Non-serious adverse events
|
BSor |
APlc |
CSor |
Total subjects affected by non serious adverse events
|
|
|
|
subjects affected / exposed
|
625 / 642 (97.35%) |
414 / 430 (96.28%) |
610 / 639 (95.46%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
Basal cell carcinoma
|
|
|
|
Additional description: Basal cell carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
1 |
1 |
Breast cancer in situ
|
|
|
|
Additional description: Breast cancer in situ
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Elastofibroma
|
|
|
|
Additional description: Elastofibroma
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Keratoacanthoma
|
|
|
|
Additional description: Keratoacanthoma
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
0 |
1 |
Lipoma
|
|
|
|
Additional description: Lipoma
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Malignant melanoma
|
|
|
|
Additional description: Malignant melanoma
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Melanocytic naevus
|
|
|
|
Additional description: Melanocytic naevus
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
2 / 639 (0.31%) |
occurrences all number
|
1 |
0 |
2 |
Meningioma
|
|
|
|
Additional description: Meningioma
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Papillary cystadenoma lymphomatosum
|
|
|
|
Additional description: Papillary cystadenoma lymphomatosum
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Pituitary tumour benign
|
|
|
|
Additional description: Pituitary tumour benign
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
2 |
Prostate cancer
|
|
|
|
Additional description: Prostate cancer
|
|
|
|
subjects affected / exposed
|
3 / 642 (0.47%) |
2 / 430 (0.47%) |
0 / 639 (0.00%) |
occurrences all number
|
3 |
3 |
0 |
Second primary malignancy
|
|
|
|
Additional description: Second primary malignancy
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
2 / 639 (0.31%) |
occurrences all number
|
1 |
0 |
2 |
Skin papilloma
|
|
|
|
Additional description: Skin papilloma
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
2 / 639 (0.31%) |
occurrences all number
|
0 |
1 |
2 |
Squamous cell carcinoma
|
|
|
|
Additional description: Squamous cell carcinoma
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
1 / 430 (0.23%) |
5 / 639 (0.78%) |
occurrences all number
|
2 |
1 |
9 |
Vascular disorders
|
|
|
|
Aneurysm
|
|
|
|
Additional description: Aneurysm
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Arterial spasm
|
|
|
|
Additional description: Arterial spasm
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Arterial occlusive disease
|
|
|
|
Additional description: Arterial occlusive disease
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Arteriosclerosis
|
|
|
|
Additional description: Arteriosclerosis
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Deep vein thrombosis
|
|
|
|
Additional description: Deep vein thrombosis
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
1 / 430 (0.23%) |
1 / 639 (0.16%) |
occurrences all number
|
2 |
1 |
1 |
Embolism
|
|
|
|
Additional description: Embolism
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Flushing
|
|
|
|
Additional description: Flushing
|
|
|
|
subjects affected / exposed
|
15 / 642 (2.34%) |
3 / 430 (0.70%) |
11 / 639 (1.72%) |
occurrences all number
|
19 |
8 |
14 |
Haematoma
|
|
|
|
Additional description: Haematoma
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
1 |
1 |
Hot flush
|
|
|
|
Additional description: Hot flush
|
|
|
|
subjects affected / exposed
|
6 / 642 (0.93%) |
5 / 430 (1.16%) |
6 / 639 (0.94%) |
occurrences all number
|
12 |
8 |
9 |
Hypertension
|
|
|
|
Additional description: Hypertension
|
|
|
|
subjects affected / exposed
|
377 / 642 (58.72%) |
203 / 430 (47.21%) |
394 / 639 (61.66%) |
occurrences all number
|
1545 |
999 |
1784 |
Hypotension
|
|
|
|
Additional description: Hypotension
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
Intermittent claudication
|
|
|
|
Additional description: Intermittent claudication
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Ischaemic limb pain
|
|
|
|
Additional description: Ischaemic limb pain
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Orthostatic hypotension
|
|
|
|
Additional description: Orthostatic hypotension
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Peripheral coldness
|
|
|
|
Additional description: Peripheral coldness
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
4 |
Phlebitis
|
|
|
|
Additional description: Phlebitis
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
2 / 430 (0.47%) |
2 / 639 (0.31%) |
occurrences all number
|
0 |
2 |
2 |
Thrombosis
|
|
|
|
Additional description: Thrombosis
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
0 |
1 |
Varicose vein
|
|
|
|
Additional description: Varicose vein
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Surgical and medical procedures
|
|
|
|
Appendicectomy
|
|
|
|
Additional description: Appendicectomy
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Artificial urinary sphincter implant
|
|
|
|
Additional description: Artificial urinary sphincter implant
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Bunion operation
|
|
|
|
Additional description: Bunion operation
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Cataract operation
|
|
|
|
Additional description: Cataract operation
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Cholecystectomy
|
|
|
|
Additional description: Cholecystectomy
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Coronary artery bypass
|
|
|
|
Additional description: Coronary artery bypass
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Cryotherapy
|
|
|
|
Additional description: Cryotherapy
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Elbow operation
|
|
|
|
Additional description: Elbow operation
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Gastric bypass
|
|
|
|
Additional description: Gastric bypass
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Genitourinary operation
|
|
|
|
Additional description: Genitourinary operation
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Hernia repair
|
|
|
|
Additional description: Hernia repair
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
2 |
1 |
0 |
Lesion excision
|
|
|
|
Additional description: Lesion excision
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Lipoma excision
|
|
|
|
Additional description: Lipoma excision
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Nail operation
|
|
|
|
Additional description: Nail operation
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Steroid therapy
|
|
|
|
Additional description: Steroid therapy
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Therapy cessation
|
|
|
|
Additional description: Therapy cessation
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Tooth extraction
|
|
|
|
Additional description: Tooth extraction
|
|
|
|
subjects affected / exposed
|
3 / 642 (0.47%) |
2 / 430 (0.47%) |
2 / 639 (0.31%) |
occurrences all number
|
3 |
2 |
2 |
Tooth repair
|
|
|
|
Additional description: Tooth repair
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
General disorders and administration site conditions
|
|
|
|
Asthenia
|
|
|
|
Additional description: Asthenia
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
1 |
4 |
Axillary pain
|
|
|
|
Additional description: Axillary pain
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Chest discomfort
|
|
|
|
Additional description: Chest discomfort
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
2 / 430 (0.47%) |
3 / 639 (0.47%) |
occurrences all number
|
1 |
6 |
3 |
Chest pain
|
|
|
|
Additional description: Chest pain
|
|
|
|
subjects affected / exposed
|
8 / 642 (1.25%) |
11 / 430 (2.56%) |
14 / 639 (2.19%) |
occurrences all number
|
8 |
13 |
15 |
Chills
|
|
|
|
Additional description: Chills
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Cyst
|
|
|
|
Additional description: Cyst
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
2 |
2 |
0 |
Discomfort
|
|
|
|
Additional description: Discomfort
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Face oedema
|
|
|
|
Additional description: Face oedema
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
0 |
1 |
Facial discomfort
|
|
|
|
Additional description: Facial discomfort
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Facial pain
|
|
|
|
Additional description: Facial pain
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Fatigue
|
|
|
|
Additional description: Fatigue
|
|
|
|
subjects affected / exposed
|
460 / 642 (71.65%) |
256 / 430 (59.53%) |
452 / 639 (70.74%) |
occurrences all number
|
1635 |
1144 |
1833 |
Feeling abnormal
|
|
|
|
Additional description: Feeling abnormal
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Feeling cold
|
|
|
|
Additional description: Feeling cold
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
0 |
1 |
Feeling hot
|
|
|
|
Additional description: Feeling hot
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
3 / 430 (0.70%) |
2 / 639 (0.31%) |
occurrences all number
|
0 |
3 |
3 |
Hernia
|
|
|
|
Additional description: Hernia
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
3 / 430 (0.70%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
3 |
0 |
Hernia pain
|
|
|
|
Additional description: Hernia pain
|
|
|
|
subjects affected / exposed
|
3 / 642 (0.47%) |
2 / 430 (0.47%) |
1 / 639 (0.16%) |
occurrences all number
|
3 |
2 |
3 |
Impaired healing
|
|
|
|
Additional description: Impaired healing
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
2 / 639 (0.31%) |
occurrences all number
|
1 |
1 |
4 |
Influenza like illness
|
|
|
|
Additional description: Influenza like illness
|
|
|
|
subjects affected / exposed
|
3 / 642 (0.47%) |
4 / 430 (0.93%) |
2 / 639 (0.31%) |
occurrences all number
|
3 |
6 |
2 |
Malaise
|
|
|
|
Additional description: Malaise
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
3 / 430 (0.70%) |
0 / 639 (0.00%) |
occurrences all number
|
2 |
3 |
0 |
Mucosal dryness
|
|
|
|
Additional description: Mucosal dryness
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Mucosal haemorrhage
|
|
|
|
Additional description: Mucosal haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Mucosal inflammation
|
|
|
|
Additional description: Mucosal inflammation
|
|
|
|
subjects affected / exposed
|
35 / 642 (5.45%) |
12 / 430 (2.79%) |
44 / 639 (6.89%) |
occurrences all number
|
54 |
15 |
67 |
Mucosal pain
|
|
|
|
Additional description: Mucosal pain
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Mucositis
|
|
|
|
Additional description: Mucositis
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Non-cardiac chest pain
|
|
|
|
Additional description: Non-cardiac chest pain
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Oedema peripheral
|
|
|
|
Additional description: Oedema peripheral
|
|
|
|
subjects affected / exposed
|
14 / 642 (2.18%) |
8 / 430 (1.86%) |
4 / 639 (0.63%) |
occurrences all number
|
19 |
11 |
5 |
Oedema
|
|
|
|
Additional description: Oedema
|
|
|
|
subjects affected / exposed
|
3 / 642 (0.47%) |
3 / 430 (0.70%) |
2 / 639 (0.31%) |
occurrences all number
|
3 |
3 |
2 |
Pain
|
|
|
|
Additional description: Pain
|
|
|
|
subjects affected / exposed
|
39 / 642 (6.07%) |
31 / 430 (7.21%) |
30 / 639 (4.69%) |
occurrences all number
|
56 |
50 |
45 |
Peripheral swelling
|
|
|
|
Additional description: Peripheral swelling
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
3 / 430 (0.70%) |
1 / 639 (0.16%) |
occurrences all number
|
2 |
3 |
1 |
Pyrexia
|
|
|
|
Additional description: Pyrexia
|
|
|
|
subjects affected / exposed
|
6 / 642 (0.93%) |
3 / 430 (0.70%) |
2 / 639 (0.31%) |
occurrences all number
|
7 |
3 |
2 |
Suprapubic pain
|
|
|
|
Additional description: Suprapubic pain
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
2 / 430 (0.47%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Swelling
|
|
|
|
Additional description: Swelling
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Swelling face
|
|
|
|
Additional description: Swelling face
|
|
|
|
subjects affected / exposed
|
3 / 642 (0.47%) |
0 / 430 (0.00%) |
4 / 639 (0.63%) |
occurrences all number
|
3 |
0 |
5 |
Temperature intolerance
|
|
|
|
Additional description: Temperature intolerance
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
2 / 639 (0.31%) |
occurrences all number
|
0 |
0 |
4 |
Tenderness
|
|
|
|
Additional description: Tenderness
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
0 |
1 |
Ulcer
|
|
|
|
Additional description: Ulcer
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Xerosis
|
|
|
|
Additional description: Xerosis
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
2 / 430 (0.47%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
2 |
2 |
Immune system disorders
|
|
|
|
Hypersensitivity
|
|
|
|
Additional description: Hypersensitivity
|
|
|
|
subjects affected / exposed
|
3 / 642 (0.47%) |
1 / 430 (0.23%) |
1 / 639 (0.16%) |
occurrences all number
|
4 |
1 |
1 |
Sarcoidosis
|
|
|
|
Additional description: Sarcoidosis
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Seasonal allergy
|
|
|
|
Additional description: Seasonal allergy
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
0 |
2 |
Reproductive system and breast disorders
|
|
|
|
Amenorrhoea
|
|
|
|
Additional description: Amenorrhoea
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Breast mass
|
|
|
|
Additional description: Breast mass
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Breast pain
|
|
|
|
Additional description: Breast pain
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Breast swelling
|
|
|
|
Additional description: Breast swelling
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Breast tenderness
|
|
|
|
Additional description: Breast tenderness
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Erectile dysfunction
|
|
|
|
Additional description: Erectile dysfunction
|
|
|
|
subjects affected / exposed
|
3 / 642 (0.47%) |
4 / 430 (0.93%) |
7 / 639 (1.10%) |
occurrences all number
|
4 |
4 |
14 |
Genital pain
|
|
|
|
Additional description: Genital pain
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Gynaecomastia
|
|
|
|
Additional description: Gynaecomastia
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
1 / 430 (0.23%) |
1 / 639 (0.16%) |
occurrences all number
|
3 |
1 |
1 |
Hydrocele
|
|
|
|
Additional description: Hydrocele
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Menorrhagia
|
|
|
|
Additional description: Menorrhagia
|
|
|
|
subjects affected / exposed
|
6 / 642 (0.93%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
9 |
0 |
1 |
Menstruation irregular
|
|
|
|
Additional description: Menstruation irregular
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Nipple enlargement
|
|
|
|
Additional description: Nipple enlargement
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
2 |
0 |
1 |
Nipple disorder
|
|
|
|
Additional description: Nipple disorder
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Nipple pain
|
|
|
|
Additional description: Nipple pain
|
|
|
|
subjects affected / exposed
|
12 / 642 (1.87%) |
0 / 430 (0.00%) |
8 / 639 (1.25%) |
occurrences all number
|
12 |
0 |
10 |
Orchitis noninfective
|
|
|
|
Additional description: Orchitis noninfective
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Pelvic pain
|
|
|
|
Additional description: Pelvic pain
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
3 / 430 (0.70%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
3 |
0 |
Perineal rash
|
|
|
|
Additional description: Perineal rash
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Perineal erythema
|
|
|
|
Additional description: Perineal erythema
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Prostatomegaly
|
|
|
|
Additional description: Prostatomegaly
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Scrotal pain
|
|
|
|
Additional description: Scrotal pain
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
3 |
0 |
0 |
Testicular mass
|
|
|
|
Additional description: Testicular mass
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Testicular pain
|
|
|
|
Additional description: Testicular pain
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
4 / 430 (0.93%) |
1 / 639 (0.16%) |
occurrences all number
|
2 |
5 |
1 |
Testicular swelling
|
|
|
|
Additional description: Testicular swelling
|
|
|
|
subjects affected / exposed
|
4 / 642 (0.62%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
5 |
2 |
0 |
Vaginal discharge
|
|
|
|
Additional description: Vaginal discharge
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
2 / 639 (0.31%) |
occurrences all number
|
0 |
1 |
2 |
Vaginal haemorrhage
|
|
|
|
Additional description: Vaginal haemorrhage
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
2 / 430 (0.47%) |
0 / 639 (0.00%) |
occurrences all number
|
3 |
4 |
0 |
Vulvovaginal inflammation
|
|
|
|
Additional description: Vulvovaginal inflammation
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Vulvovaginal pain
|
|
|
|
Additional description: Vulvovaginal pain
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Vulvovaginal pruritus
|
|
|
|
Additional description: Vulvovaginal pruritus
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
Asthma
|
|
|
|
Additional description: Asthma
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
2 / 430 (0.47%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
2 |
1 |
Bronchiectasis
|
|
|
|
Additional description: Bronchiectasis
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Cough
|
|
|
|
Additional description: Cough
|
|
|
|
subjects affected / exposed
|
14 / 642 (2.18%) |
20 / 430 (4.65%) |
16 / 639 (2.50%) |
occurrences all number
|
18 |
26 |
19 |
Dry throat
|
|
|
|
Additional description: Dry throat
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Dysphonia
|
|
|
|
Additional description: Dysphonia
|
|
|
|
subjects affected / exposed
|
29 / 642 (4.52%) |
8 / 430 (1.86%) |
41 / 639 (6.42%) |
occurrences all number
|
52 |
21 |
71 |
Dyspnoea
|
|
|
|
Additional description: Dyspnoea
|
|
|
|
subjects affected / exposed
|
24 / 642 (3.74%) |
23 / 430 (5.35%) |
31 / 639 (4.85%) |
occurrences all number
|
50 |
37 |
42 |
Epistaxis
|
|
|
|
Additional description: Epistaxis
|
|
|
|
subjects affected / exposed
|
8 / 642 (1.25%) |
5 / 430 (1.16%) |
16 / 639 (2.50%) |
occurrences all number
|
14 |
6 |
26 |
Lung disorder
|
|
|
|
Additional description: Lung disorder
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Nasal congestion
|
|
|
|
Additional description: Nasal congestion
|
|
|
|
subjects affected / exposed
|
3 / 642 (0.47%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
6 |
0 |
0 |
Nasal crusting
|
|
|
|
Additional description: Nasal crusting
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Nasal discomfort
|
|
|
|
Additional description: Nasal discomfort
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Nasal polyps
|
|
|
|
Additional description: Nasal polyps
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
5 |
0 |
0 |
Oropharyngeal pain
|
|
|
|
Additional description: Oropharyngeal pain
|
|
|
|
subjects affected / exposed
|
12 / 642 (1.87%) |
8 / 430 (1.86%) |
11 / 639 (1.72%) |
occurrences all number
|
16 |
11 |
17 |
Pharyngeal swelling
|
|
|
|
Additional description: Pharyngeal swelling
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Pneumothorax
|
|
|
|
Additional description: Pneumothorax
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Productive cough
|
|
|
|
Additional description: Productive cough
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
3 / 430 (0.70%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
3 |
2 |
Pulmonary embolism
|
|
|
|
Additional description: Pulmonary embolism
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
Respiratory disorder
|
|
|
|
Additional description: Respiratory disorder
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
2 |
1 |
0 |
Rhinitis allergic
|
|
|
|
Additional description: Rhinitis allergic
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
4 |
Rhinorrhoea
|
|
|
|
Additional description: Rhinorrhoea
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
1 / 430 (0.23%) |
1 / 639 (0.16%) |
occurrences all number
|
3 |
1 |
2 |
Sinus congestion
|
|
|
|
Additional description: Sinus congestion
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Sinus disorder
|
|
|
|
Additional description: Sinus disorder
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
2 |
Sleep apnoea syndrome
|
|
|
|
Additional description: Sleep apnoea syndrome
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
3 |
1 |
0 |
Sputum discoloured
|
|
|
|
Additional description: Sputum discoloured
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Testicular pain
|
|
|
|
Additional description: Testicular pain
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Throat irritation
|
|
|
|
Additional description: Throat irritation
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
2 |
1 |
Psychiatric disorders
|
|
|
|
Abnormal dreams
|
|
|
|
Additional description: Abnormal dreams
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Agitation
|
|
|
|
Additional description: Agitation
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
2 |
1 |
Anger
|
|
|
|
Additional description: Anger
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Anxiety
|
|
|
|
Additional description: Anxiety
|
|
|
|
subjects affected / exposed
|
7 / 642 (1.09%) |
14 / 430 (3.26%) |
8 / 639 (1.25%) |
occurrences all number
|
7 |
20 |
9 |
Confusional state
|
|
|
|
Additional description: Confusional state
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Depressed mood
|
|
|
|
Additional description: Depressed mood
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
4 / 430 (0.93%) |
9 / 639 (1.41%) |
occurrences all number
|
2 |
4 |
11 |
Depression
|
|
|
|
Additional description: Depression
|
|
|
|
subjects affected / exposed
|
8 / 642 (1.25%) |
10 / 430 (2.33%) |
17 / 639 (2.66%) |
occurrences all number
|
9 |
15 |
31 |
Emotional disorder
|
|
|
|
Additional description: Emotional disorder
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Frustration tolerance decreased
|
|
|
|
Additional description: Frustration tolerance decreased
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Insomnia
|
|
|
|
Additional description: Insomnia
|
|
|
|
subjects affected / exposed
|
8 / 642 (1.25%) |
11 / 430 (2.56%) |
7 / 639 (1.10%) |
occurrences all number
|
8 |
21 |
9 |
Irritability
|
|
|
|
Additional description: Irritability
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
4 |
Libido decreased
|
|
|
|
Additional description: Libido decreased
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
1 / 430 (0.23%) |
2 / 639 (0.31%) |
occurrences all number
|
2 |
1 |
4 |
Libido disorder
|
|
|
|
Additional description: Libido disorder
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
2 |
0 |
1 |
Loss of libido
|
|
|
|
Additional description: Loss of libido
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
2 / 639 (0.31%) |
occurrences all number
|
1 |
0 |
2 |
Mood altered
|
|
|
|
Additional description: Mood altered
|
|
|
|
subjects affected / exposed
|
7 / 642 (1.09%) |
4 / 430 (0.93%) |
9 / 639 (1.41%) |
occurrences all number
|
7 |
4 |
9 |
Mood swings
|
|
|
|
Additional description: Mood swings
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Nightmare
|
|
|
|
Additional description: Nightmare
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
2 / 430 (0.47%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
Personality change
|
|
|
|
Additional description: Personality change
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Psychotic disorder
|
|
|
|
Additional description: Psychotic disorder
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Sleep disorder
|
|
|
|
Additional description: Sleep disorder
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Tearfulness
|
|
|
|
Additional description: Tearfulness
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Investigations
|
|
|
|
Activated partial thromboplastin time prolonged
|
|
|
|
Additional description: Activated partial thromboplastin time prolonged
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Adjusted calcium
|
|
|
|
Additional description: Adjusted calcium
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Alanine aminotransferase abnormal
|
|
|
|
Additional description: Alanine aminotransferase abnormal
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
2 / 430 (0.47%) |
1 / 639 (0.16%) |
occurrences all number
|
3 |
3 |
1 |
Alanine aminotransferase increased
|
|
|
|
Additional description: Alanine aminotransferase increased
|
|
|
|
subjects affected / exposed
|
16 / 642 (2.49%) |
5 / 430 (1.16%) |
19 / 639 (2.97%) |
occurrences all number
|
20 |
11 |
27 |
Amylase abnormal
|
|
|
|
Additional description: Amylase abnormal
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Amylase increased
|
|
|
|
Additional description: Amylase increased
|
|
|
|
subjects affected / exposed
|
3 / 642 (0.47%) |
2 / 430 (0.47%) |
6 / 639 (0.94%) |
occurrences all number
|
3 |
2 |
7 |
Aspartate aminotransferase abnormal
|
|
|
|
Additional description: Aspartate aminotransferase abnormal
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Aspartate aminotransferase increased
|
|
|
|
Additional description: Aspartate aminotransferase increased
|
|
|
|
subjects affected / exposed
|
4 / 642 (0.62%) |
2 / 430 (0.47%) |
5 / 639 (0.78%) |
occurrences all number
|
4 |
2 |
5 |
Biopsy
|
|
|
|
Additional description: Biopsy
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Blood alkaline phosphatase abnormal
|
|
|
|
Additional description: Blood alkaline phosphatase abnormal
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
0 |
1 |
Blood alkaline phosphatase increased
|
|
|
|
Additional description: Blood alkaline phosphatase increased
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
0 |
2 |
Blood bilirubin increased
|
|
|
|
Additional description: Blood bilirubin increased
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
0 / 430 (0.00%) |
3 / 639 (0.47%) |
occurrences all number
|
2 |
0 |
4 |
Blood calcium decreased
|
|
|
|
Additional description: Blood calcium decreased
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
2 / 639 (0.31%) |
occurrences all number
|
0 |
0 |
2 |
Blood cholesterol increased
|
|
|
|
Additional description: Blood cholesterol increased
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
2 / 430 (0.47%) |
1 / 639 (0.16%) |
occurrences all number
|
3 |
2 |
1 |
Blood creatine abnormal
|
|
|
|
Additional description: Blood creatine abnormal
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
2 / 430 (0.47%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
2 |
2 |
Blood creatine increased
|
|
|
|
Additional description: Blood creatine increased
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Blood creatine phosphokinase
|
|
|
|
Additional description: Blood creatine phosphokinase
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Blood creatine phosphokinase increased
|
|
|
|
Additional description: Blood creatine phosphokinase increased
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
5 |
0 |
1 |
Blood creatinine abnormal
|
|
|
|
Additional description: Blood creatinine abnormal
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
2 / 430 (0.47%) |
3 / 639 (0.47%) |
occurrences all number
|
2 |
5 |
3 |
Blood creatinine increased
|
|
|
|
Additional description: Blood creatinine increased
|
|
|
|
subjects affected / exposed
|
28 / 642 (4.36%) |
28 / 430 (6.51%) |
18 / 639 (2.82%) |
occurrences all number
|
44 |
49 |
27 |
Blood glucose increased
|
|
|
|
Additional description: Blood glucose increased
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
2 / 639 (0.31%) |
occurrences all number
|
0 |
1 |
3 |
Blood iron decreased
|
|
|
|
Additional description: Blood iron decreased
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Blood lactate dehydrogenase abnormal
|
|
|
|
Additional description: Blood lactate dehydrogenase abnormal
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
2 / 430 (0.47%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Blood lactate dehydrogenase increased
|
|
|
|
Additional description: Blood lactate dehydrogenase increased
|
|
|
|
subjects affected / exposed
|
4 / 642 (0.62%) |
4 / 430 (0.93%) |
3 / 639 (0.47%) |
occurrences all number
|
5 |
5 |
5 |
Blood phosphorus abnormal
|
|
|
|
Additional description: Blood phosphorus abnormal
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Blood phosphorus decreased
|
|
|
|
Additional description: Blood phosphorus decreased
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
4 / 639 (0.63%) |
occurrences all number
|
0 |
1 |
4 |
Blood potassium increased
|
|
|
|
Additional description: Blood potassium increased
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
3 / 430 (0.70%) |
8 / 639 (1.25%) |
occurrences all number
|
0 |
4 |
10 |
Blood test abnormal
|
|
|
|
Additional description: Blood test abnormal
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Blood testosterone decreased
|
|
|
|
Additional description: Blood testosterone decreased
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Blood triglycerides abnormal
|
|
|
|
Additional description: Blood triglycerides abnormal
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Blood urea abnormal
|
|
|
|
Additional description: Blood urea abnormal
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
3 / 430 (0.70%) |
1 / 639 (0.16%) |
occurrences all number
|
2 |
8 |
2 |
Blood urea increased
|
|
|
|
Additional description: Blood urea increased
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
7 / 430 (1.63%) |
3 / 639 (0.47%) |
occurrences all number
|
2 |
10 |
5 |
Blood uric acid increased
|
|
|
|
Additional description: Blood uric acid increased
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Blood urine present
|
|
|
|
Additional description: Blood urine present
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
1 |
1 |
Colonoscopy
|
|
|
|
Additional description: Colonoscopy
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
2 / 639 (0.31%) |
occurrences all number
|
1 |
0 |
2 |
Full blood count abnormal
|
|
|
|
Additional description: Full blood count abnormal
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Gamma-glutamyltransferase abnormal
|
|
|
|
Additional description: Gamma-glutamyltransferase abnormal
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Gamma-glutamyltransferase increased
|
|
|
|
Additional description: Gamma-glutamyltransferase increased
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
3 / 430 (0.70%) |
3 / 639 (0.47%) |
occurrences all number
|
2 |
3 |
3 |
Gastric pH increased
|
|
|
|
Additional description: Gastric pH increased
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
2 |
1 |
Globulins increased
|
|
|
|
Additional description: Globulins increased
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Glomerular filtration rate decreased
|
|
|
|
Additional description: Glomerular filtration rate decreased
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
3 |
0 |
Haemoglobin decreased
|
|
|
|
Additional description: Haemoglobin decreased
|
|
|
|
subjects affected / exposed
|
4 / 642 (0.62%) |
4 / 430 (0.93%) |
6 / 639 (0.94%) |
occurrences all number
|
8 |
5 |
8 |
Hepatic enzyme increased
|
|
|
|
Additional description: Hepatic enzyme increased
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Lipase increased
|
|
|
|
Additional description: Lipase increased
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Liver function test increased
|
|
|
|
Additional description: Liver function test increased
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
2 |
0 |
1 |
Liver function test abnormal
|
|
|
|
Additional description: Liver function test abnormal
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
2 / 639 (0.31%) |
occurrences all number
|
0 |
0 |
2 |
Monocyte count increased
|
|
|
|
Additional description: Monocyte count increased
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Neutrophil count decreased
|
|
|
|
Additional description: Neutrophil count decreased
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
2 / 430 (0.47%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Platelet analyses
|
|
|
|
Additional description: Platelet analyses
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Platelet count decreased
|
|
|
|
Additional description: Platelet count decreased
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
1 / 430 (0.23%) |
2 / 639 (0.31%) |
occurrences all number
|
5 |
1 |
4 |
Prostatic specific antigen abnormal
|
|
|
|
Additional description: Prostatic specific antigen abnormal
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Prostatic specific antigen increased
|
|
|
|
Additional description: Prostatic specific antigen increased
|
|
|
|
subjects affected / exposed
|
3 / 642 (0.47%) |
2 / 430 (0.47%) |
0 / 639 (0.00%) |
occurrences all number
|
5 |
4 |
0 |
Red blood cell count decreased
|
|
|
|
Additional description: Red blood cell count decreased
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Rheumatoid factor
|
|
|
|
Additional description: Rheumatoid factor
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Transaminases increased
|
|
|
|
Additional description: Transaminases increased
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
2 / 639 (0.31%) |
occurrences all number
|
0 |
0 |
3 |
Vitamin D decreased
|
|
|
|
Additional description: Vitamin D decreased
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Weight decreased
|
|
|
|
Additional description: Weight decreased
|
|
|
|
subjects affected / exposed
|
11 / 642 (1.71%) |
3 / 430 (0.70%) |
7 / 639 (1.10%) |
occurrences all number
|
15 |
3 |
9 |
Weight increased
|
|
|
|
Additional description: Weight increased
|
|
|
|
subjects affected / exposed
|
4 / 642 (0.62%) |
1 / 430 (0.23%) |
2 / 639 (0.31%) |
occurrences all number
|
6 |
1 |
2 |
White blood cell count decreased
|
|
|
|
Additional description: White blood cell count decreased
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Injury, poisoning and procedural complications
|
|
|
|
Ankle fracture
|
|
|
|
Additional description: Ankle fracture
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Arthropod bite
|
|
|
|
Additional description: Arthropod bite
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Burn oesophageal
|
|
|
|
Additional description: Burn oesophageal
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Contusion
|
|
|
|
Additional description: Contusion
|
|
|
|
subjects affected / exposed
|
3 / 642 (0.47%) |
2 / 430 (0.47%) |
0 / 639 (0.00%) |
occurrences all number
|
5 |
2 |
0 |
Foot fracture
|
|
|
|
Additional description: Foot fracture
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Hand fracture
|
|
|
|
Additional description: Hand fracture
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
3 / 639 (0.47%) |
occurrences all number
|
0 |
0 |
4 |
Hernia pain
|
|
|
|
Additional description: Hernia pain
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Incisional hernia
|
|
|
|
Additional description: Incisional hernia
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Incision site complication
|
|
|
|
Additional description: Incision site complication
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
2 / 639 (0.31%) |
occurrences all number
|
1 |
1 |
2 |
Inflammation of wound
|
|
|
|
Additional description: Inflammation of wound
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Joint injury
|
|
|
|
Additional description: Joint injury
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Ligament sprain
|
|
|
|
Additional description: Ligament sprain
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Meniscus injury
|
|
|
|
Additional description: Meniscus injury
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Muscle strain
|
|
|
|
Additional description: Muscle strain
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Nail avulsion
|
|
|
|
Additional description: Nail avulsion
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Nail injury
|
|
|
|
Additional description: Nail injury
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Procedural pain
|
|
|
|
Additional description: Procedural pain
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
3 / 430 (0.70%) |
0 / 639 (0.00%) |
occurrences all number
|
2 |
3 |
0 |
Rib fracture
|
|
|
|
Additional description: Rib fracture
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
1 |
1 |
Skin injury
|
|
|
|
Additional description: Skin injury
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
2 / 430 (0.47%) |
2 / 639 (0.31%) |
occurrences all number
|
1 |
2 |
2 |
Stoma complication
|
|
|
|
Additional description: Stoma complication
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Sunburn
|
|
|
|
Additional description: Sunburn
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
1 / 430 (0.23%) |
2 / 639 (0.31%) |
occurrences all number
|
2 |
1 |
2 |
Thermal burn
|
|
|
|
Additional description: Thermal burn
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Tibia fracture
|
|
|
|
Additional description: Tibia fracture
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Trauma
|
|
|
|
Additional description: Trauma
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Upper limb fracture
|
|
|
|
Additional description: Upper limb fracture
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Wound complication
|
|
|
|
Additional description: Wound complication
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Wrist fracture
|
|
|
|
Additional description: Wrist fracture
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Cardiac disorders
|
|
|
|
Angina pectoris
|
|
|
|
Additional description: Angina pectoris
|
|
|
|
subjects affected / exposed
|
3 / 642 (0.47%) |
1 / 430 (0.23%) |
1 / 639 (0.16%) |
occurrences all number
|
11 |
1 |
1 |
Arrhythmia
|
|
|
|
Additional description: Arrhythmia
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Atrial fibrillation
|
|
|
|
Additional description: Atrial fibrillation
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
2 / 430 (0.47%) |
3 / 639 (0.47%) |
occurrences all number
|
2 |
4 |
3 |
Atrioventricular block
|
|
|
|
Additional description: Atrioventricular block
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Atrioventricular block second degree
|
|
|
|
Additional description: Atrioventricular block second degree
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Bradycardia
|
|
|
|
Additional description: Bradycardia
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Cardiac disorder
|
|
|
|
Additional description: Cardiac disorder
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Cardiac valve disease
|
|
|
|
Additional description: Cardiac valve disease
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Extrasystoles
|
|
|
|
Additional description: Extrasystoles
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Myocardial infarction
|
|
|
|
Additional description: Myocardial infarction
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
2 / 639 (0.31%) |
occurrences all number
|
1 |
0 |
2 |
Myocardial ischaemia
|
|
|
|
Additional description: Myocardial ischaemia
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
3 / 639 (0.47%) |
occurrences all number
|
0 |
0 |
3 |
Palpitations
|
|
|
|
Additional description: Palpitations
|
|
|
|
subjects affected / exposed
|
3 / 642 (0.47%) |
5 / 430 (1.16%) |
0 / 639 (0.00%) |
occurrences all number
|
3 |
5 |
0 |
Nervous system disorders
|
|
|
|
Ageusia
|
|
|
|
Additional description: Ageusia
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
3 / 430 (0.70%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
5 |
1 |
Amnesia
|
|
|
|
Additional description: Amnesia
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
3 / 430 (0.70%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
4 |
1 |
Anosmia
|
|
|
|
Additional description: Anosmia
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Aphasia
|
|
|
|
Additional description: Aphasia
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Balance disorder
|
|
|
|
Additional description: Balance disorder
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
1 |
1 |
Burning sensation
|
|
|
|
Additional description: Burning sensation
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
4 / 430 (0.93%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
6 |
1 |
Carpal tunnel syndrome
|
|
|
|
Additional description: Carpal tunnel syndrome
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
3 / 430 (0.70%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
5 |
1 |
Cluster headache
|
|
|
|
Additional description: Cluster headache
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Cognitive and attention disorders and disturbances NEC
|
|
|
|
Additional description: Cognitive and attention disorders and disturbances NEC
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
4 |
0 |
Diabetic neuropathy
|
|
|
|
Additional description: Diabetic neuropathy
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Disturbance in attention
|
|
|
|
Additional description: Disturbance in attention
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
2 / 430 (0.47%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
7 |
0 |
Dizziness
|
|
|
|
Additional description: Dizziness
|
|
|
|
subjects affected / exposed
|
15 / 642 (2.34%) |
21 / 430 (4.88%) |
8 / 639 (1.25%) |
occurrences all number
|
20 |
25 |
11 |
Dizziness postural
|
|
|
|
Additional description: Dizziness postural
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Dysaesthesia
|
|
|
|
Additional description: Dysaesthesia
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
2 / 639 (0.31%) |
occurrences all number
|
1 |
0 |
3 |
Dysgeusia
|
|
|
|
Additional description: Dysgeusia
|
|
|
|
subjects affected / exposed
|
4 / 642 (0.62%) |
2 / 430 (0.47%) |
7 / 639 (1.10%) |
occurrences all number
|
4 |
6 |
8 |
Facial paralysis
|
|
|
|
Additional description: Facial paralysis
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Head discomfort
|
|
|
|
Additional description: Head discomfort
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Headache
|
|
|
|
Additional description: Headache
|
|
|
|
subjects affected / exposed
|
50 / 642 (7.79%) |
35 / 430 (8.14%) |
55 / 639 (8.61%) |
occurrences all number
|
73 |
58 |
68 |
Hydrocephalus
|
|
|
|
Additional description: Hydrocephalus
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Hyperaesthesia
|
|
|
|
Additional description: Hyperaesthesia
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
0 |
1 |
Hypoaesthesia
|
|
|
|
Additional description: Hypoaesthesia
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
4 |
0 |
Lethargy
|
|
|
|
Additional description: Lethargy
|
|
|
|
subjects affected / exposed
|
4 / 642 (0.62%) |
0 / 430 (0.00%) |
4 / 639 (0.63%) |
occurrences all number
|
4 |
0 |
7 |
Loss of consciousness
|
|
|
|
Additional description: Loss of consciousness
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
2 / 430 (0.47%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
3 |
1 |
Memory impairment
|
|
|
|
Additional description: Memory impairment
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
0 |
3 |
Migraine
|
|
|
|
Additional description: Migraine
|
|
|
|
subjects affected / exposed
|
5 / 642 (0.78%) |
2 / 430 (0.47%) |
1 / 639 (0.16%) |
occurrences all number
|
5 |
2 |
2 |
Nervous system disorder
|
|
|
|
Additional description: Nervous system disorder
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
2 / 639 (0.31%) |
occurrences all number
|
1 |
0 |
2 |
Neuralgia
|
|
|
|
Additional description: Neuralgia
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
2 / 639 (0.31%) |
occurrences all number
|
0 |
2 |
5 |
Neuropathy peripheral
|
|
|
|
Additional description: Neuropathy peripheral
|
|
|
|
subjects affected / exposed
|
7 / 642 (1.09%) |
4 / 430 (0.93%) |
10 / 639 (1.56%) |
occurrences all number
|
8 |
4 |
10 |
Neurotoxicity
|
|
|
|
Additional description: Neurotoxicity
|
|
|
|
subjects affected / exposed
|
3 / 642 (0.47%) |
1 / 430 (0.23%) |
3 / 639 (0.47%) |
occurrences all number
|
4 |
1 |
3 |
Paraesthesia
|
|
|
|
Additional description: Paraesthesia
|
|
|
|
subjects affected / exposed
|
18 / 642 (2.80%) |
14 / 430 (3.26%) |
18 / 639 (2.82%) |
occurrences all number
|
23 |
29 |
29 |
Parkinson's disease
|
|
|
|
Additional description: Parkinson's disease
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Peripheral motor neuropathy
|
|
|
|
Additional description: Peripheral motor neuropathy
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Peripheral sensory neuropathy
|
|
|
|
Additional description: Peripheral sensory neuropathy
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
2 / 430 (0.47%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
Poor quality sleep
|
|
|
|
Additional description: Poor quality sleep
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Psychomotor hyperactivity
|
|
|
|
Additional description: Psychomotor hyperactivity
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Resting tremor
|
|
|
|
Additional description: Resting tremor
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Restless legs syndrome
|
|
|
|
Additional description: Restless legs syndrome
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Sciatica
|
|
|
|
Additional description: Sciatica
|
|
|
|
subjects affected / exposed
|
4 / 642 (0.62%) |
3 / 430 (0.70%) |
4 / 639 (0.63%) |
occurrences all number
|
4 |
11 |
7 |
Seizure
|
|
|
|
Additional description: Seizure
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Sensory neuropathy
|
|
|
|
Additional description: Sensory neuropathy
|
|
|
|
subjects affected / exposed
|
4 / 642 (0.62%) |
2 / 430 (0.47%) |
8 / 639 (1.25%) |
occurrences all number
|
9 |
10 |
14 |
Sinus headache
|
|
|
|
Additional description: Sinus headache
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Somnolence
|
|
|
|
Additional description: Somnolence
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
1 |
1 |
Syncope
|
|
|
|
Additional description: Syncope
|
|
|
|
subjects affected / exposed
|
3 / 642 (0.47%) |
2 / 430 (0.47%) |
4 / 639 (0.63%) |
occurrences all number
|
3 |
2 |
4 |
Taste disorder
|
|
|
|
Additional description: Taste disorder
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
5 / 430 (1.16%) |
5 / 639 (0.78%) |
occurrences all number
|
1 |
9 |
7 |
Transient global amnesia
|
|
|
|
Additional description: Transient global amnesia
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Transient ischaemic attack
|
|
|
|
Additional description: Transient ischaemic attack
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
0 / 430 (0.00%) |
2 / 639 (0.31%) |
occurrences all number
|
2 |
0 |
2 |
Tremor
|
|
|
|
Additional description: Tremor
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
5 |
0 |
0 |
Blood and lymphatic system disorders
|
|
|
|
Anaemia
|
|
|
|
Additional description: Anaemia
|
|
|
|
subjects affected / exposed
|
7 / 642 (1.09%) |
8 / 430 (1.86%) |
5 / 639 (0.78%) |
occurrences all number
|
9 |
8 |
7 |
Leukopenia
|
|
|
|
Additional description: Leukopenia
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Neutropenia
|
|
|
|
Additional description: Neutropenia
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
3 / 430 (0.70%) |
0 / 639 (0.00%) |
occurrences all number
|
4 |
5 |
0 |
Platelet disorder
|
|
|
|
Additional description: Platelet disorder
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Thrombocytopenia
|
|
|
|
Additional description: Thrombocytopenia
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
3 / 639 (0.47%) |
occurrences all number
|
1 |
1 |
3 |
Thrombocytosis
|
|
|
|
Additional description: Thrombocytosis
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Ear and labyrinth disorders
|
|
|
|
Deafness
|
|
|
|
Additional description: Deafness
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
3 |
0 |
5 |
Ear congestion
|
|
|
|
Additional description: Ear congestion
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Ear pain
|
|
|
|
Additional description: Ear pain
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
3 / 639 (0.47%) |
occurrences all number
|
0 |
0 |
3 |
Eustachian tube dysfunction
|
|
|
|
Additional description: Eustachian tube dysfunction
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
5 |
0 |
2 |
Hypoacusis
|
|
|
|
Additional description: Hypoacusis
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Tinnitus
|
|
|
|
Additional description: Tinnitus
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
6 / 430 (1.40%) |
8 / 639 (1.25%) |
occurrences all number
|
2 |
13 |
12 |
Vertigo
|
|
|
|
Additional description: Vertigo
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
1 |
1 |
Eye disorders
|
|
|
|
Amaurosis fugax
|
|
|
|
Additional description: Amaurosis fugax
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Astigmatism
|
|
|
|
Additional description: Astigmatism
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Blindness
|
|
|
|
Additional description: Blindness
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Chalazion
|
|
|
|
Additional description: Chalazion
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
0 |
1 |
Conjunctival haemorrhage
|
|
|
|
Additional description: Conjunctival haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Dry eye
|
|
|
|
Additional description: Dry eye
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
3 / 430 (0.70%) |
3 / 639 (0.47%) |
occurrences all number
|
4 |
3 |
4 |
Eye haemorrhage
|
|
|
|
Additional description: Eye haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Eye irritation
|
|
|
|
Additional description: Eye irritation
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
1 |
2 |
Eye pain
|
|
|
|
Additional description: Eye pain
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Eye pruritus
|
|
|
|
Additional description: Eye pruritus
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Eye swelling
|
|
|
|
Additional description: Eye swelling
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
2 / 639 (0.31%) |
occurrences all number
|
1 |
0 |
2 |
Eyelid cyst
|
|
|
|
Additional description: Eyelid cyst
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Eyelid irritation
|
|
|
|
Additional description: Eyelid irritation
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Eyelid oedema
|
|
|
|
Additional description: Eyelid oedema
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Foreign body sensation in eyes
|
|
|
|
Additional description: Foreign body sensation in eyes
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Glaucoma
|
|
|
|
Additional description: Glaucoma
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Iritis
|
|
|
|
Additional description: Iritis
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
2 / 639 (0.31%) |
occurrences all number
|
0 |
0 |
2 |
Keratitis
|
|
|
|
Additional description: Keratitis
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Lacrimation increased
|
|
|
|
Additional description: Lacrimation increased
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
1 |
1 |
Ocular hyperaemia
|
|
|
|
Additional description: Ocular hyperaemia
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Periorbital swelling
|
|
|
|
Additional description: Periorbital swelling
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Periorbital oedema
|
|
|
|
Additional description: Periorbital oedema
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Retinal detachment
|
|
|
|
Additional description: Retinal detachment
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Retinal haemorrhage
|
|
|
|
Additional description: Retinal haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Retinal vein occlusion
|
|
|
|
Additional description: Retinal vein occlusion
|
|
|
|
subjects affected / exposed
|
3 / 642 (0.47%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
13 |
1 |
0 |
Vision blurred
|
|
|
|
Additional description: Vision blurred
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
2 / 430 (0.47%) |
3 / 639 (0.47%) |
occurrences all number
|
2 |
6 |
3 |
Visual impairment
|
|
|
|
Additional description: Visual impairment
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
2 |
Gastrointestinal disorders
|
|
|
|
Abdominal discomfort
|
|
|
|
Additional description: Abdominal discomfort
|
|
|
|
subjects affected / exposed
|
6 / 642 (0.93%) |
4 / 430 (0.93%) |
4 / 639 (0.63%) |
occurrences all number
|
6 |
4 |
4 |
Abdominal distension
|
|
|
|
Additional description: Abdominal distension
|
|
|
|
subjects affected / exposed
|
9 / 642 (1.40%) |
8 / 430 (1.86%) |
6 / 639 (0.94%) |
occurrences all number
|
10 |
14 |
6 |
Abdominal hernia
|
|
|
|
Additional description: Abdominal hernia
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
2 / 430 (0.47%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
6 |
0 |
Abdominal pain
|
|
|
|
Additional description: Abdominal pain
|
|
|
|
subjects affected / exposed
|
39 / 642 (6.07%) |
32 / 430 (7.44%) |
53 / 639 (8.29%) |
occurrences all number
|
49 |
50 |
85 |
Abdominal pain lower
|
|
|
|
Additional description: Abdominal pain lower
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
5 / 430 (1.16%) |
4 / 639 (0.63%) |
occurrences all number
|
2 |
8 |
5 |
Abdominal pain upper
|
|
|
|
Additional description: Abdominal pain upper
|
|
|
|
subjects affected / exposed
|
20 / 642 (3.12%) |
10 / 430 (2.33%) |
22 / 639 (3.44%) |
occurrences all number
|
27 |
12 |
31 |
Abdominal tenderness
|
|
|
|
Additional description: Abdominal tenderness
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Abnormal faeces
|
|
|
|
Additional description: Abnormal faeces
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Anal fissure
|
|
|
|
Additional description: Anal fissure
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
0 |
1 |
Anal haemorrhage
|
|
|
|
Additional description: Anal haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
1 |
1 |
Anal inflammation
|
|
|
|
Additional description: Anal inflammation
|
|
|
|
subjects affected / exposed
|
3 / 642 (0.47%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
3 |
0 |
0 |
Anal pruritus
|
|
|
|
Additional description: Anal pruritus
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Aphthous ulcer
|
|
|
|
Additional description: Aphthous ulcer
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Change of bowel habit
|
|
|
|
Additional description: Change of bowel habit
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
3 |
1 |
0 |
Colitis
|
|
|
|
Additional description: Colitis
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Constipation
|
|
|
|
Additional description: Constipation
|
|
|
|
subjects affected / exposed
|
64 / 642 (9.97%) |
28 / 430 (6.51%) |
57 / 639 (8.92%) |
occurrences all number
|
95 |
53 |
86 |
Defaecation urgency
|
|
|
|
Additional description: Defaecation urgency
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Dental caries
|
|
|
|
Additional description: Dental caries
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Diarrhoea
|
|
|
|
Additional description: Diarrhoea
|
|
|
|
subjects affected / exposed
|
379 / 642 (59.03%) |
134 / 430 (31.16%) |
391 / 639 (61.19%) |
occurrences all number
|
1054 |
307 |
1644 |
Dry mouth
|
|
|
|
Additional description: Dry mouth
|
|
|
|
subjects affected / exposed
|
5 / 642 (0.78%) |
8 / 430 (1.86%) |
2 / 639 (0.31%) |
occurrences all number
|
6 |
9 |
2 |
Dyspepsia
|
|
|
|
Additional description: Dyspepsia
|
|
|
|
subjects affected / exposed
|
23 / 642 (3.58%) |
19 / 430 (4.42%) |
19 / 639 (2.97%) |
occurrences all number
|
31 |
43 |
35 |
Dysphagia
|
|
|
|
Additional description: Dysphagia
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
4 / 639 (0.63%) |
occurrences all number
|
1 |
1 |
5 |
Epigastric discomfort
|
|
|
|
Additional description: Epigastric discomfort
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
2 / 639 (0.31%) |
occurrences all number
|
0 |
1 |
2 |
Faecaloma
|
|
|
|
Additional description: Faecaloma
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Faeces discoloured
|
|
|
|
Additional description: Faeces discoloured
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Flatulence
|
|
|
|
Additional description: Flatulence
|
|
|
|
subjects affected / exposed
|
6 / 642 (0.93%) |
2 / 430 (0.47%) |
3 / 639 (0.47%) |
occurrences all number
|
7 |
3 |
6 |
Food poisoning
|
|
|
|
Additional description: Food poisoning
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Frequent bowel movements
|
|
|
|
Additional description: Frequent bowel movements
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
2 |
1 |
0 |
Gastric ulcer
|
|
|
|
Additional description: Gastric ulcer
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Gastritis
|
|
|
|
Additional description: Gastritis
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
3 / 430 (0.70%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
3 |
1 |
Gastrointestinal disorder
|
|
|
|
Additional description: Gastrointestinal disorder
|
|
|
|
subjects affected / exposed
|
6 / 642 (0.93%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
6 |
0 |
1 |
Gastrointestinal haemorrhage
|
|
|
|
Additional description: Gastrointestinal haemorrhage
|
|
|
|
subjects affected / exposed
|
6 / 642 (0.93%) |
1 / 430 (0.23%) |
7 / 639 (1.10%) |
occurrences all number
|
7 |
1 |
7 |
Gastrointestinal mucocoele
|
|
|
|
Additional description: Gastrointestinal mucocoele
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Gastrointestinal obstruction
|
|
|
|
Additional description: Gastrointestinal obstruction
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Gastrointestinal pain
|
|
|
|
Additional description: Gastrointestinal pain
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Gastrooesophageal reflux disease
|
|
|
|
Additional description: Gastrooesophageal reflux disease
|
|
|
|
subjects affected / exposed
|
8 / 642 (1.25%) |
3 / 430 (0.70%) |
8 / 639 (1.25%) |
occurrences all number
|
9 |
5 |
11 |
Gingival bleeding
|
|
|
|
Additional description: Gingival bleeding
|
|
|
|
subjects affected / exposed
|
7 / 642 (1.09%) |
2 / 430 (0.47%) |
6 / 639 (0.94%) |
occurrences all number
|
7 |
3 |
6 |
Gingival pain
|
|
|
|
Additional description: Gingival pain
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
2 |
0 |
1 |
Gingival ulceration
|
|
|
|
Additional description: Gingival ulceration
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Glossitis
|
|
|
|
Additional description: Glossitis
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
2 |
0 |
1 |
Glossodynia
|
|
|
|
Additional description: Glossodynia
|
|
|
|
subjects affected / exposed
|
11 / 642 (1.71%) |
0 / 430 (0.00%) |
10 / 639 (1.56%) |
occurrences all number
|
23 |
0 |
16 |
Haematemesis
|
|
|
|
Additional description: Haematemesis
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Haematochezia
|
|
|
|
Additional description: Haematochezia
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
5 / 430 (1.16%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
6 |
1 |
Haemorrhoids
|
|
|
|
Additional description: Haemorrhoids
|
|
|
|
subjects affected / exposed
|
5 / 642 (0.78%) |
1 / 430 (0.23%) |
6 / 639 (0.94%) |
occurrences all number
|
6 |
1 |
8 |
Hhaemorrhoids
|
|
|
|
Additional description: Hhaemorrhoids
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Hypoaesthesia oral
|
|
|
|
Additional description: Hypoaesthesia oral
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Inguinal hernia
|
|
|
|
Additional description: Inguinal hernia
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Intra-abdominal fluid collection
|
|
|
|
Additional description: Intra-abdominal fluid collection
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Lip swelling
|
|
|
|
Additional description: Lip swelling
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Lower gastrointestinal haemorrhage
|
|
|
|
Additional description: Lower gastrointestinal haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Mouth haemorrhage
|
|
|
|
Additional description: Mouth haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
2 / 639 (0.31%) |
occurrences all number
|
0 |
1 |
2 |
Mouth ulceration
|
|
|
|
Additional description: Mouth ulceration
|
|
|
|
subjects affected / exposed
|
12 / 642 (1.87%) |
6 / 430 (1.40%) |
12 / 639 (1.88%) |
occurrences all number
|
13 |
9 |
12 |
Mucous stools
|
|
|
|
Additional description: Mucous stools
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Nausea
|
|
|
|
Additional description: Nausea
|
|
|
|
subjects affected / exposed
|
211 / 642 (32.87%) |
111 / 430 (25.81%) |
186 / 639 (29.11%) |
occurrences all number
|
385 |
264 |
390 |
Oesophagitis
|
|
|
|
Additional description: Oesophagitis
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
0 |
1 |
Oral discomfort
|
|
|
|
Additional description: Oral discomfort
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Oral pain
|
|
|
|
Additional description: Oral pain
|
|
|
|
subjects affected / exposed
|
21 / 642 (3.27%) |
9 / 430 (2.09%) |
30 / 639 (4.69%) |
occurrences all number
|
27 |
13 |
40 |
Pancreatic insufficiency
|
|
|
|
Additional description: Pancreatic insufficiency
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Pancreatitis
|
|
|
|
Additional description: Pancreatitis
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
4 |
0 |
1 |
Pancreatitis acute
|
|
|
|
Additional description: Pancreatitis acute
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Paraesthesia oral
|
|
|
|
Additional description: Paraesthesia oral
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Proctalgia
|
|
|
|
Additional description: Proctalgia
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
4 |
0 |
2 |
Proctitis
|
|
|
|
Additional description: Proctitis
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Rectal haemorrhage
|
|
|
|
Additional description: Rectal haemorrhage
|
|
|
|
subjects affected / exposed
|
3 / 642 (0.47%) |
4 / 430 (0.93%) |
6 / 639 (0.94%) |
occurrences all number
|
3 |
5 |
8 |
Salivary gland disorder
|
|
|
|
Additional description: Salivary gland disorder
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Salivary gland enlargement
|
|
|
|
Additional description: Salivary gland enlargement
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Stomatitis
|
|
|
|
Additional description: Stomatitis
|
|
|
|
subjects affected / exposed
|
60 / 642 (9.35%) |
17 / 430 (3.95%) |
63 / 639 (9.86%) |
occurrences all number
|
92 |
32 |
105 |
Swollen tongue
|
|
|
|
Additional description: Swollen tongue
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
0 |
1 |
Tongue discolouration
|
|
|
|
Additional description: Tongue discolouration
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Tongue ulceration
|
|
|
|
Additional description: Tongue ulceration
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
1 / 430 (0.23%) |
1 / 639 (0.16%) |
occurrences all number
|
2 |
1 |
1 |
Tongue dry
|
|
|
|
Additional description: Tongue dry
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Tooth disorder
|
|
|
|
Additional description: Tooth disorder
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Toothache
|
|
|
|
Additional description: Toothache
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
2 / 430 (0.47%) |
4 / 639 (0.63%) |
occurrences all number
|
4 |
2 |
9 |
Umbilical hernia
|
|
|
|
Additional description: Umbilical hernia
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Vomiting
|
|
|
|
Additional description: Vomiting
|
|
|
|
subjects affected / exposed
|
26 / 642 (4.05%) |
10 / 430 (2.33%) |
26 / 639 (4.07%) |
occurrences all number
|
32 |
12 |
39 |
Hepatobiliary disorders
|
|
|
|
Biliary colic
|
|
|
|
Additional description: Biliary colic
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Cholecystitis
|
|
|
|
Additional description: Cholecystitis
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
0 |
1 |
Cholelithiasis
|
|
|
|
Additional description: Cholelithiasis
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
2 / 639 (0.31%) |
occurrences all number
|
1 |
1 |
3 |
Hepatitis cholestatic
|
|
|
|
Additional description: Hepatitis cholestatic
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Hepatocellular injury
|
|
|
|
Additional description: Hepatocellular injury
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Hyperbilirubinaemia
|
|
|
|
Additional description: Hyperbilirubinaemia
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Skin and subcutaneous tissue disorders
|
|
|
|
Acne
|
|
|
|
Additional description: Acne
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Alopecia
|
|
|
|
Additional description: Alopecia
|
|
|
|
subjects affected / exposed
|
338 / 642 (52.65%) |
53 / 430 (12.33%) |
304 / 639 (47.57%) |
occurrences all number
|
703 |
112 |
787 |
Angioedema
|
|
|
|
Additional description: Angioedema
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Blister
|
|
|
|
Additional description: Blister
|
|
|
|
subjects affected / exposed
|
4 / 642 (0.62%) |
1 / 430 (0.23%) |
2 / 639 (0.31%) |
occurrences all number
|
4 |
1 |
2 |
Blood blister
|
|
|
|
Additional description: Blood blister
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
0 |
2 |
Dandruff
|
|
|
|
Additional description: Dandruff
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Dermatitis
|
|
|
|
Additional description: Dermatitis
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
1 |
1 |
Dermatitis contact
|
|
|
|
Additional description: Dermatitis contact
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Dermatitis exfoliative generalised
|
|
|
|
Additional description: Dermatitis exfoliative generalised
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
2 |
0 |
1 |
Dry skin
|
|
|
|
Additional description: Dry skin
|
|
|
|
subjects affected / exposed
|
46 / 642 (7.17%) |
25 / 430 (5.81%) |
39 / 639 (6.10%) |
occurrences all number
|
71 |
55 |
70 |
Dyshidrotic eczema
|
|
|
|
Additional description: Dyshidrotic eczema
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Eczema
|
|
|
|
Additional description: Eczema
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
2 |
1 |
0 |
Eczema asteatotic
|
|
|
|
Additional description: Eczema asteatotic
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Erythema
|
|
|
|
Additional description: Erythema
|
|
|
|
subjects affected / exposed
|
18 / 642 (2.80%) |
5 / 430 (1.16%) |
12 / 639 (1.88%) |
occurrences all number
|
23 |
5 |
17 |
Furuncle
|
|
|
|
Additional description: Furuncle
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Haemorrhage subcutaneous
|
|
|
|
Additional description: Haemorrhage subcutaneous
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Hair colour changes
|
|
|
|
Additional description: Hair colour changes
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
0 / 430 (0.00%) |
3 / 639 (0.47%) |
occurrences all number
|
2 |
0 |
4 |
Hair growth abnormal
|
|
|
|
Additional description: Hair growth abnormal
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
2 / 639 (0.31%) |
occurrences all number
|
1 |
0 |
2 |
Hair texture abnormal
|
|
|
|
Additional description: Hair texture abnormal
|
|
|
|
subjects affected / exposed
|
5 / 642 (0.78%) |
1 / 430 (0.23%) |
3 / 639 (0.47%) |
occurrences all number
|
5 |
1 |
6 |
Hand and foot syndrome
|
|
|
|
Additional description: Hand and foot syndrome
|
|
|
|
subjects affected / exposed
|
491 / 642 (76.48%) |
135 / 430 (31.40%) |
473 / 639 (74.02%) |
occurrences all number
|
1566 |
338 |
1910 |
Hidradenitis
|
|
|
|
Additional description: Hidradenitis
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Hyperhidrosis
|
|
|
|
Additional description: Hyperhidrosis
|
|
|
|
subjects affected / exposed
|
4 / 642 (0.62%) |
2 / 430 (0.47%) |
6 / 639 (0.94%) |
occurrences all number
|
4 |
3 |
10 |
Hyperkeratosis
|
|
|
|
Additional description: Hyperkeratosis
|
|
|
|
subjects affected / exposed
|
7 / 642 (1.09%) |
1 / 430 (0.23%) |
10 / 639 (1.56%) |
occurrences all number
|
9 |
3 |
17 |
Miliaria
|
|
|
|
Additional description: Miliaria
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Mucocutaneous rash
|
|
|
|
Additional description: Mucocutaneous rash
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Nail disorder
|
|
|
|
Additional description: Nail disorder
|
|
|
|
subjects affected / exposed
|
3 / 642 (0.47%) |
2 / 430 (0.47%) |
3 / 639 (0.47%) |
occurrences all number
|
3 |
5 |
4 |
Nail pitting
|
|
|
|
Additional description: Nail pitting
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Nail psoriasis
|
|
|
|
Additional description: Nail psoriasis
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Nail ridging
|
|
|
|
Additional description: Nail ridging
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Neurodermatitis
|
|
|
|
Additional description: Neurodermatitis
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Night sweats
|
|
|
|
Additional description: Night sweats
|
|
|
|
subjects affected / exposed
|
3 / 642 (0.47%) |
2 / 430 (0.47%) |
1 / 639 (0.16%) |
occurrences all number
|
3 |
2 |
1 |
Onychalgia
|
|
|
|
Additional description: Onychalgia
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Onychoclasis
|
|
|
|
Additional description: Onychoclasis
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
12 |
0 |
Pain of skin
|
|
|
|
Additional description: Pain of skin
|
|
|
|
subjects affected / exposed
|
23 / 642 (3.58%) |
6 / 430 (1.40%) |
27 / 639 (4.23%) |
occurrences all number
|
33 |
25 |
34 |
Palmar-plantar erythrodysaesthesia syndrome
|
|
|
|
Additional description: Palmar-plantar erythrodysaesthesia syndrome
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
4 |
0 |
Photosensitivity reaction
|
|
|
|
Additional description: Photosensitivity reaction
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
0 / 430 (0.00%) |
2 / 639 (0.31%) |
occurrences all number
|
2 |
0 |
5 |
Pigmentation disorder
|
|
|
|
Additional description: Pigmentation disorder
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Plantar erythema
|
|
|
|
Additional description: Plantar erythema
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Pruritis
|
|
|
|
Additional description: Pruritis
|
|
|
|
subjects affected / exposed
|
25 / 642 (3.89%) |
9 / 430 (2.09%) |
28 / 639 (4.38%) |
occurrences all number
|
33 |
9 |
43 |
Pruritus
|
|
|
|
Additional description: Pruritus
|
|
|
|
subjects affected / exposed
|
48 / 642 (7.48%) |
25 / 430 (5.81%) |
64 / 639 (10.02%) |
occurrences all number
|
68 |
34 |
93 |
Psoriasis
|
|
|
|
Additional description: Psoriasis
|
|
|
|
subjects affected / exposed
|
8 / 642 (1.25%) |
1 / 430 (0.23%) |
2 / 639 (0.31%) |
occurrences all number
|
12 |
1 |
11 |
Rash
|
|
|
|
Additional description: Rash
|
|
|
|
subjects affected / exposed
|
439 / 642 (68.38%) |
130 / 430 (30.23%) |
437 / 639 (68.39%) |
occurrences all number
|
1110 |
305 |
1174 |
Rash papular
|
|
|
|
Additional description: Rash papular
|
|
|
|
subjects affected / exposed
|
3 / 642 (0.47%) |
2 / 430 (0.47%) |
6 / 639 (0.94%) |
occurrences all number
|
3 |
4 |
9 |
Scar pain
|
|
|
|
Additional description: Scar pain
|
|
|
|
subjects affected / exposed
|
12 / 642 (1.87%) |
21 / 430 (4.88%) |
13 / 639 (2.03%) |
occurrences all number
|
13 |
34 |
16 |
Skin atrophy
|
|
|
|
Additional description: Skin atrophy
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Skin depigmentation
|
|
|
|
Additional description: Skin depigmentation
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Skin discolouration
|
|
|
|
Additional description: Skin discolouration
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Skin disorder
|
|
|
|
Additional description: Skin disorder
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
3 / 430 (0.70%) |
5 / 639 (0.78%) |
occurrences all number
|
2 |
3 |
5 |
Skin exfoliation
|
|
|
|
Additional description: Skin exfoliation
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Skin fissures
|
|
|
|
Additional description: Skin fissures
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Skin hypertrophy
|
|
|
|
Additional description: Skin hypertrophy
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
1 |
1 |
Skin irritation
|
|
|
|
Additional description: Skin irritation
|
|
|
|
subjects affected / exposed
|
4 / 642 (0.62%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
7 |
0 |
1 |
Skin lesion
|
|
|
|
Additional description: Skin lesion
|
|
|
|
subjects affected / exposed
|
4 / 642 (0.62%) |
1 / 430 (0.23%) |
4 / 639 (0.63%) |
occurrences all number
|
6 |
1 |
5 |
Skin mass
|
|
|
|
Additional description: Skin mass
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
2 / 639 (0.31%) |
occurrences all number
|
1 |
1 |
2 |
Skin papilloma
|
|
|
|
Additional description: Skin papilloma
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Skin reaction
|
|
|
|
Additional description: Skin reaction
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
0 |
1 |
Skin swelling
|
|
|
|
Additional description: Skin swelling
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
0 |
1 |
Skin tightness
|
|
|
|
Additional description: Skin tightness
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
2 / 639 (0.31%) |
occurrences all number
|
0 |
0 |
2 |
Skin toxicity
|
|
|
|
Additional description: Skin toxicity
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
2 |
0 |
1 |
Skin ulcer
|
|
|
|
Additional description: Skin ulcer
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
2 |
0 |
2 |
Splinter haemorrhages
|
|
|
|
Additional description: Splinter haemorrhages
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Toxic skin eruption
|
|
|
|
Additional description: Toxic skin eruption
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Urticaria
|
|
|
|
Additional description: Urticaria
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
1 |
1 |
Renal and urinary disorders
|
|
|
|
Bladder pain
|
|
|
|
Additional description: Bladder pain
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Chromaturia
|
|
|
|
Additional description: Chromaturia
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
0 |
1 |
Dysuria
|
|
|
|
Additional description: Dysuria
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
2 / 430 (0.47%) |
2 / 639 (0.31%) |
occurrences all number
|
0 |
4 |
3 |
Haematuria
|
|
|
|
Additional description: Haematuria
|
|
|
|
subjects affected / exposed
|
3 / 642 (0.47%) |
3 / 430 (0.70%) |
4 / 639 (0.63%) |
occurrences all number
|
3 |
7 |
5 |
Hypertonic bladder
|
|
|
|
Additional description: Hypertonic bladder
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Lower urinary tract symptoms
|
|
|
|
Additional description: Lower urinary tract symptoms
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Micturition urgency
|
|
|
|
Additional description: Micturition urgency
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
2 / 639 (0.31%) |
occurrences all number
|
5 |
1 |
2 |
Nephrolithiasis
|
|
|
|
Additional description: Nephrolithiasis
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Nocturia
|
|
|
|
Additional description: Nocturia
|
|
|
|
subjects affected / exposed
|
5 / 642 (0.78%) |
6 / 430 (1.40%) |
3 / 639 (0.47%) |
occurrences all number
|
7 |
18 |
3 |
Pollakiuria
|
|
|
|
Additional description: Pollakiuria
|
|
|
|
subjects affected / exposed
|
4 / 642 (0.62%) |
5 / 430 (1.16%) |
3 / 639 (0.47%) |
occurrences all number
|
5 |
9 |
3 |
Polyuria
|
|
|
|
Additional description: Polyuria
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Proteinuria
|
|
|
|
Additional description: Proteinuria
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
2 / 430 (0.47%) |
2 / 639 (0.31%) |
occurrences all number
|
1 |
2 |
2 |
Renal colic
|
|
|
|
Additional description: Renal colic
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Renal failure
|
|
|
|
Additional description: Renal failure
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
3 |
0 |
Renal pain
|
|
|
|
Additional description: Renal pain
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
4 / 430 (0.93%) |
2 / 639 (0.31%) |
occurrences all number
|
1 |
5 |
2 |
Renal vein occlusion
|
|
|
|
Additional description: Renal vein occlusion
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Testicular pain
|
|
|
|
Additional description: Testicular pain
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Urethral haemorrhage
|
|
|
|
Additional description: Urethral haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Urethral stenosis
|
|
|
|
Additional description: Urethral stenosis
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Urinary incontinence
|
|
|
|
Additional description: Urinary incontinence
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Urinary retention
|
|
|
|
Additional description: Urinary retention
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Urinary tract disorder
|
|
|
|
Additional description: Urinary tract disorder
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Urine abnormality
|
|
|
|
Additional description: Urine abnormality
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Urosepsis
|
|
|
|
Additional description: Urosepsis
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Endocrine disorders
|
|
|
|
Hyperparathyroidism
|
|
|
|
Additional description: Hyperparathyroidism
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
3 |
0 |
Hyperthyroidism
|
|
|
|
Additional description: Hyperthyroidism
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
Hypogonadism
|
|
|
|
Additional description: Hypogonadism
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Hypothyroidism
|
|
|
|
Additional description: Hypothyroidism
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
0 / 430 (0.00%) |
2 / 639 (0.31%) |
occurrences all number
|
2 |
0 |
4 |
Parathyroid disorder
|
|
|
|
Additional description: Parathyroid disorder
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Thyroid mass
|
|
|
|
Additional description: Thyroid mass
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
2 / 430 (0.47%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Thyroid disorder
|
|
|
|
Additional description: Thyroid disorder
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Thyroiditis
|
|
|
|
Additional description: Thyroiditis
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Musculoskeletal and connective tissue disorders
|
|
|
|
Abdominal pain upper
|
|
|
|
Additional description: Abdominal pain upper
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Arthralgia
|
|
|
|
Additional description: Arthralgia
|
|
|
|
subjects affected / exposed
|
48 / 642 (7.48%) |
57 / 430 (13.26%) |
48 / 639 (7.51%) |
occurrences all number
|
69 |
100 |
65 |
Arthritis
|
|
|
|
Additional description: Arthritis
|
|
|
|
subjects affected / exposed
|
5 / 642 (0.78%) |
8 / 430 (1.86%) |
5 / 639 (0.78%) |
occurrences all number
|
5 |
13 |
5 |
Arthropathy
|
|
|
|
Additional description: Arthropathy
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Axillary pain
|
|
|
|
Additional description: Axillary pain
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Back pain
|
|
|
|
Additional description: Back pain
|
|
|
|
subjects affected / exposed
|
44 / 642 (6.85%) |
72 / 430 (16.74%) |
44 / 639 (6.89%) |
occurrences all number
|
69 |
125 |
74 |
Bone pain
|
|
|
|
Additional description: Bone pain
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Bursitis
|
|
|
|
Additional description: Bursitis
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Fibromyalgia
|
|
|
|
Additional description: Fibromyalgia
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Fistula
|
|
|
|
Additional description: Fistula
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Flank pain
|
|
|
|
Additional description: Flank pain
|
|
|
|
subjects affected / exposed
|
6 / 642 (0.93%) |
12 / 430 (2.79%) |
8 / 639 (1.25%) |
occurrences all number
|
8 |
17 |
12 |
Groin pain
|
|
|
|
Additional description: Groin pain
|
|
|
|
subjects affected / exposed
|
6 / 642 (0.93%) |
7 / 430 (1.63%) |
3 / 639 (0.47%) |
occurrences all number
|
7 |
11 |
3 |
Intervertebral disc protrusion
|
|
|
|
Additional description: Intervertebral disc protrusion
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Joint stiffness
|
|
|
|
Additional description: Joint stiffness
|
|
|
|
subjects affected / exposed
|
3 / 642 (0.47%) |
6 / 430 (1.40%) |
3 / 639 (0.47%) |
occurrences all number
|
7 |
9 |
6 |
Joint swelling
|
|
|
|
Additional description: Joint swelling
|
|
|
|
subjects affected / exposed
|
8 / 642 (1.25%) |
4 / 430 (0.93%) |
2 / 639 (0.31%) |
occurrences all number
|
8 |
4 |
2 |
Ligament pain
|
|
|
|
Additional description: Ligament pain
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Limb discomfort
|
|
|
|
Additional description: Limb discomfort
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
2 / 430 (0.47%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
2 |
1 |
Limb mass
|
|
|
|
Additional description: Limb mass
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Mobility decreased
|
|
|
|
Additional description: Mobility decreased
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Muscle spasms
|
|
|
|
Additional description: Muscle spasms
|
|
|
|
subjects affected / exposed
|
25 / 642 (3.89%) |
10 / 430 (2.33%) |
35 / 639 (5.48%) |
occurrences all number
|
38 |
17 |
59 |
Muscular weakness
|
|
|
|
Additional description: Muscular weakness
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Musculoskeletal chest pain
|
|
|
|
Additional description: Musculoskeletal chest pain
|
|
|
|
subjects affected / exposed
|
4 / 642 (0.62%) |
2 / 430 (0.47%) |
4 / 639 (0.63%) |
occurrences all number
|
4 |
2 |
4 |
Musculoskeletal discomfort
|
|
|
|
Additional description: Musculoskeletal discomfort
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
4 / 430 (0.93%) |
2 / 639 (0.31%) |
occurrences all number
|
2 |
4 |
2 |
Musculoskeletal disorder
|
|
|
|
Additional description: Musculoskeletal disorder
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Musculoskeletal pain
|
|
|
|
Additional description: Musculoskeletal pain
|
|
|
|
subjects affected / exposed
|
4 / 642 (0.62%) |
4 / 430 (0.93%) |
0 / 639 (0.00%) |
occurrences all number
|
4 |
4 |
0 |
Musculoskeletal stiffness
|
|
|
|
Additional description: Musculoskeletal stiffness
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
2 / 430 (0.47%) |
2 / 639 (0.31%) |
occurrences all number
|
2 |
2 |
2 |
Myalgia
|
|
|
|
Additional description: Myalgia
|
|
|
|
subjects affected / exposed
|
19 / 642 (2.96%) |
10 / 430 (2.33%) |
16 / 639 (2.50%) |
occurrences all number
|
24 |
13 |
18 |
Myositis
|
|
|
|
Additional description: Myositis
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
2 |
Neck pain
|
|
|
|
Additional description: Neck pain
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
5 / 430 (1.16%) |
6 / 639 (0.94%) |
occurrences all number
|
2 |
5 |
7 |
Osteoarthritis
|
|
|
|
Additional description: Osteoarthritis
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Pain in extremity
|
|
|
|
Additional description: Pain in extremity
|
|
|
|
subjects affected / exposed
|
27 / 642 (4.21%) |
21 / 430 (4.88%) |
24 / 639 (3.76%) |
occurrences all number
|
33 |
27 |
33 |
Pain in jaw
|
|
|
|
Additional description: Pain in jaw
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
1 |
1 |
Pain of skin
|
|
|
|
Additional description: Pain of skin
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
0 |
1 |
Periarthritis
|
|
|
|
Additional description: Periarthritis
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
2 |
1 |
Plantar fasciitis
|
|
|
|
Additional description: Plantar fasciitis
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
2 / 430 (0.47%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
3 |
1 |
Polyarthritis
|
|
|
|
Additional description: Polyarthritis
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Polymyalgia rheumatica
|
|
|
|
Additional description: Polymyalgia rheumatica
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
3 |
0 |
0 |
Rheumatoid arthritis
|
|
|
|
Additional description: Rheumatoid arthritis
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Synovial cyst
|
|
|
|
Additional description: Synovial cyst
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Tendon pain
|
|
|
|
Additional description: Tendon pain
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Tendonitis
|
|
|
|
Additional description: Tendonitis
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
0 |
1 |
Tenosynovitis
|
|
|
|
Additional description: Tenosynovitis
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Trigger finger
|
|
|
|
Additional description: Trigger finger
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Infections and infestations
|
|
|
|
Abscess
|
|
|
|
Additional description: Abscess
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
3 / 639 (0.47%) |
occurrences all number
|
1 |
1 |
4 |
Anal abscess
|
|
|
|
Additional description: Anal abscess
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
3 / 639 (0.47%) |
occurrences all number
|
0 |
0 |
6 |
Balanitis candida
|
|
|
|
Additional description: Balanitis candida
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Bronchiolitis
|
|
|
|
Additional description: Bronchiolitis
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Bronchitis
|
|
|
|
Additional description: Bronchitis
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Candida infection
|
|
|
|
Additional description: Candida infection
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
2 / 430 (0.47%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
2 |
1 |
Cardiac infection
|
|
|
|
Additional description: Cardiac infection
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Cellulitis
|
|
|
|
Additional description: Cellulitis
|
|
|
|
subjects affected / exposed
|
5 / 642 (0.78%) |
0 / 430 (0.00%) |
3 / 639 (0.47%) |
occurrences all number
|
6 |
0 |
3 |
Conjunctivitis
|
|
|
|
Additional description: Conjunctivitis
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
2 |
1 |
0 |
Cystitis
|
|
|
|
Additional description: Cystitis
|
|
|
|
subjects affected / exposed
|
3 / 642 (0.47%) |
5 / 430 (1.16%) |
0 / 639 (0.00%) |
occurrences all number
|
3 |
5 |
0 |
Diverticulitis
|
|
|
|
Additional description: Diverticulitis
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
1 |
1 |
Ear infection
|
|
|
|
Additional description: Ear infection
|
|
|
|
subjects affected / exposed
|
3 / 642 (0.47%) |
0 / 430 (0.00%) |
3 / 639 (0.47%) |
occurrences all number
|
3 |
0 |
3 |
Ear infection fungal
|
|
|
|
Additional description: Ear infection fungal
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Epididymitis
|
|
|
|
Additional description: Epididymitis
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
2 |
Erysipelas
|
|
|
|
Additional description: Erysipelas
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Folliculitis
|
|
|
|
Additional description: Folliculitis
|
|
|
|
subjects affected / exposed
|
11 / 642 (1.71%) |
1 / 430 (0.23%) |
6 / 639 (0.94%) |
occurrences all number
|
15 |
1 |
8 |
Fungal infection
|
|
|
|
Additional description: Fungal infection
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
2 / 639 (0.31%) |
occurrences all number
|
0 |
0 |
2 |
Furuncle
|
|
|
|
Additional description: Furuncle
|
|
|
|
subjects affected / exposed
|
3 / 642 (0.47%) |
1 / 430 (0.23%) |
7 / 639 (1.10%) |
occurrences all number
|
4 |
1 |
9 |
Gastric infection
|
|
|
|
Additional description: Gastric infection
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
2 / 430 (0.47%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Gastroenteritis
|
|
|
|
Additional description: Gastroenteritis
|
|
|
|
subjects affected / exposed
|
3 / 642 (0.47%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
3 |
0 |
0 |
Gastroenteritis viral
|
|
|
|
Additional description: Gastroenteritis viral
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Genital candidiasis
|
|
|
|
Additional description: Genital candidiasis
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Gingivitis
|
|
|
|
Additional description: Gingivitis
|
|
|
|
subjects affected / exposed
|
4 / 642 (0.62%) |
1 / 430 (0.23%) |
1 / 639 (0.16%) |
occurrences all number
|
4 |
1 |
1 |
Groin abscess
|
|
|
|
Additional description: Groin abscess
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Groin infection
|
|
|
|
Additional description: Groin infection
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Helicobacter infection
|
|
|
|
Additional description: Helicobacter infection
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
2 / 430 (0.47%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Herpes virus infection
|
|
|
|
Additional description: Herpes virus infection
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
2 / 430 (0.47%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Herpes zoster
|
|
|
|
Additional description: Herpes zoster
|
|
|
|
subjects affected / exposed
|
3 / 642 (0.47%) |
2 / 430 (0.47%) |
0 / 639 (0.00%) |
occurrences all number
|
3 |
2 |
0 |
Hordeolum
|
|
|
|
Additional description: Hordeolum
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Infection
|
|
|
|
Additional description: Infection
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
3 / 430 (0.70%) |
4 / 639 (0.63%) |
occurrences all number
|
0 |
3 |
4 |
Influenza
|
|
|
|
Additional description: Influenza
|
|
|
|
subjects affected / exposed
|
3 / 642 (0.47%) |
2 / 430 (0.47%) |
0 / 639 (0.00%) |
occurrences all number
|
3 |
2 |
0 |
Labyrinthitis
|
|
|
|
Additional description: Labyrinthitis
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Localised infection
|
|
|
|
Additional description: Localised infection
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
2 / 430 (0.47%) |
2 / 639 (0.31%) |
occurrences all number
|
1 |
2 |
2 |
Lower respiratory tract infection
|
|
|
|
Additional description: Lower respiratory tract infection
|
|
|
|
subjects affected / exposed
|
9 / 642 (1.40%) |
13 / 430 (3.02%) |
17 / 639 (2.66%) |
occurrences all number
|
11 |
15 |
17 |
Nail infection
|
|
|
|
Additional description: Nail infection
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Nasopharyngitis
|
|
|
|
Additional description: Nasopharyngitis
|
|
|
|
subjects affected / exposed
|
8 / 642 (1.25%) |
11 / 430 (2.56%) |
7 / 639 (1.10%) |
occurrences all number
|
9 |
13 |
7 |
Onychomycosis
|
|
|
|
Additional description: Onychomycosis
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Oral candidiasis
|
|
|
|
Additional description: Oral candidiasis
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
1 |
1 |
Oral herpes
|
|
|
|
Additional description: Oral herpes
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
2 / 430 (0.47%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Paronychia
|
|
|
|
Additional description: Paronychia
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
3 |
0 |
0 |
Periodontitis
|
|
|
|
Additional description: Periodontitis
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Pharyngitis
|
|
|
|
Additional description: Pharyngitis
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
2 / 430 (0.47%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Pneumonia
|
|
|
|
Additional description: Pneumonia
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Pustule
|
|
|
|
Additional description: Pustule
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
1 / 430 (0.23%) |
3 / 639 (0.47%) |
occurrences all number
|
2 |
1 |
5 |
Respiratory tract infection
|
|
|
|
Additional description: Respiratory tract infection
|
|
|
|
subjects affected / exposed
|
3 / 642 (0.47%) |
1 / 430 (0.23%) |
2 / 639 (0.31%) |
occurrences all number
|
3 |
1 |
2 |
Rhinitis
|
|
|
|
Additional description: Rhinitis
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
1 / 430 (0.23%) |
2 / 639 (0.31%) |
occurrences all number
|
2 |
1 |
5 |
Sinusitis
|
|
|
|
Additional description: Sinusitis
|
|
|
|
subjects affected / exposed
|
3 / 642 (0.47%) |
1 / 430 (0.23%) |
2 / 639 (0.31%) |
occurrences all number
|
4 |
1 |
2 |
Skin infection
|
|
|
|
Additional description: Skin infection
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
1 |
1 |
Subcutaneous abscess
|
|
|
|
Additional description: Subcutaneous abscess
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Tetanus
|
|
|
|
Additional description: Tetanus
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Tinea pedis
|
|
|
|
Additional description: Tinea pedis
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Tonsillitis
|
|
|
|
Additional description: Tonsillitis
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Tooth abscess
|
|
|
|
Additional description: Tooth abscess
|
|
|
|
subjects affected / exposed
|
4 / 642 (0.62%) |
1 / 430 (0.23%) |
2 / 639 (0.31%) |
occurrences all number
|
4 |
1 |
2 |
Tooth infection
|
|
|
|
Additional description: Tooth infection
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
1 / 430 (0.23%) |
2 / 639 (0.31%) |
occurrences all number
|
2 |
1 |
2 |
Upper respiratory tract infection
|
|
|
|
Additional description: Upper respiratory tract infection
|
|
|
|
subjects affected / exposed
|
9 / 642 (1.40%) |
6 / 430 (1.40%) |
4 / 639 (0.63%) |
occurrences all number
|
9 |
7 |
4 |
Urinary tract infection
|
|
|
|
Additional description: Urinary tract infection
|
|
|
|
subjects affected / exposed
|
14 / 642 (2.18%) |
12 / 430 (2.79%) |
5 / 639 (0.78%) |
occurrences all number
|
18 |
20 |
5 |
Vaginal infection
|
|
|
|
Additional description: Vaginal infection
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Viral infection
|
|
|
|
Additional description: Viral infection
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
3 / 639 (0.47%) |
occurrences all number
|
1 |
0 |
3 |
Vulvovaginal candidiasis
|
|
|
|
Additional description: Vulvovaginal candidiasis
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Vulvovaginitis
|
|
|
|
Additional description: Vulvovaginitis
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Wound infection
|
|
|
|
Additional description: Wound infection
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
2 |
0 |
1 |
Metabolism and nutrition disorders
|
|
|
|
Cell death
|
|
|
|
Additional description: Cell death
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
2 / 639 (0.31%) |
occurrences all number
|
1 |
0 |
2 |
Decreased appetite
|
|
|
|
Additional description: Decreased appetite
|
|
|
|
subjects affected / exposed
|
42 / 642 (6.54%) |
8 / 430 (1.86%) |
44 / 639 (6.89%) |
occurrences all number
|
61 |
10 |
65 |
Dehydration
|
|
|
|
Additional description: Dehydration
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
2 / 430 (0.47%) |
1 / 639 (0.16%) |
occurrences all number
|
2 |
2 |
1 |
Diabetes mellitus
|
|
|
|
Additional description: Diabetes mellitus
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
2 / 430 (0.47%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
2 |
1 |
Diabetes mellitus (incl subtypes)
|
|
|
|
Additional description: Diabetes mellitus (incl subtypes)
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Diabetes mellitus inadequate control
|
|
|
|
Additional description: Diabetes mellitus inadequate control
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Fluid retention
|
|
|
|
Additional description: Fluid retention
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Gout
|
|
|
|
Additional description: Gout
|
|
|
|
subjects affected / exposed
|
5 / 642 (0.78%) |
4 / 430 (0.93%) |
6 / 639 (0.94%) |
occurrences all number
|
6 |
4 |
13 |
Hypercalcaemia
|
|
|
|
Additional description: Hypercalcaemia
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
3 / 430 (0.70%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
5 |
1 |
Hypercholesterolaemia
|
|
|
|
Additional description: Hypercholesterolaemia
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
4 |
9 |
0 |
Hyperglycaemia
|
|
|
|
Additional description: Hyperglycaemia
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
3 / 430 (0.70%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
5 |
4 |
Hyperkalaemia
|
|
|
|
Additional description: Hyperkalaemia
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
1 / 430 (0.23%) |
1 / 639 (0.16%) |
occurrences all number
|
1 |
1 |
2 |
Hyperlipidaemia
|
|
|
|
Additional description: Hyperlipidaemia
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
3 |
Hypertriglyceridaemia
|
|
|
|
Additional description: Hypertriglyceridaemia
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
1 / 430 (0.23%) |
0 / 639 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Hypocalcaemia
|
|
|
|
Additional description: Hypocalcaemia
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Hypoglycaemia
|
|
|
|
Additional description: Hypoglycaemia
|
|
|
|
subjects affected / exposed
|
0 / 642 (0.00%) |
0 / 430 (0.00%) |
1 / 639 (0.16%) |
occurrences all number
|
0 |
0 |
1 |
Hyponatraemia
|
|
|
|
Additional description: Hyponatraemia
|
|
|
|
subjects affected / exposed
|
3 / 642 (0.47%) |
1 / 430 (0.23%) |
1 / 639 (0.16%) |
occurrences all number
|
3 |
1 |
1 |
Hypophosphataemia
|
|
|
|
Additional description: Hypophosphataemia
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
1 / 430 (0.23%) |
2 / 639 (0.31%) |
occurrences all number
|
5 |
1 |
4 |
Type 2 diabetes mellitus
|
|
|
|
Additional description: Type 2 diabetes mellitus
|
|
|
|
subjects affected / exposed
|
2 / 642 (0.31%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Vitamin B12 deficiency
|
|
|
|
Additional description: Vitamin B12 deficiency
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Vitamin D deficiency
|
|
|
|
Additional description: Vitamin D deficiency
|
|
|
|
subjects affected / exposed
|
1 / 642 (0.16%) |
0 / 430 (0.00%) |
0 / 639 (0.00%) |
occurrences all number
|
1 |
0 |
0 |