anaemia
|
|
|
|
subjects affected / exposed
|
59 / 542 (10.89%) |
12 / 93 (12.90%) |
53 / 540 (9.81%) |
occurrences all number
|
112 |
17 |
84 |
Anaemia of Malignant Disease
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Disseminated Intravascular Coagulation
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Haemorrhagic Anaemia
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Iron Deficiency Anaemia
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
3 |
0 |
0 |
Haemorrhagic Diathesis
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Leukocytosis
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Leukopenia
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Lymphadenopathy
|
|
|
|
subjects affected / exposed
|
8 / 542 (1.48%) |
0 / 93 (0.00%) |
5 / 540 (0.93%) |
occurrences all number
|
9 |
0 |
7 |
Lymphatic Obstruction
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Lymphopenia
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
3 / 93 (3.23%) |
5 / 540 (0.93%) |
occurrences all number
|
4 |
3 |
9 |
Neutropenia
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
4 / 540 (0.74%) |
occurrences all number
|
5 |
0 |
5 |
Normochromic Normocytic Anaemia
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Pernicious Anaemia
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Splenic Granuloma
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
2 |
Thrombocythaemia
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Thrombocytopenia
|
|
|
|
subjects affected / exposed
|
10 / 542 (1.85%) |
0 / 93 (0.00%) |
7 / 540 (1.30%) |
occurrences all number
|
26 |
0 |
13 |
Ear and labyrinth disorders
|
|
|
|
Cerumen Impaction
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
2 |
Conductive Deafness
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Deafness
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Ear Congestion
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
3 |
0 |
0 |
Ear Discomfort
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
2 |
0 |
1 |
Ear Pain
|
|
|
|
subjects affected / exposed
|
8 / 542 (1.48%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
11 |
0 |
1 |
Eustachian Tube Dysfunction
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Hearing Impaired
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Hyperacusis
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Hypoacusis
|
|
|
|
subjects affected / exposed
|
11 / 542 (2.03%) |
0 / 93 (0.00%) |
7 / 540 (1.30%) |
occurrences all number
|
11 |
0 |
8 |
Middle Ear Effusion
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Tinnitus
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
0 / 93 (0.00%) |
8 / 540 (1.48%) |
occurrences all number
|
4 |
0 |
8 |
Tympanic Membrane Disorder
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Tympanic Membrane Perforation
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Vertigo
|
|
|
|
subjects affected / exposed
|
17 / 542 (3.14%) |
1 / 93 (1.08%) |
5 / 540 (0.93%) |
occurrences all number
|
22 |
1 |
5 |
Eye disorders
|
|
|
|
Abnormal Sensation in Eye
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
3 |
0 |
0 |
Asthenopia
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Astigmatism
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Blepharitis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
1 |
0 |
Blepharospasm
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Blindness Transient
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Blindness Unilateral
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Borderline Glaucoma
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Cataract
|
|
|
|
subjects affected / exposed
|
13 / 542 (2.40%) |
4 / 93 (4.30%) |
12 / 540 (2.22%) |
occurrences all number
|
18 |
5 |
14 |
Conjunctival Haemorrhage
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
3 |
0 |
1 |
Conjunctivitis
|
|
|
|
subjects affected / exposed
|
7 / 542 (1.29%) |
1 / 93 (1.08%) |
3 / 540 (0.56%) |
occurrences all number
|
8 |
1 |
3 |
Conjunctivitis Allergic
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Corneal Deposits
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Diplopia
|
|
|
|
subjects affected / exposed
|
7 / 542 (1.29%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
7 |
0 |
3 |
Dry Eye
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
4 |
0 |
4 |
Episcleritis
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Erythema of Eyelid
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Exophthalmos
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Eye Discharge
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Eye Disorder
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Eye Haemorrhage
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
1 / 93 (1.08%) |
2 / 540 (0.37%) |
occurrences all number
|
3 |
1 |
2 |
Eye Inflammation
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
2 |
Eye Pain
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
3 / 93 (3.23%) |
3 / 540 (0.56%) |
occurrences all number
|
3 |
3 |
3 |
Eye Swelling
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Eyelid Irritation
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Eyelid Oedema
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Eyelid Ptosis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Glaucoma
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
2 |
0 |
2 |
Keratoconjunctivitis Sicca
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Lacrimation Increased
|
|
|
|
subjects affected / exposed
|
5 / 542 (0.92%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
7 |
0 |
3 |
Macular Degeneration
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Mydriasis
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Ocular Discomfort
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
3 |
0 |
1 |
Ocular Hyperaemia
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
1 / 93 (1.08%) |
3 / 540 (0.56%) |
occurrences all number
|
4 |
1 |
6 |
Ocular Icterus
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Ocular Surface Disease
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Orbital Oedema
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Panophthalmitis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Photophobia
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Photopsia
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Retinal Artery Occlusion
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Retinal Detachment
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Retinal Vein Thrombosis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Vision Blurred
|
|
|
|
subjects affected / exposed
|
11 / 542 (2.03%) |
0 / 93 (0.00%) |
9 / 540 (1.67%) |
occurrences all number
|
11 |
0 |
9 |
Visual Acuity Reduced
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
1 |
0 |
3 |
Visual Disturbance
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
4 / 540 (0.74%) |
occurrences all number
|
4 |
0 |
4 |
Vitreous Floaters
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
3 |
0 |
1 |
Gastrointestinal disorders
|
|
|
|
Abdominal Discomfort
|
|
|
|
subjects affected / exposed
|
12 / 542 (2.21%) |
0 / 93 (0.00%) |
9 / 540 (1.67%) |
occurrences all number
|
14 |
0 |
9 |
Abdominal Distension
|
|
|
|
subjects affected / exposed
|
15 / 542 (2.77%) |
1 / 93 (1.08%) |
11 / 540 (2.04%) |
occurrences all number
|
15 |
1 |
12 |
Abdominal Hernia
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
4 |
0 |
1 |
Abdominal Mass
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Abdominal Pain
|
|
|
|
subjects affected / exposed
|
49 / 542 (9.04%) |
5 / 93 (5.38%) |
44 / 540 (8.15%) |
occurrences all number
|
66 |
7 |
57 |
Abdominal Pain Lower
|
|
|
|
subjects affected / exposed
|
13 / 542 (2.40%) |
0 / 93 (0.00%) |
7 / 540 (1.30%) |
occurrences all number
|
16 |
0 |
8 |
Abdominal Pain Upper
|
|
|
|
subjects affected / exposed
|
19 / 542 (3.51%) |
0 / 93 (0.00%) |
20 / 540 (3.70%) |
occurrences all number
|
21 |
0 |
24 |
Abdominal Tenderness
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
2 |
0 |
1 |
Abdominal Wall Mass
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Anal Fistula
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Anal Haemorrhage
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
2 |
0 |
2 |
Anal Pruritus
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Anorectal Discomfort
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
2 |
0 |
3 |
Ascites
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
2 |
0 |
1 |
Barrett's Oesophagus
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Bowel Movement Irregularity
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Breath Odour
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Change of Bowel Habit
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Cheilitis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
1 |
0 |
3 |
Colitis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
4 |
Colitis Ischaemic
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Colonic Polyp
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
1 / 93 (1.08%) |
1 / 540 (0.19%) |
occurrences all number
|
2 |
1 |
1 |
Constipation
|
|
|
|
subjects affected / exposed
|
144 / 542 (26.57%) |
15 / 93 (16.13%) |
112 / 540 (20.74%) |
occurrences all number
|
204 |
16 |
140 |
Defaecation Urgency
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
7 |
0 |
1 |
Dental Caries
|
|
|
|
subjects affected / exposed
|
6 / 542 (1.11%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
6 |
0 |
0 |
Dental Discomfort
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Diarrhoea
|
|
|
|
subjects affected / exposed
|
135 / 542 (24.91%) |
13 / 93 (13.98%) |
98 / 540 (18.15%) |
occurrences all number
|
203 |
16 |
142 |
Diverticulum
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
2 |
0 |
2 |
Diverticulum Intestinal
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
3 |
1 |
0 |
Dry Mouth
|
|
|
|
subjects affected / exposed
|
20 / 542 (3.69%) |
2 / 93 (2.15%) |
16 / 540 (2.96%) |
occurrences all number
|
26 |
2 |
16 |
Duodenal Ulcer
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Dyspepsia
|
|
|
|
subjects affected / exposed
|
62 / 542 (11.44%) |
1 / 93 (1.08%) |
28 / 540 (5.19%) |
occurrences all number
|
78 |
1 |
29 |
Dysphagia
|
|
|
|
subjects affected / exposed
|
5 / 542 (0.92%) |
2 / 93 (2.15%) |
11 / 540 (2.04%) |
occurrences all number
|
5 |
2 |
14 |
Enteritis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Enterovesical Fistula
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Epigastric Discomfort
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
3 / 540 (0.56%) |
occurrences all number
|
0 |
1 |
3 |
Eructation
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
3 |
0 |
3 |
Faecal Incontinence
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
4 |
0 |
2 |
Faeces Discoloured
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
3 |
0 |
1 |
Flatulence
|
|
|
|
subjects affected / exposed
|
23 / 542 (4.24%) |
1 / 93 (1.08%) |
11 / 540 (2.04%) |
occurrences all number
|
25 |
1 |
12 |
Food Poisoning
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
1 / 93 (1.08%) |
2 / 540 (0.37%) |
occurrences all number
|
2 |
1 |
2 |
Frequent Bowel Movements
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Gastric Disorder
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Gastric Ulcer
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Gastritis
|
|
|
|
subjects affected / exposed
|
8 / 542 (1.48%) |
2 / 93 (2.15%) |
5 / 540 (0.93%) |
occurrences all number
|
8 |
2 |
5 |
Gastritis Atrophic
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Gastritis Haemorrhagic
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Gastrointestinal Angiodysplasia
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Gastrointestinal Disorder
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Gastrointestinal Haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Gastrointestinal Motility Disorder
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Gastrooesophageal Reflux Disease
|
|
|
|
subjects affected / exposed
|
27 / 542 (4.98%) |
1 / 93 (1.08%) |
24 / 540 (4.44%) |
occurrences all number
|
33 |
1 |
26 |
Gingival Pain
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
1 / 93 (1.08%) |
1 / 540 (0.19%) |
occurrences all number
|
3 |
1 |
1 |
Gingivitis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Glossodynia
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Haematemesis
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Haematochezia
|
|
|
|
subjects affected / exposed
|
7 / 542 (1.29%) |
2 / 93 (2.15%) |
7 / 540 (1.30%) |
occurrences all number
|
9 |
2 |
7 |
Haemorrhoidal Haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Haemorrhoids
|
|
|
|
subjects affected / exposed
|
9 / 542 (1.66%) |
1 / 93 (1.08%) |
7 / 540 (1.30%) |
occurrences all number
|
12 |
1 |
7 |
Hiatus Hernia
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
1 / 93 (1.08%) |
1 / 540 (0.19%) |
occurrences all number
|
2 |
1 |
1 |
Hypoaesthesia Oral
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Ileus
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Inflammatory Bowel Disease
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Inguinal Hernia
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Intestinal Haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Intra-Abdominal Haematoma
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
1 |
0 |
2 |
Lip Dry
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Lip Swelling
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
0 |
0 |
2 |
Lip Ulceration
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Loose Tooth
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
2 |
0 |
2 |
Malocclusion
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Melaena
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
3 |
0 |
1 |
Mesenteric Vein Thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Mouth Ulceration
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
4 |
0 |
2 |
Nausea
|
|
|
|
subjects affected / exposed
|
144 / 542 (26.57%) |
15 / 93 (16.13%) |
127 / 540 (23.52%) |
occurrences all number
|
210 |
17 |
155 |
Odynophagia
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
2 |
0 |
1 |
Oedema Mouth
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Oesophageal Disorder
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Oesophageal Pain
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
0 |
0 |
2 |
Oesophagitis
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
2 |
0 |
2 |
Oral Disorder
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Oral Pain
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Oral Pruritus
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Oroantral Fistula
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Painful Defaecation
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Pancreatic Cyst
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Pancreatic Insufficiency
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Paraesthesia Oral
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Peptic Ulcer
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Periodontal Disease
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Peritonitis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Pigmentation Buccal
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Proctalgia
|
|
|
|
subjects affected / exposed
|
7 / 542 (1.29%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
7 |
0 |
2 |
Proctitis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
1 / 93 (1.08%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
1 |
1 |
Rectal Haemorrhage
|
|
|
|
subjects affected / exposed
|
21 / 542 (3.87%) |
1 / 93 (1.08%) |
11 / 540 (2.04%) |
occurrences all number
|
24 |
1 |
12 |
Rectal Polyp
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Rectal Spasm
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Reflux Oesophagitis
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
2 |
0 |
1 |
Retching
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
2 |
0 |
2 |
Salivary Hypersecretion
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Sensitivity of Teeth
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
3 |
0 |
0 |
Small Intestinal Haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Stomach Discomfort
|
|
|
|
subjects affected / exposed
|
7 / 542 (1.29%) |
0 / 93 (0.00%) |
7 / 540 (1.30%) |
occurrences all number
|
7 |
0 |
7 |
Stomatitis
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
2 |
0 |
2 |
Tongue Black Hairy
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Tongue Coated
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
3 |
0 |
1 |
Tongue Ulceration
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Tooth Disorder
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Toothache
|
|
|
|
subjects affected / exposed
|
15 / 542 (2.77%) |
2 / 93 (2.15%) |
11 / 540 (2.04%) |
occurrences all number
|
18 |
2 |
13 |
Vomiting
|
|
|
|
subjects affected / exposed
|
86 / 542 (15.87%) |
12 / 93 (12.90%) |
61 / 540 (11.30%) |
occurrences all number
|
115 |
14 |
76 |
Hepatobiliary disorders
|
|
|
|
Cholelithiasis
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
3 |
0 |
2 |
Hepatomegaly
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
1 |
1 |
Hepatotoxicity
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
3 |
0 |
0 |
Hyperbilirubinaemia
|
|
|
|
subjects affected / exposed
|
13 / 542 (2.40%) |
1 / 93 (1.08%) |
8 / 540 (1.48%) |
occurrences all number
|
26 |
1 |
13 |
Jaundice
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
3 |
0 |
0 |
Jaundice Cholestatic
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Skin and subcutaneous tissue disorders
|
|
|
|
Acne
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Actinic Keratosis
|
|
|
|
subjects affected / exposed
|
8 / 542 (1.48%) |
0 / 93 (0.00%) |
4 / 540 (0.74%) |
occurrences all number
|
10 |
0 |
12 |
Alopecia
|
|
|
|
subjects affected / exposed
|
13 / 542 (2.40%) |
2 / 93 (2.15%) |
9 / 540 (1.67%) |
occurrences all number
|
14 |
2 |
9 |
Angioedema
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Blister
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Blood Blister
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Campbell De Morgan Spots
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Cold Sweat
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Decubitus Ulcer
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
1 |
1 |
Dermal Cyst
|
|
|
|
subjects affected / exposed
|
6 / 542 (1.11%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
6 |
0 |
1 |
Dermatitis
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
4 / 540 (0.74%) |
occurrences all number
|
0 |
0 |
4 |
Dermatitis Acneiform
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
2 |
0 |
1 |
Dermatitis Allergic
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Dermatitis Contact
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
1 |
0 |
2 |
Dry Skin
|
|
|
|
subjects affected / exposed
|
12 / 542 (2.21%) |
4 / 93 (4.30%) |
13 / 540 (2.41%) |
occurrences all number
|
13 |
4 |
18 |
Ecchymosis
|
|
|
|
subjects affected / exposed
|
25 / 542 (4.61%) |
1 / 93 (1.08%) |
19 / 540 (3.52%) |
occurrences all number
|
32 |
1 |
26 |
Eczema
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
4 |
0 |
3 |
Erythema
|
|
|
|
subjects affected / exposed
|
16 / 542 (2.95%) |
2 / 93 (2.15%) |
9 / 540 (1.67%) |
occurrences all number
|
17 |
3 |
9 |
Facial Wasting
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Haemorrhage Subcutaneous
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Hair Growth Abnormal
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
3 |
0 |
2 |
Hyperhidrosis
|
|
|
|
subjects affected / exposed
|
20 / 542 (3.69%) |
0 / 93 (0.00%) |
21 / 540 (3.89%) |
occurrences all number
|
26 |
0 |
27 |
Hyperkeratosis
|
|
|
|
subjects affected / exposed
|
5 / 542 (0.92%) |
1 / 93 (1.08%) |
1 / 540 (0.19%) |
occurrences all number
|
5 |
2 |
1 |
Hypertrichosis
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Hypoaesthesia Facial
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Increased Tendency to Bruise
|
|
|
|
subjects affected / exposed
|
22 / 542 (4.06%) |
0 / 93 (0.00%) |
14 / 540 (2.59%) |
occurrences all number
|
23 |
0 |
16 |
Ingrowing Nail
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
3 |
0 |
1 |
Keloid Scar
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Lentigo
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Lipohypertrophy
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Livedo Reticularis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Nail Disorder
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
1 |
0 |
2 |
Neurodermatitis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
2 |
Night Sweats
|
|
|
|
subjects affected / exposed
|
13 / 542 (2.40%) |
2 / 93 (2.15%) |
10 / 540 (1.85%) |
occurrences all number
|
14 |
3 |
13 |
Onychalgia
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Onychoclasis
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
0 |
0 |
2 |
Onychomadesis
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Pain of Skin
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Palmar-Plantar Erythrodysaesthesia Syndrome
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
2 |
Periorbital Oedema
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
4 |
0 |
3 |
Petechiae
|
|
|
|
subjects affected / exposed
|
5 / 542 (0.92%) |
0 / 93 (0.00%) |
4 / 540 (0.74%) |
occurrences all number
|
5 |
0 |
4 |
Photosensitivity Reaction
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Pigmentation Disorder
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Pityriasis Rosea
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Precancerous Skin Lesion
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Pruritus
|
|
|
|
subjects affected / exposed
|
17 / 542 (3.14%) |
0 / 93 (0.00%) |
10 / 540 (1.85%) |
occurrences all number
|
19 |
0 |
11 |
Pruritus Generalised
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
3 |
0 |
0 |
Psoriasis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Purpura
|
|
|
|
subjects affected / exposed
|
6 / 542 (1.11%) |
1 / 93 (1.08%) |
4 / 540 (0.74%) |
occurrences all number
|
6 |
1 |
5 |
Purpura Senile
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Rash
|
|
|
|
subjects affected / exposed
|
49 / 542 (9.04%) |
1 / 93 (1.08%) |
21 / 540 (3.89%) |
occurrences all number
|
64 |
1 |
22 |
Rash Erythematous
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
1 |
0 |
2 |
Rash Follicular
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Rash Macular
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
2 |
0 |
2 |
Rash Maculo-Papular
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
4 |
0 |
0 |
Rash Papular
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Rash Pruritic
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
4 |
0 |
0 |
Rash Vesicular
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Rosacea
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Scab
|
|
|
|
subjects affected / exposed
|
6 / 542 (1.11%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
7 |
0 |
1 |
Scar
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Seborrhoeic Dermatitis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Skin Atrophy
|
|
|
|
subjects affected / exposed
|
7 / 542 (1.29%) |
0 / 93 (0.00%) |
9 / 540 (1.67%) |
occurrences all number
|
7 |
0 |
10 |
Skin Discolouration
|
|
|
|
subjects affected / exposed
|
6 / 542 (1.11%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
6 |
0 |
2 |
Skin Disorder
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
1 |
0 |
2 |
Skin Exfoliation
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
3 |
0 |
1 |
Skin Fragility
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
2 / 93 (2.15%) |
1 / 540 (0.19%) |
occurrences all number
|
2 |
2 |
1 |
Skin Haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Skin Induration
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Skin Inflammation
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Skin Irritation
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Skin Lesion
|
|
|
|
subjects affected / exposed
|
15 / 542 (2.77%) |
2 / 93 (2.15%) |
5 / 540 (0.93%) |
occurrences all number
|
18 |
2 |
6 |
Skin Mass
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Skin Nodule
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
0 |
0 |
2 |
Skin Striae
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Skin Toxicity
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Skin Ulcer
|
|
|
|
subjects affected / exposed
|
5 / 542 (0.92%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
7 |
0 |
1 |
Stasis Dermatitis
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Swelling Face
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
3 |
0 |
0 |
Telangiectasia
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
2 |
0 |
1 |
Urticaria
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
4 / 540 (0.74%) |
occurrences all number
|
3 |
0 |
4 |
Renal and urinary disorders
|
|
|
|
Anuria
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Azotaemia
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Bladder Discomfort
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Bladder Disorder
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Bladder Obstruction
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Bladder Hypertrophy
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Bladder Pain
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Bladder Stenosis
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Bladder Spasm
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
1 / 93 (1.08%) |
1 / 540 (0.19%) |
occurrences all number
|
4 |
1 |
1 |
Calculus Bladder
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Calculus Ureteric
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Calculus Urethral
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Chromaturia
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Cystitis Noninfective
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Enuresis
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
3 |
0 |
3 |
Dysuria
|
|
|
|
subjects affected / exposed
|
21 / 542 (3.87%) |
1 / 93 (1.08%) |
21 / 540 (3.89%) |
occurrences all number
|
26 |
1 |
26 |
Glycosuria
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Haematuria
|
|
|
|
subjects affected / exposed
|
56 / 542 (10.33%) |
4 / 93 (4.30%) |
32 / 540 (5.93%) |
occurrences all number
|
89 |
4 |
40 |
Haemorrhage Urinary Tract
|
|
|
|
subjects affected / exposed
|
11 / 542 (2.03%) |
0 / 93 (0.00%) |
6 / 540 (1.11%) |
occurrences all number
|
14 |
0 |
6 |
Hydronephrosis
|
|
|
|
subjects affected / exposed
|
7 / 542 (1.29%) |
2 / 93 (2.15%) |
15 / 540 (2.78%) |
occurrences all number
|
8 |
2 |
17 |
Hydroureter
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
1 |
0 |
2 |
Kidney Enlargement
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Leukocyturia
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Micturition Urgency
|
|
|
|
subjects affected / exposed
|
11 / 542 (2.03%) |
1 / 93 (1.08%) |
12 / 540 (2.22%) |
occurrences all number
|
12 |
1 |
12 |
Nephrolithiasis
|
|
|
|
subjects affected / exposed
|
5 / 542 (0.92%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
6 |
0 |
3 |
Nocturia
|
|
|
|
subjects affected / exposed
|
38 / 542 (7.01%) |
0 / 93 (0.00%) |
29 / 540 (5.37%) |
occurrences all number
|
45 |
0 |
34 |
Obstructive Uropathy
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Oliguria
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
0 |
0 |
2 |
Pollakiuria
|
|
|
|
subjects affected / exposed
|
56 / 542 (10.33%) |
2 / 93 (2.15%) |
55 / 540 (10.19%) |
occurrences all number
|
85 |
2 |
70 |
Polyuria
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
1 / 93 (1.08%) |
3 / 540 (0.56%) |
occurrences all number
|
4 |
1 |
3 |
Proteinuria
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
2 |
0 |
1 |
Pyelocaliectasis
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Renal Colic
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
2 |
0 |
1 |
Renal Failure
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
1 / 93 (1.08%) |
3 / 540 (0.56%) |
occurrences all number
|
3 |
1 |
3 |
Renal Failure Acute
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
0 / 93 (0.00%) |
5 / 540 (0.93%) |
occurrences all number
|
4 |
0 |
5 |
Renal Failure Chronic
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
3 |
0 |
1 |
Renal Impairment
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
3 |
0 |
3 |
Renal Mass
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Renal Pain
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
0 |
0 |
2 |
Stress Urinary Incontinence
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
1 / 93 (1.08%) |
2 / 540 (0.37%) |
occurrences all number
|
3 |
1 |
2 |
Ureteric Obstruction
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
2 |
0 |
3 |
Ureteric Stenosis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Urethral Haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Urethral Obstruction
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
2 |
0 |
1 |
Urethral Pain
|
|
|
|
subjects affected / exposed
|
5 / 542 (0.92%) |
1 / 93 (1.08%) |
2 / 540 (0.37%) |
occurrences all number
|
6 |
1 |
5 |
Urethral Stenosis
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
4 |
0 |
0 |
Urge Incontinence
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Urinary Bladder Haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Urinary Hesitation
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
3 |
1 |
0 |
Urinary Incontinence
|
|
|
|
subjects affected / exposed
|
37 / 542 (6.83%) |
0 / 93 (0.00%) |
25 / 540 (4.63%) |
occurrences all number
|
49 |
0 |
37 |
Urinary Retention
|
|
|
|
subjects affected / exposed
|
18 / 542 (3.32%) |
1 / 93 (1.08%) |
14 / 540 (2.59%) |
occurrences all number
|
24 |
1 |
16 |
Urinary Tract Disorder
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Urinary Tract Inflammation
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Urinary Tract Obstruction
|
|
|
|
subjects affected / exposed
|
6 / 542 (1.11%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
8 |
0 |
1 |
Urinary Tract Pain
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Urine Abnormality
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Urine Flow Decreased
|
|
|
|
subjects affected / exposed
|
8 / 542 (1.48%) |
0 / 93 (0.00%) |
8 / 540 (1.48%) |
occurrences all number
|
8 |
0 |
8 |
Urine Odour Abnormal
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Urogenital Haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Endocrine disorders
|
|
|
|
Adrenal Insufficiency
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
2 |
0 |
2 |
Cushing's Syndrome
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Cushingoid
|
|
|
|
subjects affected / exposed
|
7 / 542 (1.29%) |
1 / 93 (1.08%) |
12 / 540 (2.22%) |
occurrences all number
|
8 |
1 |
13 |
Feminisation Acquired
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Gynaecomastia
|
|
|
|
subjects affected / exposed
|
14 / 542 (2.58%) |
3 / 93 (3.23%) |
21 / 540 (3.89%) |
occurrences all number
|
14 |
3 |
24 |
Hyperparathyroidism
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Hyperparathyroidism Primary
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Hyperthyroidism
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
2 |
0 |
2 |
Hypoparathyroidism
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Hypoparathyroidism Secondary
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Hypothyroidism
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
4 |
0 |
1 |
Pituitary-Dependent Cushing's Syndrome
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Primary Hyperaldosteronism
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Steroid Withdrawal Syndrome
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Musculoskeletal and connective tissue disorders
|
|
|
|
Amyotrophy
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Arthralgia
|
|
|
|
subjects affected / exposed
|
172 / 542 (31.73%) |
19 / 93 (20.43%) |
131 / 540 (24.26%) |
occurrences all number
|
302 |
29 |
195 |
Arthritis
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
4 |
0 |
2 |
Arthropathy
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Back Disorder
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Back Pain
|
|
|
|
subjects affected / exposed
|
199 / 542 (36.72%) |
26 / 93 (27.96%) |
180 / 540 (33.33%) |
occurrences all number
|
359 |
39 |
311 |
Bone Disorder
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Bone Pain
|
|
|
|
subjects affected / exposed
|
144 / 542 (26.57%) |
14 / 93 (15.05%) |
112 / 540 (20.74%) |
occurrences all number
|
229 |
16 |
159 |
Bone Swelling
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Bunion
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Bursitis
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
2 / 93 (2.15%) |
7 / 540 (1.30%) |
occurrences all number
|
5 |
2 |
7 |
Coccydynia
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
5 / 540 (0.93%) |
occurrences all number
|
2 |
0 |
5 |
Dupuytren's Contracture
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Exostosis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Flank Pain
|
|
|
|
subjects affected / exposed
|
27 / 542 (4.98%) |
1 / 93 (1.08%) |
16 / 540 (2.96%) |
occurrences all number
|
30 |
1 |
21 |
Foot Deformity
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Groin Pain
|
|
|
|
subjects affected / exposed
|
41 / 542 (7.56%) |
0 / 93 (0.00%) |
22 / 540 (4.07%) |
occurrences all number
|
52 |
0 |
33 |
Intervertebral Disc Compression
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Intervertebral Disc Protrusion
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Joint Range of Motion Decreased
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
2 |
0 |
1 |
Joint Stiffness
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
4 |
0 |
1 |
Joint Swelling
|
|
|
|
subjects affected / exposed
|
7 / 542 (1.29%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
7 |
0 |
3 |
Limb Discomfort
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
7 / 540 (1.30%) |
occurrences all number
|
2 |
0 |
7 |
Low Turnover Osteopathy
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Lumbar Spinal Stenosis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Mobility Decreased
|
|
|
|
subjects affected / exposed
|
5 / 542 (0.92%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
6 |
0 |
1 |
Muscle Atrophy
|
|
|
|
subjects affected / exposed
|
5 / 542 (0.92%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
5 |
0 |
2 |
Muscle Disorder
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Muscle Mass
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Muscle Spasms
|
|
|
|
subjects affected / exposed
|
78 / 542 (14.39%) |
2 / 93 (2.15%) |
111 / 540 (20.56%) |
occurrences all number
|
107 |
2 |
173 |
Muscle Twitching
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
1 |
0 |
3 |
Muscular Weakness
|
|
|
|
subjects affected / exposed
|
35 / 542 (6.46%) |
5 / 93 (5.38%) |
42 / 540 (7.78%) |
occurrences all number
|
55 |
6 |
52 |
Musculoskeletal Chest Pain
|
|
|
|
subjects affected / exposed
|
22 / 542 (4.06%) |
4 / 93 (4.30%) |
26 / 540 (4.81%) |
occurrences all number
|
25 |
4 |
26 |
Musculoskeletal Discomfort
|
|
|
|
subjects affected / exposed
|
12 / 542 (2.21%) |
1 / 93 (1.08%) |
13 / 540 (2.41%) |
occurrences all number
|
13 |
1 |
13 |
Musculoskeletal Disorder
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Musculoskeletal Pain
|
|
|
|
subjects affected / exposed
|
97 / 542 (17.90%) |
12 / 93 (12.90%) |
77 / 540 (14.26%) |
occurrences all number
|
144 |
13 |
106 |
Musculoskeletal Stiffness
|
|
|
|
subjects affected / exposed
|
8 / 542 (1.48%) |
0 / 93 (0.00%) |
6 / 540 (1.11%) |
occurrences all number
|
11 |
0 |
6 |
Myalgia
|
|
|
|
subjects affected / exposed
|
40 / 542 (7.38%) |
3 / 93 (3.23%) |
32 / 540 (5.93%) |
occurrences all number
|
48 |
3 |
39 |
Myopathy
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
1 / 93 (1.08%) |
3 / 540 (0.56%) |
occurrences all number
|
2 |
2 |
8 |
Myopathy Steroid
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
2 |
0 |
2 |
Myosclerosis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Myositis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Neck Mass
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
0 |
0 |
2 |
Neck Pain
|
|
|
|
subjects affected / exposed
|
30 / 542 (5.54%) |
2 / 93 (2.15%) |
17 / 540 (3.15%) |
occurrences all number
|
41 |
2 |
20 |
Nodule on Extremity
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Osteitis
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Osteoarthritis
|
|
|
|
subjects affected / exposed
|
7 / 542 (1.29%) |
1 / 93 (1.08%) |
5 / 540 (0.93%) |
occurrences all number
|
10 |
1 |
6 |
Osteonecrosis
|
|
|
|
subjects affected / exposed
|
8 / 542 (1.48%) |
1 / 93 (1.08%) |
5 / 540 (0.93%) |
occurrences all number
|
11 |
3 |
5 |
Osteopenia
|
|
|
|
subjects affected / exposed
|
5 / 542 (0.92%) |
0 / 93 (0.00%) |
4 / 540 (0.74%) |
occurrences all number
|
5 |
0 |
4 |
Osteoporosis
|
|
|
|
subjects affected / exposed
|
12 / 542 (2.21%) |
3 / 93 (3.23%) |
7 / 540 (1.30%) |
occurrences all number
|
13 |
4 |
7 |
Osteoporotic Fracture
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Pain in Extremity
|
|
|
|
subjects affected / exposed
|
107 / 542 (19.74%) |
16 / 93 (17.20%) |
89 / 540 (16.48%) |
occurrences all number
|
172 |
20 |
127 |
Pain in Jaw
|
|
|
|
subjects affected / exposed
|
15 / 542 (2.77%) |
1 / 93 (1.08%) |
7 / 540 (1.30%) |
occurrences all number
|
23 |
1 |
7 |
Pathological Fracture
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
3 |
0 |
2 |
Periarthritis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Polyarthritis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Pubic Pain
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Rotator Cuff Syndrome
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Sensation of Heaviness
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Soft Tissue Disorder
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Spinal Column Stenosis
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
0 |
0 |
2 |
Spinal Osteoarthritis
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Synovial Cyst
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
4 |
0 |
2 |
Tendon Pain
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
2 |
0 |
1 |
Tendonitis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
2 / 93 (2.15%) |
2 / 540 (0.37%) |
occurrences all number
|
1 |
2 |
2 |
Torticollis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Trigger Finger
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Upper Extremity Mass
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Vertebral Column Mass
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Infections and infestations
|
|
|
|
Abdominal Abscess
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Abdominal Wall Abscess
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Abscess Jaw
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Abscess Limb
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
1 |
1 |
Abscess Oral
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
0 |
0 |
2 |
Acute Sinusitis
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Anal Abscess
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
2 |
Arthritis Bacterial
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Arthritis Infective
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Bacterial Sepsis
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Bacteriuria
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Bronchitis
|
|
|
|
subjects affected / exposed
|
34 / 542 (6.27%) |
0 / 93 (0.00%) |
14 / 540 (2.59%) |
occurrences all number
|
39 |
0 |
16 |
Bronchitis Bacterial
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Bronchitis Viral
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Bronchopulmonary Aspergillosis
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Campylobacter Infection
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Campylobacter Intestinal Infection
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Candidiasis
|
|
|
|
subjects affected / exposed
|
6 / 542 (1.11%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
6 |
0 |
3 |
Catheter Related Infection
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Catheter Site Infection
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Cellulitis
|
|
|
|
subjects affected / exposed
|
16 / 542 (2.95%) |
4 / 93 (4.30%) |
8 / 540 (1.48%) |
occurrences all number
|
18 |
7 |
8 |
Chest Wall Abscess
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Clostridial Infection
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
0 |
0 |
2 |
Clostridium Difficile Colitis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Cystitis
|
|
|
|
subjects affected / exposed
|
8 / 542 (1.48%) |
2 / 93 (2.15%) |
5 / 540 (0.93%) |
occurrences all number
|
12 |
2 |
6 |
Diverticulitis
|
|
|
|
subjects affected / exposed
|
8 / 542 (1.48%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
9 |
0 |
4 |
Ear Infection
|
|
|
|
subjects affected / exposed
|
9 / 542 (1.66%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
10 |
0 |
0 |
Endocarditis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Escherichia Urinary Tract Infection
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
External Ear Cellulitis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Eye Infection
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
1 / 93 (1.08%) |
2 / 540 (0.37%) |
occurrences all number
|
5 |
1 |
2 |
Eyelid Infection
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
2 |
0 |
1 |
Febrile Infection
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
0 |
0 |
3 |
Folliculitis
|
|
|
|
subjects affected / exposed
|
5 / 542 (0.92%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
5 |
0 |
4 |
Fungal Infection
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
4 |
0 |
3 |
Fungal Oesophagitis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Fungal Skin Infection
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
2 |
0 |
3 |
Furuncle
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
4 |
0 |
1 |
Gastroenteritis
|
|
|
|
subjects affected / exposed
|
9 / 542 (1.66%) |
1 / 93 (1.08%) |
9 / 540 (1.67%) |
occurrences all number
|
9 |
1 |
9 |
Gastroenteritis Norovirus
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Gastroenteritis Viral
|
|
|
|
subjects affected / exposed
|
9 / 542 (1.66%) |
3 / 93 (3.23%) |
3 / 540 (0.56%) |
occurrences all number
|
9 |
4 |
3 |
Gastrointestinal Infection
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Gingival Abscess
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Gingival Infection
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
3 |
0 |
2 |
Groin Abscess
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Hepatitis C
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Herpes Simplex
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Herpes Virus Infection
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Herpes Zoster
|
|
|
|
subjects affected / exposed
|
10 / 542 (1.85%) |
2 / 93 (2.15%) |
8 / 540 (1.48%) |
occurrences all number
|
11 |
2 |
9 |
Hordeolum
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
3 |
0 |
0 |
Infected Cyst
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Infected Skin Ulcer
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Infection
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Influenza
|
|
|
|
subjects affected / exposed
|
25 / 542 (4.61%) |
3 / 93 (3.23%) |
15 / 540 (2.78%) |
occurrences all number
|
35 |
3 |
16 |
Labyrinthitis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Laryngitis
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
4 |
0 |
1 |
Lobar Pneumonia
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
3 |
0 |
1 |
Localised Infection
|
|
|
|
subjects affected / exposed
|
5 / 542 (0.92%) |
1 / 93 (1.08%) |
5 / 540 (0.93%) |
occurrences all number
|
5 |
1 |
5 |
Lower Respiratory Tract Infection
|
|
|
|
subjects affected / exposed
|
12 / 542 (2.21%) |
5 / 93 (5.38%) |
13 / 540 (2.41%) |
occurrences all number
|
17 |
8 |
16 |
Lower Respiratory Tract Infection Viral
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Lung Infection
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
3 |
0 |
3 |
Nail Infection
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Nasopharyngitis
|
|
|
|
subjects affected / exposed
|
65 / 542 (11.99%) |
5 / 93 (5.38%) |
46 / 540 (8.52%) |
occurrences all number
|
94 |
8 |
59 |
Oesophageal Candidiasis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Oesophageal Infection
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Onychomycosis
|
|
|
|
subjects affected / exposed
|
8 / 542 (1.48%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
8 |
0 |
1 |
Oral Candidiasis
|
|
|
|
subjects affected / exposed
|
12 / 542 (2.21%) |
2 / 93 (2.15%) |
10 / 540 (1.85%) |
occurrences all number
|
13 |
3 |
10 |
Oral Fungal Infection
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Oral Herpes
|
|
|
|
subjects affected / exposed
|
10 / 542 (1.85%) |
1 / 93 (1.08%) |
5 / 540 (0.93%) |
occurrences all number
|
13 |
1 |
5 |
Oral Infection
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Osteomyelitis
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Otitis Externa
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Otitis Media
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
0 |
0 |
2 |
Paronychia
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Parotitis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Pertussis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Pharyngitis
|
|
|
|
subjects affected / exposed
|
5 / 542 (0.92%) |
0 / 93 (0.00%) |
4 / 540 (0.74%) |
occurrences all number
|
5 |
0 |
4 |
Pharyngitis Streptococcal
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Pneumonia
|
|
|
|
subjects affected / exposed
|
6 / 542 (1.11%) |
1 / 93 (1.08%) |
7 / 540 (1.30%) |
occurrences all number
|
7 |
1 |
8 |
Pneumonia Klebsiella
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
2 |
Postoperative Wound Infection
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
0 |
0 |
2 |
Prostatic Abscess
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Proteus Infection
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Pyelonephritis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Rash Pustular
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
2 |
Respiratory Tract Infection
|
|
|
|
subjects affected / exposed
|
6 / 542 (1.11%) |
1 / 93 (1.08%) |
5 / 540 (0.93%) |
occurrences all number
|
6 |
1 |
5 |
Rhinitis
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
1 / 93 (1.08%) |
2 / 540 (0.37%) |
occurrences all number
|
2 |
1 |
3 |
Rotavirus Infection
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Salmonellosis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Sepsis
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
3 |
0 |
0 |
Septic Shock
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Sinusitis
|
|
|
|
subjects affected / exposed
|
29 / 542 (5.35%) |
3 / 93 (3.23%) |
5 / 540 (0.93%) |
occurrences all number
|
43 |
3 |
5 |
Skin Candida
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Skin Infection
|
|
|
|
subjects affected / exposed
|
7 / 542 (1.29%) |
1 / 93 (1.08%) |
1 / 540 (0.19%) |
occurrences all number
|
8 |
1 |
1 |
Soft Tissue Infection
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Staphylococcal Infection
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Staphylococcal Sepsis
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Streptococcal Infection
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Subcutaneous Abscess
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Tinea Cruris
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Tinea Pedis
|
|
|
|
subjects affected / exposed
|
5 / 542 (0.92%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
5 |
0 |
1 |
Tonsillitis
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Tooth Abscess
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
1 / 93 (1.08%) |
7 / 540 (1.30%) |
occurrences all number
|
4 |
1 |
8 |
Tooth Infection
|
|
|
|
subjects affected / exposed
|
13 / 542 (2.40%) |
1 / 93 (1.08%) |
3 / 540 (0.56%) |
occurrences all number
|
15 |
1 |
4 |
Tracheitis
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Upper Respiratory Tract Infection
|
|
|
|
subjects affected / exposed
|
74 / 542 (13.65%) |
4 / 93 (4.30%) |
43 / 540 (7.96%) |
occurrences all number
|
108 |
5 |
58 |
Urinary Tract Infection
|
|
|
|
subjects affected / exposed
|
49 / 542 (9.04%) |
11 / 93 (11.83%) |
40 / 540 (7.41%) |
occurrences all number
|
73 |
21 |
61 |
Urinary Tract Infection Bacterial
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Urinary Tract Infection Pseudomonal
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
1 / 93 (1.08%) |
0 / 540 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Urosepsis
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
0 |
0 |
2 |
Viral Infection
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
4 / 540 (0.74%) |
occurrences all number
|
2 |
0 |
4 |
Viral Upper Respiratory Tract Infection
|
|
|
|
subjects affected / exposed
|
8 / 542 (1.48%) |
1 / 93 (1.08%) |
1 / 540 (0.19%) |
occurrences all number
|
8 |
1 |
1 |
Wound Infection
|
|
|
|
subjects affected / exposed
|
4 / 542 (0.74%) |
1 / 93 (1.08%) |
2 / 540 (0.37%) |
occurrences all number
|
4 |
1 |
2 |
Metabolism and nutrition disorders
|
|
|
|
Anorexia
|
|
|
|
subjects affected / exposed
|
56 / 542 (10.33%) |
10 / 93 (10.75%) |
40 / 540 (7.41%) |
occurrences all number
|
75 |
11 |
46 |
Central Obesity
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Decreased Appetite
|
|
|
|
subjects affected / exposed
|
28 / 542 (5.17%) |
0 / 93 (0.00%) |
30 / 540 (5.56%) |
occurrences all number
|
31 |
0 |
31 |
Dehydration
|
|
|
|
subjects affected / exposed
|
14 / 542 (2.58%) |
4 / 93 (4.30%) |
18 / 540 (3.33%) |
occurrences all number
|
17 |
5 |
20 |
Diabetes Mellitus
|
|
|
|
subjects affected / exposed
|
12 / 542 (2.21%) |
0 / 93 (0.00%) |
8 / 540 (1.48%) |
occurrences all number
|
12 |
0 |
8 |
Diabetes Mellitus Inadequate Control
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
1 |
0 |
2 |
Dyslipidaemia
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Failure to Thrive
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
0 |
0 |
3 |
Fluid Retention
|
|
|
|
subjects affected / exposed
|
6 / 542 (1.11%) |
0 / 93 (0.00%) |
3 / 540 (0.56%) |
occurrences all number
|
6 |
0 |
3 |
Glucose Tolerance Impaired
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Gout
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
2 |
0 |
1 |
Hyperalbuminaemia
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
2 / 540 (0.37%) |
occurrences all number
|
1 |
0 |
2 |
Hypercalcaemia
|
|
|
|
subjects affected / exposed
|
9 / 542 (1.66%) |
0 / 93 (0.00%) |
6 / 540 (1.11%) |
occurrences all number
|
13 |
0 |
6 |
Hypercholesterolaemia
|
|
|
|
subjects affected / exposed
|
20 / 542 (3.69%) |
1 / 93 (1.08%) |
11 / 540 (2.04%) |
occurrences all number
|
21 |
1 |
11 |
Hyperglycaemia
|
|
|
|
subjects affected / exposed
|
52 / 542 (9.59%) |
6 / 93 (6.45%) |
41 / 540 (7.59%) |
occurrences all number
|
93 |
7 |
74 |
Hyperkalaemia
|
|
|
|
subjects affected / exposed
|
12 / 542 (2.21%) |
1 / 93 (1.08%) |
11 / 540 (2.04%) |
occurrences all number
|
19 |
1 |
14 |
Hyperlipidaemia
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
1 |
0 |
1 |
Hypermagnesaemia
|
|
|
|
subjects affected / exposed
|
6 / 542 (1.11%) |
1 / 93 (1.08%) |
5 / 540 (0.93%) |
occurrences all number
|
14 |
1 |
8 |
Hypernatraemia
|
|
|
|
subjects affected / exposed
|
9 / 542 (1.66%) |
0 / 93 (0.00%) |
10 / 540 (1.85%) |
occurrences all number
|
20 |
0 |
14 |
Hyperphosphataemia
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
2 |
0 |
2 |
Hypertriglyceridaemia
|
|
|
|
subjects affected / exposed
|
8 / 542 (1.48%) |
2 / 93 (2.15%) |
5 / 540 (0.93%) |
occurrences all number
|
8 |
3 |
6 |
Hyperuricaemia
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
1 / 93 (1.08%) |
5 / 540 (0.93%) |
occurrences all number
|
4 |
1 |
6 |
Hypoalbuminaemia
|
|
|
|
subjects affected / exposed
|
5 / 542 (0.92%) |
3 / 93 (3.23%) |
5 / 540 (0.93%) |
occurrences all number
|
9 |
4 |
11 |
Hypocalcaemia
|
|
|
|
subjects affected / exposed
|
8 / 542 (1.48%) |
2 / 93 (2.15%) |
2 / 540 (0.37%) |
occurrences all number
|
12 |
2 |
5 |
Hypoglycaemia
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
4 / 540 (0.74%) |
occurrences all number
|
2 |
0 |
5 |
Hypokalaemia
|
|
|
|
subjects affected / exposed
|
99 / 542 (18.27%) |
9 / 93 (9.68%) |
68 / 540 (12.59%) |
occurrences all number
|
176 |
13 |
107 |
Hypomagnesaemia
|
|
|
|
subjects affected / exposed
|
7 / 542 (1.29%) |
2 / 93 (2.15%) |
6 / 540 (1.11%) |
occurrences all number
|
8 |
2 |
6 |
Hyponatraemia
|
|
|
|
subjects affected / exposed
|
14 / 542 (2.58%) |
5 / 93 (5.38%) |
15 / 540 (2.78%) |
occurrences all number
|
31 |
7 |
19 |
Hypophosphataemia
|
|
|
|
subjects affected / exposed
|
11 / 542 (2.03%) |
2 / 93 (2.15%) |
8 / 540 (1.48%) |
occurrences all number
|
20 |
2 |
19 |
Hypovolaemia
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Increased Appetite
|
|
|
|
subjects affected / exposed
|
10 / 542 (1.85%) |
0 / 93 (0.00%) |
11 / 540 (2.04%) |
occurrences all number
|
11 |
0 |
11 |
Malnutrition
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Metabolic Acidosis
|
|
|
|
subjects affected / exposed
|
0 / 542 (0.00%) |
0 / 93 (0.00%) |
1 / 540 (0.19%) |
occurrences all number
|
0 |
0 |
1 |
Polydipsia
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Tetany
|
|
|
|
subjects affected / exposed
|
1 / 542 (0.18%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Type 1 Diabetes Mellitus
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
0 / 93 (0.00%) |
0 / 540 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Type 2 Diabetes Mellitus
|
|
|
|
subjects affected / exposed
|
3 / 542 (0.55%) |
1 / 93 (1.08%) |
6 / 540 (1.11%) |
occurrences all number
|
3 |
1 |
6 |
Vitamin B12 Deficiency
|
|
|
|
subjects affected / exposed
|
2 / 542 (0.37%) |
1 / 93 (1.08%) |
3 / 540 (0.56%) |
occurrences all number
|
2 |
1 |
3 |
Vitamin D Deficiency
|
|
|
|
subjects affected / exposed
|
6 / 542 (1.11%) |
1 / 93 (1.08%) |
5 / 540 (0.93%) |
occurrences all number
|
6 |
1 |
5 |